FOR BIS USE ONLY

Doc No.: SM/IS14543 & IS13428/03

MANUAL
FOR
PACKAGED WATER
(Third Issue)

Date of Issue: March 2013

CONTENTS
Item

Chapter

Page No

Foreword

Introduction

Scope

Product Description

5-8

Grant of Licence

8-14

Operation of Certification

14-19

Guidelines for Assessment of Hygienic Conditions with

Explanatory Notes

19-35

Useful Tips for Inspecting Personnel & Guidelines for Reused

Containers

35-37

ANNEXES
1

Check List For Scrutiny of Application

38-39

Report of Preliminary Inspection

40-45

Verification Report By BIS IO

46-47

3A

Factory Testing Report

48

3B

Samples for Independent Testing

49

Check List For Good Hygiene (Applications)

50-54

Typical Manufacturing Process, Process Flow Chart,CIP Process

55-58

Check List for Red Form Processing

59-61

Report of Periodic Inspection

62-65

7A

Assessment of Compliance to IS 13428/IS 14543

66-67

7B

Details of Testing from OSL

Hygiene Check List (Licences)

List of Test Facilities

Organoleptic and Physical Requirements

71-73

Chemical Requirements

74-98

-Toxic Substances

99-105

-Microbiological Requirements

106-113

-Bottle / Container Requirements

-PE Flexible Pouch Requirements

68
69-70

114
115-116
2

0. FOREWORD
0.1
BIS has published two Indian Standards on packaged water for drinking purpose, namely, IS
13428 for Packaged Natural Mineral Water (PNMW) and IS 14543 for Packaged Drinking Water
(Other Than Packaged Natural Mineral Water) (PDW). Both the products were brought under
mandatory BIS certification effective from 29 March 2001 through two gazette notifications issued
by Ministry of Health and Family Welfare, namely GSR No. 759 for Packaged Natural Mineral
Water (PNMW) and GSR No. 760 for Packaged Drinking Water (PDW) as amendments to
Prevention of Food Adulteration Rules. Presently, these products under mandatory BIS certification
are covered under FSSAI regulation.
0.2
In the early stages of certification of PDW, different situations were handled differently by
ROs/BOs. This had necessitated issuance of several guidelines for creating uniformity in
certification of PDW throughout the country. Further, a need was felt to compile all these guidelines
into a manual. Thus, the Manual for PDW was brought out in the year 2005.
0.3
Revision of the Manual has been taken up to suitably incorporate the changes that had taken
place since 2005 in the certification of PDW and also in the general policies of product certification.
A specific sub-section for guidelines related to PNMW such as for constancy of source water and
criteria for decision seasonal variations etc introduced.
0.4
Packaged Drinking Water (Other Than Packaged Natural Mineral Water) (PDW) Packaged
Natural Mineral Water (PNMW) are basically packaged water for drinking purpose. Therefore, title
of this MANUAL is MANUAL FOR PACKAGED WATER.
0.5

Salient changes in this version of the Manual are as follows:

updation of the manual with respect to various amendments to IS 14543 and IS

13428 and guidelines issued from time to time;

incorporation of guidelines under simplified procedure for GOL and inclusion;

updation of the list of test equipment as per revised test methods wherever applicable;

inclusion of the list of test equipment for Bottles/Containers and PE Flexible Pouch for
Packaged Water; and
exclusion of the provision of verification by Chartered Engineer under the simplified
scheme for grant of licence.
This Manual is intended only for internal use by BIS officers and inspection personnel working on
behalf of BIS. However, others can draw benefit from the Manual to improve their activities related
to certification of PDW and PNMW.
Suggestions for any improvement in this Manual may be sent to CMD 2.

INTRODUCTION

1.1. The Standard IS 14543 provides sufficient freedom to the manufacturer to adopt any process
for converting raw water into packaged water for drinking purposes. Therefore, the required
manufacturing machinery for the purpose is neither specified in the respective Indian Standard nor
in this Manual. Illustrative examples have been given of typical manufacturing process with process
flow diagram, cleaning and disinfection (CIP) of plant and machinery, pipelines as well as of
containers in Annex 5.
1.2. However, there are restrictions with regard to processing of PNMW as specified in IS 13428,
such as the source water shall not be subjected to process steps, such as reverse osmosis,
demineralization or disinfection before packaging.
1.3. IS 13428 and 14543 prescribe a large number of requirements to be tested as per the methods
of tests given in the various cross-referred standards. Further, many requirements have options for
selection of test method to be followed. This has made the task of the inspecting official difficult
and time consuming for complete assessment of adequacy of the test facilities. This Manual
provides a ready reference for the inspecting official to check facilities for each of the requirements
against the method given under the relevant Indian Standard and the method chosen by the firm
(Annex 9).
1.4. All efforts have been made to incorporate details as per the latest versions of the standards.
However, as the standards are dynamic and subject to amendments and revisions, users are
encouraged to check the latest versions of the respective methods of test subsequent to issuance of
this issue of the Manual, before using the information contained herein.

2.

SCOPE

2.1
This Manual of Packaged Water provides guidelines for various aspects related to
certification of Packaged Natural Mineral Water and Packaged Drinking Water (Other Than
Packaged Natural Mineral Water) according to IS 13428 and IS 14543 respectively along with the
respective STIs. The provisions of these Indian Standards, STIs, as also the various guidelines issued
from time to time for certification of packaged water have been kept in view while preparing this
Manual.
2.2
Explanatory notes have been incorporated wherever necessary to take care of subjective
interpretations.
2.3
Specific proformas have been included for submission of reports of preliminary, periodic and
verification inspections so as to facilitate uniform reporting by all concerned, covering all essential
parameters required to be reported as per the relevant ISS, STI. Other proformas for checking plant,
process and personnel hygiene; processing of application; preparation of red form for grant of
licence; test equipment details etc have also been included.
2.4
In case of any deviation, the requirements of the Indian Standards and the corresponding STIs
shall prevail.
3.

PRODUCT DESCRIPTION

3.1

Packaged Drinking Water

3.1.1 Packaged drinking water means water derived from surface water or underground water or
sea water which may be subjected to specified treatments, namely, decantation, filtration,
combination of filtrations, aeration, filtration with membrane filter, depth filter, cartridge filter,
activated carbon filtration, demineralization, remineralization, reverse osmosis and packed after
disinfecting the water to a level that shall not lead to any harmful contamination in the drinking
water by means of chemical agents or physical methods to reduce the number of microorganisms to a
level beyond scientifically accepted level for food safety or its suitability: Provided that sea water,
before being subjected to the above treatments, shall be subjected to desalination and related
processes. It shall be filled in sealed containers of various compositions, forms and capacities that is
suitable for direct consumption without further treatment.
3.1.2 The water used for production of drinking water is water derived from any source of surface
water or underground water or sea water received on regular basis. Supplies of such water through
pipelines, tankers would be acceptable provided the source remains the same.
Note 1: It is the responsibility of the manufacturer to ensure that the source of raw water
remains the same. An undertaking in this regard shall be obtained from the manufacturer.
Note 2: Raw water supplies received through tankers, river, lake, pond etc. is acceptable,
provided treatment of such water is done as mentioned in 3.1.1.

3.1.3 As indicated above, in the manufacturing of the packaged drinking water, remineralization
may also be done. This process involves addition of ingredients. In case remineralization is carried
out by any manufacturer, ingredients used for the purpose shall be of food grade/pharmaceutical
grade quality.
Note: With respect to the conformity of ingredients used for remineralization to food
grade/pharmaceutical grade, original manufacturers declaration through labels or
certificate/test certificate from a BIS approved laboratory as per relevant Indian Standard or
IP/NFP/USP/BP requirements, in this respect will be accepted.
3.1.4 Processed water may be disinfected by means of chemical agents and/or physical methods to
control the micro-organisms to a level that does not compromise food safety or suitability for
consumption. Various means adopted for disinfection include ozonation, ultraviolet treatment,
silver ionization, etc. and/or combination thereof.
3.2

Packaged Natural Mineral Water

3.2.1 Packaged natural mineral water shall be water obtained directly from natural or drilled
sources from underground water-bearing strata.
3.2.2 Packaged natural mineral water is collected under conditions which guarantee the original
microbiological purity and chemical composition of essential components and subjected to
permitted treatments which include separation from unstable constituents, such as compounds
containing iron, manganese, sulphur or arsenic, by decantation and/or simple filtration, if necessary,
accelerated by previous aeration. No disinfection process is permitted.
Note: Only simple filtrations through filters of pore size not finer than 0.5 microns which do
not change the composition of the source water are permitted. Processes like reverse
osmosis, activated carbon bed filtration etc. are not permitted.
3.2.3 Packaged natural mineral water shall be packaged close to the point of emergence of the
source with particular hygienic precautions.
3.2.4 The transport of natural mineral water in bulk container is prohibited.
3.2.5 Natural mineral water shall have the constancy of its composition and the stability of its
discharge and temperature, due account being taken of the cycles of minor natural fluctuations.
Evidences for constancy of water composition at source on account of cycles of minor natural
fluctuations during different seasons in a year shall comprise of the following:
a)

Test report (from any BIS approved OSL) of all the major seasons covering major physicochemical parameters;

b)

Record of temperature at discharge point/ point of emergence (by manufacturer);

c)

The reports of all the seasons shall be reasonably comparable and conforming to IS 13428; and
6

d)

Report from the Hydrogeologist covering genesis of natural mineral water; period of its
residence in the ground; chemical, physical and radiological qualities; and the risk of pollution.

3.3 Packaging
3.3.1 The packaged water shall be packed in clean, hygienic, colourless, transparent, tamperproof
and sealed containers of various types/sizes/ made from plastic materials as permitted in either IS
13428 or IS 14543. Containers with features like Cool Jugs, Jugs with built-in taps, Jars with
threaded (reusable) caps without seal etc. shall not be permitted. Single-use disposable/collapsible
jars are also not permitted
3.3.2 There are many terminologies presently adopted by the industry and consumer for describing
the different packaging containers of packaged water. For the purpose of uniformity in describing the
various types of containers, descriptions as given in Table 1 have been derived. In case of change in
material (i.e., PET/PC) it shall be treated as separate type (ex. PET Jar,PC Jar).
Table 1: Description of Containers for Packaged Water
CONTAINER

DESCRIPTION

Jars

Reusable plastic containers with capacity above 5 litres

Plastic Bottles

One time use plastic containers with capacity upto and

including 5 litres.

Cup/Tumbler

One time use plastic container in cup shape or tumbler

(glass shape) with a peelable seal

Glass Bottle

Reusable containers made of glass material.

Pouches

Flexible Pouches made from plastic films.

3.3.3 The standards prescribe use of colourless and transparent containers. Therefore tinted
containers are not permitted.
Note: Use of HDPE containers had been discontinued after 31 July 2003, as communicated
by CMD-II vide note dated 01 08 2003 and 01 10 2003.
3.3.4 Cup/tumbler/pouch shall be filled with drinking water/natural mineral water followed by heat
sealing of cup/tumbler with peelable seal through automatic process. Manual filling and sealing shall
not be allowed so as to maintain hygiene and sanitation. Manual loading of packaging material
(cup/tumbler) may be accepted.
3.4 Assessment of Hygienic Conditions

Guidelines for assessment of hygienic conditions with explanatory notes have been given at Item 6
for the inspecting personnel.
4.

GRANT OF LICENCE

4.1

General

4.1.1. This section gives the guidelines on actions related to receiving of an application and its
processing for grant of licence (GOL). The pre-requisites for GOL shall be as per the requirements
published in BIS website, (www.bis.org.in) either for normal procedure or for simplified procedure.
4.1.2 Application for grant of licence for packaged water shall be accompanied by the list of
documents given in BIS Web site (www.bis.org.in). An application under simplified procedure shall
be accompanied with original test reports of PDW/PNMW as per relevant specifications and on
entire range of containers, their materials, caps and closures for which GOL has been requested.
4.2

Recording of Application

An application with its enclosures shall be scrutinized as per the check-list given in Annex 1.
Recording shall be done when all pre-requisites have been addressed in the application with
supporting documents.
4.3

Inspection

4.3.1 The format for Preliminary Inspection Report specific to PDW/PNMW shall be as given at
Annex 2, in case of application received under normal procedure.
4.3.2 The verification by BIS Inspecting Officer shall be reported in the format specific to
PDW/PNMW and as given at Annex 3, in case of application received under simplified procedure.
4.3.3

Aspects to be inspected

During preliminary inspection/verification visit, for assessing capabilities of the applicant

organization, with respect to manufacturing and testing facilities; competence of Quality Assurance
Personnel and hygienic conditions, following shall be verified:
a)

Correctness of documents and declarations submitted with the application and self evaluation
report (in case of application under simplified procedure);

b)
c)

Availability of all manufacturing facilities including filling and/or packaging machinery;

Process capability, starting with collection of raw water to packaged water including
intermediate checks;

d)

Filling and packing capabilities for all capacities and types of containers used in packaging
of water;

e)

Availability of required testing facilities, as per the relevant ISS. List of test equipment and
chemicals required for testing of packaged water is given at Annex 9.

f)

For testing certain requirements, as specified in the STI, the applicant may avail the
provision of STI for getting some tests done from outside BIS recognized laboratories
(OSL), if in-house facilities are not available. The applicant shall furnish an undertaking that
they shall get samples tested as per the frequency of STI at any BIS recognized laboratory
(test requirements which are to be conducted once in a month or beyond shall only be
permitted to be tested at OSL);

g)

Competence of Quality Assurance Personnel. There shall be at least two (2) Quality
Assurance Personnel, one of whom shall be a Chemist, the other a Microbiologist. For
further details, 4.7 shall be referred;

h)

Compliance to Hygienic Practices as per Annex B of IS 13428:2005 or Annex B of IS

14543:2004 ( Item 6 of this Manual);

i)

Availability of adequate storage facility for raw water, finished product and packaging
materials, keeping in view the installed capacity of the firm for packaging in 24 hours and
storage capacity of finished product for 48 hours;

j)

The correctness of plant layout with respect to following:

i) Source of raw water and raw water storage facility
ii) pipeline, storage tanks etc;
iii) Plant for the manufacture of PDW and/or PNMW, as the case may be (with various
process stages);
iv) Filling/packing/loading/ unloading areas;
v) Storages for packaging material and finished product

;
vi) Entry/exit with indications of double door/door closures/air curtains, wherever
provided;
vii) Laboratory;
viii) Actual boundary/perimeter of the establishment;
ix) change room, toilet(s), whether the premises also used for residential/other purposes,
with identified locations.
Note: A typical manufacturing process; process flow chart; CIP process for plant and
machinery and pipelines; and cleaning process for reusable jars are given at Annex 5.

4.3.4 Hygiene Practices

Hygienic practices in the plant shall be verified as per Annex B of IS 13428:2005 or Annex B of IS
14543:2004 ( Item 6 of this Manual and Annex 4). Explanatory notes provided at the end for
guidance only.
4.4

Sample for Independent Testing

4.4.1 Packaged Water (Packaged Drinking Water and/or Packaged Natural Mineral Water)
One sample of packaged water shall be drawn and sent for complete testing for all
of the relevant Indian Standard.

requirements

4.4.1.1 In case the applicant is adopting more than one type of processes/sources of raw water,
separate samples shall be drawn for each process/source.
4.4.1.2 In the event of more than one bore well /open well located in the same premises, they shall
be considered as a single source for the purpose of drawing of sample of PACKAGED DRINKING
WATER as well as for exercising quality control, provided there is only one processing line.
4.4.1.3 Samples shall be drawn in sealed containers only, which shall not be leaking. During
sampling, the container of packaged water sample shall never be opened for any purpose as the
water will get contaminated.
4.4.2

Packaging Material

4.4.2.1 When an application is received under normal procedure for GOL, during preliminary
inspection, along with one sample of packaged water, samples of all containers,( of each type, each
size and each material) and their material (for example, film with pouch) shall be drawn for
complete testing as per IS 15410 and/or IS 15609 as applicable and for which application has been
made to include in the licence
4.4.2.2 When an application has been received under simplified scheme, during verification
inspection by BIS officer before GOL, one sample (any one size, type and material) for one type of
container shall be drawn for complete testing as per IS 15410 and/or IS 15609 respectively..
4.4.3 Sample Size
4.4.3.1 Packaged Water
a)
For all parameters other than radio active residues - A sample containing approximately
18 litres of packaged water (PDW/PNMW) is adequate, if packed in 2 litres or smaller containers
but in case the samples are available in large size packages, minimum two such packages are

10

required as microbiological laboratory needs separate sample for ensuring aseptic handling. For
example:
Capacity
of
bottle/Jar in litres
1
2
5
10
20
24

Numbers
to
be
drawn
18
9
4
2
2
2

Pouches: 2 bags of 100 pouches each + Film. A sample of 4 bags shall be drawn in case
each bag contains 50/60 pouches.
b)

For Parameters concerning Radio-active Residue

In addition to the above, sample shall also be drawn for testing parameters concerning radio active
residues. A sample of 10 litres is adequate.
Note: If a fresh application has been submitted after closure of earlier application or
expiry/cancellation of earlier licence and the closure of application/licence was for reasons
other than failure in radioactive residues, fresh sample of water need not be drawn for testing
of radioactive residues, if evidence is available that the source of raw water remained the
same as that in earlier application/licence, provided that radioactive residue TR of the sample
drawn by BIS during verification visit passes and is not older than two years. The earlier test
reports of sample drawn by BIS (not older than two years) shall be accepted within a period
of two years.
4.4.3.2 Sample of packaging material (containers)
PET Bottles upto 2 litres 18 Empty (with caps) + 12 filled
5 litres 12 Empty (with caps) + 9 filled
10 litres & above 6 Empty (with caps) + 3 filled
Pouches: 4 bags of 50/100 pouches each + one meter film used for making the pouches. Cup/Glass
along with peelable seal: 25 Empty + 25 filled + lids (25)
Note 1: The pouches shall be made in the presence of BIS officer, during inspection, and
may be printed with only details like batch number, date of manufacturing, best before date,
capacity, using ink to be used by the manufacturer for marking on the pouches. This will
facilitate testing of pouches for ink adhesion test and product resistance test. This is being
allowed as manufacturer can not get the pouch film rolls printed with all other details such as
Standard Mark etc. before the GOL.

11

Note 2: As there is presently no Indian Standard for glass bottle/tumbler, such containers
need not be tested. However, if any manufacturer intends to use such container, it shall be
included in the licence.
4.4.4

Samples shall not be drawn for independent testing for the following:
a) Product Durability Assessment (shelf life study), and
b) Raw Water Requirements

4.5

Test Request and Selection of Laboratory

4.5.1 Masking of sample

Effort shall be made, as far as possible, to send samples without the manufacturers identification
and/or markings. Any label and/or manufacturer's identification from the bottles/Jars shall be
removed or defaced.
4.5.2 Test request
Test request shall clearly indicate the following:
a) Date of processing/packing;
b) Best Before Date;
c) Quantity (in litre or milliliter),
d) Type, material and capacity of container
e) Declared wall thickness of container(s)/width of film of pouch
4.5.3 Selection of laboratory for independent testing:
Samples shall be tested either at a BIS laboratory or BIS recognized laboratory .List of recognized
laboratories is given on BIS website. Selection of laboratory for independent testing shall be as per
provisions of OMPC.
4.6 Verification of Calibration of Test Equipment
4.6.1
Records of calibration of test equipment need to be maintained by the applicant.
Although the test equipment will depend upon the selection of test method by the applicant from the
options available in the respective Indian Standard, calibration of following test equipment is
considered necessary at least once a year. The calibration certificates shall be from NABL
accredited laboratory or from laboratory having traceability to national level.

12

a) Analytical balance (electronic)/weight box (including fractional weights),

b) Temperature indicators of all incubators,
c) Pressure gauge of Autoclave, and
d) Temperature indicator of Autoclave (optional)
4.6.2 Other instruments, such as spectrophotometer, turbidity meter, pH meter are
standardized as per the standard operating procedures supplied with respective instrument.
4.7

to be

Quality Assurance Personnel

4.7.1 There shall be minimum two Quality Assurance Personnel, one for carrying out chemical
testing and the other for microbiological testing.
4.7.2 The personnel for chemical testing shall be minimum science graduate with chemistry as one
of the subjects. Microbiologist shall be a science graduate with preferably Botany or Microbiology
as a subject or a graduate in Food Technology/science or Dairy Technology/science or Agriculture.
Both shall have necessary competence to carry out testing of the respective tests (chemical or
microbiological).
4.7.3 The IO shall witness all possible tests that can be conducted during the inspection. For those
tests which are not possible to be carried out during inspection, assessment of competence may be
made through interview of the testing personnel, demonstration of initiation of tests, equipment,
interpretation of results etc., which shall be suitably recorded in IR.
4.8

STI

Acceptance of existing scheme of testing and inspection (STI) shall be obtained from the applicant
during the inspection visit, if the same has not been received earlier.
4.9

Marking Fee

Acceptance of existing rate of marking fee shall be obtained from the applicant during the inspection
visit, if the same has not been received earlier.
4.10

Processing for Grant of Licence

The Red Form shall be put up as per the check-list given in Annex 6 with all attached documents
serially page-numbered. In case of GOL under normal procedure, if the product water is conforming
and failure(s) of Container samples are reported, grant of licence shall be processed for the product
water as per IS 14543/IS 13428, as the case may be along with the remaining container(s) which
have been reported as passing.
Note 1 under 2.9.1 of OMPC is not applicable in such cases.
13

4.11

Scope of Licence

Licence shall be granted with scope specifying the type(s) and material(s) of container(s) permitted
to be used for packing the product. Licence shall not be granted with open scope. A container
shall be included in the licence subject to availability of proof of conformity to the relevant Indian
Standard for each of such container(s). The grant of licence letter and the Licence Document shall
clearly indicate the following:
a)

Packaged Natural Mineral Water/ Packaged Drinking Water with corresponding Indian
Standard;

b)

Type of each container (Jar, Bottle, Cup/Tumbler, Pouch);

c)

Material of construction of each container (PC/PET/PP/PS/PE/Glass);and

d)

Size/Capacity of the container.

(see Clause 3.3.2 for Guidelines for above classification)

OPERATION OF LICENCE

5.1

General

This section provides guidelines for operation of licence based on IS 13428 or IS 14543 and the
corresponding Scheme of Testing and Inspection. The operational guidelines as given under
Operating Manual for Product Certification shall be followed for those situations that are not
specifically covered in this Manual.
5.2

Periodic (Surveillance) Inspection

At least two surveillance inspections are required to be done in an operative year of a licence, as per
the requirements of the BIS (Certification) Regulations, 1988. The inspections shall be planned in a
manner to evenly spread over during the period of a licences validity. A surveillance inspection
shall not be done after validity of a licence is over and decision is pending for its renewal. The report
of surveillance Inspection of a packaged water licensee shall be submitted as per the format given at
Annex 7 along with Hygiene Checklist as given at Annex 8.
5.2.1 Scheme of testing & inspection(STI)
The STIs for IS 13428 and 14543 as in force shall be applicable. The implementation of STI shall be
verified during surveillance inspection.
5.2.2 Marking fee
The details of rate of marking fee are available on BIS intranet/website.
14

5.2.3 List of laboratories for independent testing

The list of BIS laboratories and laboratories recognized by BIS, where sample of packaged water
and/or its container can be sent for independent testing, are available on BIS intranet/website. The
inspecting officer/agent shall collect latest status in respect of any laboratory before proceeding for
inspection.
5.2.4 Sample from factory and market
Sample of packaged water shall be drawn during surveillance inspection from the available stock or
from production with Standard Mark observed during such inspection (FS). Two FS shall be drawn
and independently tested during an operative period of a licence (drawing one sample during one
inspection). Four market samples (MS) of packaged water shall also be drawn during an operative
year of the licence. Samples of containers and packaging materials are also required to be drawn for
testing by rotation pertaining to various containers as permitted in the licence as it is essential to
monitor the quality of container(s) being used for filling with packaged water. The details of
samples that should be drawn in one operative year of a licence are given in Table 2 and Table 3:
Table 2 - Sampling from Factory during surveillance inspection
Particulars of
sample

No.
of
sample(s)

Details of tests to be conducted

FS

During the operative period, at least one

FS/MS shall be tested for all requirements
including pesticide residues.
Note: One FS shall be tested every two
(2) years for parameters concerning
radio-active residues. If FS could not be
drawn for testing for Radioactive residues
due to any reason then, MS shall be tested
for the same

Container

From the first periodic inspection

/surveillance visit (verification visit by
BIS in case of GOL under simplified
procedure) onwards, one sample of any
one type of container ( one size and
material) shall be tested once a year for all
requirements of relevant Indian Standard.
Sampling of container shall be done in a
manner so as to cover all type, sizes &
15

material on rotational basis during the

operation of the licence. Sample of
container shall be drawn at the same time
when a FS is being drawn.
Table 3 - Sampling from Market
Particulars of
sample
MS

5.3

No.
of
sample(s)
4

Details of tests to be conducted

All 4 MS shall be tested for all
requirements of the Indian Standard,
except for pesticides residues and
parameters
concerning
radio-active
residues. Also refer Table 2 above for FS

Hygienic Conditions

Plant, process and personnel hygiene shall be assessed during every surveillance inspection as per
Hygienic Practices at Annex B of IS 14543:2004 or Annex B of IS 13428:2005 (Item 6 of this
Manual). The filled up Checklist (Annex 8 of this Manual) also shall be attached with Surveillance
Inspection Report.
5.4

Operational Issues

5.4.1

Change of source of raw water or change in process

5.4.1.1 Packaged natural mineral water

In case of change of source of raw water by the licensee, documentary evidence shall be collected as
stated under 3.2.5 of this Manual and examined vis--vis the requirements of IS 13428 for constancy
of source water quality. An inspection shall be carried out to verify that the restrictions specified in
the standard with respect to processing and disinfection are complied; to verify plant machinery and
to check hygienic conditions. A sample of packaged natural mineral water produced by using
changed source shall then be drawn for independent testing for its conformity to all requirements of
the standard including parameters concerning radio-active residues. CM/PF 305 shall be submitted
by the licensee and countersigned by the inspecting official after due verification of declarations
made therein. Permission for use of Standard Mark shall be given on receipt of test reports
indicating conformity of the sample.
5.4.1.2 Packaged Drinking Water
In case of change of source of raw water by the licensee, an inspection shall be carried out to verify
the changes made in processing of raw water, if any; to verify plant machinery and to check
hygienic conditions. CM/PF 305 shall be prepared by the licensee and countersigned by the
inspecting official after due verification of details. A sample of packaged drinking water produced
16

by using changed source shall then be drawn for independent testing for its conformity to all
requirements of the standard including parameters concerning radio-active residues. Permission for
use of Standard Mark shall be given on receipt of test reports indicating conformity of the sample.
Clause 4.4.1.2 of this manual may also be referred.
5.4.1.3 Concurrent use of raw water from two different sources
In case of concurrent use of raw water of two different types of sources (for example water being
extracted through own bore-well and also obtained from municipal source), the production from
each source shall be assigned a different batch number and separately tested as per STI for
conformity of the product water, provided production lines are separate. Accordingly, records of
production and testing of packaged drinking water produced using both the sources shall be kept by
the licensee. However, when there is more than one source of raw water but processing plant is one,
testing of packaged drinking water shall be done after duly verifying the additional source(s) being
introduced and appropriate record in CM/PF 305, if necessary shall be made. Such testing shall
include parameters concerning radio-active residues.
5.4.2 Change in the process
In case of any addition, alteration and/or change in the production process without any change in
raw water source (for example, remineralization has been added after reverse osmosis in production
of packaged drinking water or decantation has been introduced as a process step in production of
packaged natural mineral water), necessary verification of plant and machinery shall be done with
duly filling up of CM/PF 305. A sample is required to be drawn for independent testing for its
conformity to the relevant Indian Standard, except for parameters concerning radio-active residues,
before permitting the same to be marked. Testing of product water so produced by using different
processes shall be carried out as per STI and records be kept separately by the licensee.
Note 1: Testing for parameters concerning radio-active residues need not be done
under above circumstances provided the source of raw water remains the same.
Note 2: Any change in process may require fresh approval of label. Therefore
licensee shall be advised to prepare fresh label incorporating all marking details and
obtain approval.
5.4.3 Shelf-life
The shelf-life of packaged natural mineral water/packaged drinking water shall be minimum
30 days. If the manufacturer intends to declare a longer shelf-life than minimum 30 days,
study shall be conducted on each type of packing at least once a year or whenever there is a
change in the source of raw water/manufacturing/packing process, whichever is earlier. The
shelf-life period shall be declared on the labels suitably as Best for consumption within ----days or -----months from the date of packing based on the shelf life studies (but not less
than 30 days). Subsequently, for any change in the shelf life declared on the labels, the
manufacturer shall inform BIS in advance along with shelf- life study reports and submit
fresh label for approval. Tests to be carried out for shelf life studies are requirements given
17

in Table 1 of IS 14543/IS13428 along with routine microbiological tests as per IS

14543/IS13428.
5.4.4 Change in the scope of licence
5.4.4.1 Extension of scope
There are many instances when licensees request for permitting use of additional types of
packaging materials/filling capacities, although basically the packaged water may remain
the same (i.e., other than those related to remineralization). These may be considered based
on the following:
Under Normal Procedure
a)

Packing/filling/cleaning and disinfection (in case of reusable containers) arrangements

related to proposed inclusion such as required infrastructure, filling facilities, flow
process and intermediate checks etc., are verified and recorded on CM/PF305;

b)

Associated hygienic conditions are verified, if applicable;

c)

Raw water shall not be tested;

d)

Sample for shelf-life test shall not be drawn. Only declaration in this regard shall be
obtained; and

e)

Sampling of container for independent testing should be done as follows:

Irrespective of whether, the test certificate of containers with respect to conformity to IS 15410 or
15609, as applicable, is available or not, sample of each type/ size/material shall be drawn for
complete testing. Endorsement to the licence shall be issued for including the particular type of
container in the licence after sample of such container is found conforming to the standard.
Under Simplified Procedure
For inclusion under the simplified procedure, in case the licensee submits the complete test report of
containers from OSL along with modified process flow chart if any, additional infrastructure
facilities if required, intermediate checks etc., inclusion as per the simplified procedure shall be
permitted without any further testing. The variety so included may be drawn for independent testing
during subsequent visits on rotational basis, so as to cover the entire range and the changes intimated
shall be verified during the subsequent visit.
The licensee shall submit an undertaking that in case of failure of sample in independent testing, he
shall abide by the instructions of BIS for stop marking/withdrawal of permission to use the particular
type of container/cancellation of licence, as the case may be.
5.5

Stop Marking - Resumption of Marking

18

The procedure given in OMPC shall be followed.

5.6 Handling Complaints on Packaged Water
5.6.1 As the packaged water is meant for mass consumption and also related directly to the health
and safety of the consumer, it is quite likely that complaints may arise for the same. The product is
not expensive. Therefore, as per the OMPC a replacement can straight away be arranged to the
complainant. However, the following aspects need to be addressed suitably.
5.6.2 Redressal to the complainant may be arranged either from the existing stock (if declared to be
conforming) or from the fresh production after resumption of marking is permitted to the licensee (in
case Firm is under stop marking for any reason or has been placed under stop marking due to
complaint or any other reason).
5.6.3 If it is not possible to establish the complaint by visual examination, it would be necessary to
send material under complaint for independent testing. However, if the container has already been
opened and the packaged water is not available in originally packed condition, it shall not be sent for
testing. Only unopened sealed container (packing with intact cap/closure/seal) shall be sent for tests.
Attempts may be made to procure material pertaining to the same lot/batch/manufacturing date from
the market, if available and sent for independent testing to establish the complaint. However, such
sample purchased from the market shall not have the status of complaint sample but would only be
treated as a market sample and would be handled in the manner in which any other market sample is
handled.
5.6.4 The above procedure is to be followed in addition to the procedure of handling of complaints
as given in the OMPC.
6

GUIDELINES FOR ASSESSMENT OF HYGIENIC CONDITIONS IN PACKAGED

DRINKING WATER UNIT WITH EXPLANATORY NOTE (BASED ON IS 14543:2004)

REQUIREMENT
OF
INDIAN EXPLANATORY
NOTES
FOR
STANDARD
GUIDANCE
B-1 FIELD OF APPLICATION
The hygienic practices cover the appropriate
general techniques for collecting drinking
water, its treatment, bottling, packaging,
storage, transport, distribution and sale for
direct consumption, so as to guarantee a
safe healthy and whole some product.
B-2 HYGIENE PRESCRIPTIONS FOR COLLECTION OF DRINKING WATER
It may be ensured that the ground water source
B-2.1 Extraction or Collection
is reasonably away from any polluting source
In the case of extraction or collection of like drain/ sewer/ septic tank.
water intended for packaging from ground
water sources, it should be ensured that it is Ground water source (whether owned/ shared)
safe from pollution, whether caused by shall be under the direct control and supervision
19

natural occurrence or actions or neglect or of the manufacturer. Clear declaration from the
ill-will.
manufacturer for ensuring that the ground water
source is safe from pollution either by natural
occurrence or because of action/ neglect/ ill-will
shall be taken.
B-2.2 If water to be processed for packing is
obtained from any other potable source it
should
be
protected
from
being
contaminated.
B-2.3 The firms using waters from drinking
water systems intended for packaging
should ensure that it meets the requirements
of the standard.
The material should preferably be of stainless
B-2.4 Materials
The pipes, pumps or other possible devices steel. However, GI or plastic material may also
coming into contact with water and used for be used. In case of plastic materials, it should
its collection should be made of such be supported with certificate for its food-grade
material that they do not change the quality quality. Rubber pipe shall not be permitted.
of water.
B-3 PROTECTIVE MEASURES
B-3.1 All possible precautions should be The surrounding of the source water outlet
taken within the protected perimeter to should be completely covered with pucca
avoid any pollution of, or external influence construction to avoid contamination due to
on, the quality of the ground or surface ingress of external causes. If it is at ground
water. Preventive measures should be taken level then it should be covered with a boundary
for disposal of liquid, solid or gaseous waste wall upto an adequate height.
that could pollute the ground or surface
water. Drinking water resources should not
be in the path of potential source of
underground contamination.
B-3.2 Protection of the Area of Origin
The immediate surroundings of the Outlets of bore well/ well heads should be
extraction or collection area should be covered and locked.
protected by limiting access to authorized Units should prevent entries of individuals,
persons only.
Wellheads and spring pests and other sources of extraneous matter to
outflows should be protected by a suitable the immediate surroundings of source of water.
structure to prevent entry by unauthorized
individuals, pests and other sources of
extraneous matter.
B-4 TRANSPORT OF DRINKING WATER
B-4.1 Means of Transport, Piping and Water from the source to processing unit may
be transported through pipes.
Reservoirs
Any vehicle, piping or reservoir used in the Piping used should preferably be of SS.
processing of water from its source to the However, food grade plastics or GI may also be
bottling facilities, should be made of inert permitted. Rubber pipe should not be permitted.
material such as ceramic and stainless steel Reservoir should preferably be of SS. In case
20

which prevent any deterioration, be it by of plastic reservoir, inside layer should be of

water,
handling,
servicing
or
by food grade plastic (certificate may be
disinfection; it should allow easy cleaning.
collected).
Cemented
(underground/
overground) reservoir should be properly tiled
from inside.
B-4.2 Maintenance of Vehicles and The design of reservoir should be such as to
enable easy cleaning or disinfection and it
Reservoirs
Any vehicle or reservoir should be properly should be properly maintained throughout the
cleaned and, if necessary, disinfected and operation of licence.
kept in good repair so as not to present any
danger of contamination to drinking water
and of deterioration of its quality.
B-5 ESTABLISHMENT FOR PROCESSING OF DRINKING WATER DESIGN AND
FACILITIES
The unit should not be in low lying area to
B-5.1 Location
Establishments should be located in areas avoid collection of dust, contaminant, rain and
which are free from objectionable odours, flood water.
smoke, dust or other contaminants and are Factories in open area/ field should have its
not subject to flooding.
proper boundaries with controlled access.
B-5.2 Roadways and Areas Used by Areas in front of main entry to the unit and
immediate surroundings should be paved
Wheeled Traffic
Such roadways and areas serving the (pucca) or properly grassed to prevent dust
establishment which are within its contamination due to vehicular traffic.
boundaries or in its immediate vicinity
should have a hard paved surface suitable
for wheeled traffic.
There should be
adequate drainage and provision should be
made for protection of the extraction area.
B-5.3 Buildings and Facilities
Buildings should be sound pucca construction,
B-5.3.1 Type of construction
Buildings and facilities should be of sound preferably plastered and properly painted/ white
construction and maintained in good repair. washed. Internal partitions made of plastic may
be accepted.
The manufacturing area should not be permitted
B-5.3.2 Disposition of Holding Facilities
Rooms for recreation, for storing or for general residence or recreation purposes.
packaging of water and areas for cleaning of In case of any duty quarters for workers/
containers to be reused should be apart from residential area, the same should be reasonably
the bottling areas to prevent the end away from the plant and clearly demarcated and
products from being contaminated. Raw maintained.
materials and packaging materials and any Area for cleaning of reusable containers,
other materials which come into contact packaging material and storage of finished
with drinking water should be stored apart water should be separate from processing/
from other material.
filling area. All types of packaging materials
should be stored in a separate room/ area.
B-5.3.3 Adequate working space should be Sufficient space should be available for easy
provided to allow for satisfactory movement
in different
operations of
21

performance of all operations.

B-5.3.4 The design should be such as to
permit easy and adequate cleaning and to
facilitate proper supervision of hygiene for
drinking water.
B-5.3.5 The buildings and facilities should
be designed to provide separation by
partition, location or other effective means
between those operations which may cause
cross-contamination.

manufacturing.

There should not be any other activity except

production and packing of water. In case
similar products like cold drink/ beverages/
soda are also manufactured in the same
premises, these activities should be clearly and
entirely separated from water manufacturing
and packing facilities. However, for such food
items manufacturing, use of processed water
through a separate pipe line and separate plant
and machinery may be permitted.
There should be proper separation between
different processing activities like blowing of
bottles/ storage of containers: cleaning of
reusable containers: raw water storage tank:
filtration (ROs/Micron) disinfection and filling.
Exhaust of laboratory should not open in
processing/ filling area.
B-5.3.6 Buildings and facilities should be As far as possible the flow of air should be from
designed to facilitate hygienic operations by filling room to the outer area and not the other
means of a regulated flow in the process way round.
from the arrival of the drinking water at the
premises to the finished product, and should
provide for appropriate conditions for the
process and the product.
B-5.3.7 Drinking Water Handling, Storing and Bottling Areas
The flooring should be smooth, without any
B-5.3.7.1 Floors
Where appropriate, should be of water- cracks/ broken surfaces.
Joints shall be
proof, non-absorbent, washable, non-slip properly filled and smooth. The slope of the
and non-toxic materials, without crevices, flooring in processing and filling area should be
and should be easy to clean and disinfect. such as to avoid any stagnation of water. The
Where appropriate, floors should have inside drains, if kept open, should be properly
sufficient slope for liquids to drain to tiled for easy and effective cleaning. Drains
trapped outlet.
should always be in clean condition and
provided with traps to prevent the entries of
rats/ pests.
In case of cemented walls, tiles upto height of
B-5.3.7.2 Walls
Where appropriate, should be of water about 5 to 8 feet from floor level should be
proof, non-absorbent, washable and non- provided.
Wall made of smooth plastic
toxic materials and should be light coloured. material may be accepted.
Up to a height appropriate for the operation
they should be smooth and without crevices,
22

and should be easy to clean and disinfect.

Where appropriate, angles between walls,
between walls and floors and between walls
and ceilings should be sealed and smoothen
to facilitate cleaning.
B-5.3.7.3 Ceilings
Should be so designed, constructed and
finished as to prevent the accumulation of
dirt and minimize, condensation, mould
growth and flaking, and should be easy to
clean.
B-5.3.7.4 Windows
Windows and other openings should be so
constructed as to avoid accumulation of dirt
and those which open should be fitted with
screens. Screens should be easily movable
and cleaning and kept in good repair.
Internal window sills should be sloped to
prevent use as shelves.
B-5.3.7.5 Doors
Should have smooth, non-absorbent
surfaces and, where appropriate, be selfclosing and close fitting type.

Ceiling should preferably be pucca cemented

and smooth. However, factories with tin/
aluminum/ asbestos shed should have proper
smooth false ceiling made of non absorbent
material (like plastic).
Wood or similar
material should not be used as it may attract
fungal/ mould growth.
Open windows should not be permitted.
Windows shall be provided with net screens
which are easily cleanable and moveable.
Fittings shall be so intact as to prevent entry of
mosquitoes/ flies.

Each door should have door closure. Air

curtains should preferably be provided at
different entries including all inlets and outlets
of filling room. The surface of doors should be
of non absorbent material.
B-5.3.7.6 Stairs, lift cages and auxiliary All stairs, lifts, chutes and ladders should be of
sound construction and properly painted.
structures
Platforms, ladders, chutes, should be so
situated and constructed as not to cause
contamination to drinking water. Chutes
should be constructed with provision of
inspection and cleaning hatches.
Different colour coding should be provided so
B-5.3.7.7 Piping
Piping for drinking water lines should be as to easily distinguish between different pipe
independent of non-potable water.
lines. The pipe line meant for potable water
should preferably be green in colour. The
entire pipe line for production water including
joints after RO shall be made of stainless steel.
The joints should preferably be of dairy fitting
type.
B-5.3.8 In drinking water handling areas all In case false ceiling is provided, care should be
overhead structures and fittings should be taken to periodically clean the same and it
installed in such a manner as to avoid should be ensured that ceiling is perfect
contamination directly or indirectly of (without any breakage/ seepage) at all times.
drinking water and raw materials by
condensation and drip and should not
23

hamper cleaning operations. They should

be insulated where appropriate and be so
designed and finished as to prevent the
accumulation of dirt and to minimize
condensation, mould growth and flaking.
They should be easy to clean.
B-5.3.9 Living quarters, toilets and areas
where animals are kept should be
completely separated and should not open
directly on to drinking water handling areas.
B-5.3.10
Where
appropriate,
establishments should be so designed that
access can be controlled.
B-5.3.11 The use of material which cannot
be adequately cleaned and disinfected, such
as, wood, should be avoided unless its use
would not be a source of contamination.
B-5.3.12 Canalization, Drainage Lines
Canalization and drainage and used water
lines should be built and maintained in such
a manner as not to present any risk
whatsoever of polluting the underground
water source. .

Entry to different water processing area should

be controlled in such a way that only the
authorized persons have the access.
Wood in any form should not be used in
processing and filling area.

The drainage line of plant should have proper

slope and should be made of material which
facilitate easy cleaning. There should not be
any stagnation of water/ effluent.
The main drainage line of the plant should be of
sound structure, fully covered and should open
outside the plant only, away from underground
water source.

B-5.3.13 Fuel Storage Area

Any storage area for the storing of fuels,
such as, coal or hydrocarbons should be
designed,
protected,
controlled
and
maintained in such a manner as not to
present a risk of pollution during the storage
and manipulation of these fuels.
B-5.4 Hygienic Facilities
B-5.4.1 Water Supply
B-5.4.1.1 Ample supply of potable water
under adequate pressure and of suitable
temperature should be available with
adequate facilities for its storage, where
necessary, and distribution with adequate
protection against contamination.
The
potable water should conform to IS 10500.

Conformity of raw water is for guidance only.

It should be ensured that the source of raw
water (potable) remains uniform. The use of
raw water from different sources shall not be
done unless permitted (see Section 5 of the
manual). However in case of change of source,
provisions of STI shall be followed.
In order to monitor the uniform supply of raw
water, testing of the same should be carried out
as per the frequency prescribed in STI and
records be maintained.
B-5.4.1.2 Potable water, non-potable water See Explanatory notes against Cl. B-5.3.7.7
24

for steam production or for refrigeration or

for any other use should be carried in
separate lines with no cross connection
between them and without any chance of
back siphonage. It would be desirable that
these lines be identified by different
colours.
B-5.4.2 Effluent and Waste Disposal
Establishments should have an efficient
effluent and waste disposal system which
should at all times be maintained in good
order and repair.
All effluent lines
(including sewer system) should be large
enough to carry the full loads and should be
so constructed as to avoid contamination of
potable water supplies.
B-5.4.3 Changing Facilities and Toilets
Adequate, suitable and conveniently located
changing facilities and toilets should be
provided in all establishments. Toilets
should be so designed as to ensure hygienic
removal of waste matter. These areas
should be well lighted, ventilated and
should not open directly on to drinking
water handling areas.
Hand washing
facilities with warm or hot and cold water, a
suitable hand-cleaning preparation, and with
suitable hygienic means of drying hands,
should be provided adjacent to toilets and in
such a position that the employee will have
to use them when returning to the
processing area. Where hot and cold water
are available mixing taps should be
provided. Where paper towels are used, a
sufficient number of dispensers and
receptacles should be provided near each
washing facility. Care should be taken that
these receptacles for used paper towels are
regularly emptied. Taps of a non-hand
operatable type are desirable.
Notices
should be posted directing personnel to
wash their hands after using the toilets.
B-5.4.4 Hand Washing Facilities in
Processing Area
Adequate and conveniently located facilities
for hand washing and drying should be

Pipe line carrying the effluent and waste should

preferably be of red in colour.

Entrance to the production unit should be

through change room.
Change room should have hand washing
facilities (with hot and cold water) wash basin,
foot cleaning and drying facilities. Protective
clothing, footwear and head gear should be
changed inside the change room only. The
protective clothings should be taken out as and
when workers go out of the production hall, so
as to prevent any contamination of the same.
Toilets should be provided for workers and
should always be kept clean. These should be
properly separated from water handling areas.
Toilets should be made of pucca structured
preferably tiled with proper doors and water
facilities. Hand and foot washing facilities
should be provided adjacent to toilets.
Notices giving instructions for hand and foot
washing after using toilets (in local languages)
should be pasted at proper places.

See explanatory notes against Cl. No. B-5.4.3

25

provided wherever the process demands.

Where appropriate facilities for hand
disinfection should also be provided.
Warm or hot and cold water should be
available and taps for mixing the two should
be provided. There should be suitable
hygienic means of drying hands. Where
paper towels are used, a sufficient number
of dispensers and receptacles should be
provided adjacent to each washing facility.
Taps of a non-hand operatable type are
desirable. The facilities should be furnished
with properly trapped waste pipes leading to
drains.
B-5.4.5 Disinfection Facilities
Where appropriate, adequate facilities for
cleaning and disinfection of equipment
should be provided. These facilities should
be constructed of corrosion resistant
materials, capable of being easily cleaned,
and should be fitted with suitable means of
supplying hot and cold water in sufficient
quantities.
B-5.4.6 Lighting
Adequate lighting should be provided
throughout the establishment.
Where
appropriate, the lighting should not alter
colours and the intensity should not be less
than:
540 lux (50 foot candles) at all inspection
points,
220 lux (20 foot candles) in work rooms,
and
110 lux (10 foot candles) in other areas.
Suspended light bulbs and fixtures in any
stage of production should be of a safer type
and protected to prevent contamination of
drinking water in case of breakage.
B-5.4.7 Ventilation
Adequate ventilation should be provided to
prevent excessive heat, steam condensation
and dust and to remove contaminated air.
The direction of the air flow should never
be from a dirty area to a clean area.
Ventilation openings should be provided
with a screen or other protecting enclosure

Disinfection of pipe lines and process

equipments should preferably be done before
commencement of production.

Intensity of light is given only for guidance.

However the IO should judge the adequacy of
light intensity required for carrying out various
activities.
Suspended light bulbs and fixtures should be
protected by providing suitable covers.

Exhaust openings should be covered with

wiremesh or with suitable flaps. Air curtains
should be fitted in such a way that air should
not flow towards water filling room/ area.

26

of non-corrodible material. Screens should

be easily removable for cleaning.
B-5.4.8 Facilities for Storage of Waste Facilities for storage of waste and inedible
material should be outside the processing plant
and Inedible Material
Facilities should be provided for the storage and finished product storage area.
of waste and inedible material prior to
removal from the establishment. These
facilities should be designed to prevent
access to waste or inedible material by pests
and to avoid contamination of drinking
water; equipment, buildings or roadways on
the premises.
B-5.5 Equipments and Utensils
B-5.5.1 Materials
All equipment and utensils used in drinking
water handling areas and which may contact
the drinking water should be made of
material which does not transmit toxic
substances, odour or taste, is non-absorbent,
is resistant to corrosion and is capable of
withstanding repeated cleaning and
disinfection. Surfaces should be smooth
and free from pits and crevices. The use of
wood and other materials which cannot be
adequately cleaned and disinfected should
be avoided except when their use would not
be a source of contamination.
B-5.5.2. Hygienic Design, Construction and Installation
B-5.5.2.1 All equipment and utensils should
be so designed and constructed as to prevent
hazards and permit easy and thorough
cleaning and disinfection.
B-6 ESTABLISHMENT
B-6.1 Maintenance
The buildings, equipments, utensils and all
other
physical
facilities
of
the
establishment, including drains, should be
maintained in good repair and in an orderly
condition.
B-6.2 Cleaning and Disinfection
B-6.2.1 To prevent contamination of All equipments and utensils should be cleaned
drinking water, all equipment and utensils and preferably disinfected, every day before
should be cleaned as frequently as necessary commencement of production.
and disinfected whenever circumstances
demand.
B-6.2.2 Adequate precautions should be See explanatory note as given in B-5.4.5
27

taken to prevent drinking water from being

contaminated
during
cleaning
or
disinfection of rooms, equipment or
utensils, by wash water and detergents or by
disinfectants
and
their
solutions.
Detergents and disinfectants should be
suitable for the purpose intended. Any
residues of these agents on a surface which
with may come in contact with drinking
water should be removed by thorough
rinsing with water, before the area or
equipment is again used for handling
drinking water.
B-6.2.3 Either immediately after cessation
of work for the day or at such other times as
may be appropriate, floors, including drains,
auxiliary structures and walls of water
handling areas should be thoroughly
cleaned.
B-6.2.4 Changing facilities and toilets Changing facilities like aprons, headgears,
should be kept clean at all times
mask etc. should be available in sufficient
numbers to meet daily and contingency
requirement.
B-6.2.5 Roadways and yards in the The area surrounding the unit may be grassed to
immediate vicinity of and serving the prevent entry of dirt and dust in the plant.
premises should be kept clean.
Construction of wall of adequate height
(approximate 8 feet) is required when the
immediate surrounding is not in the control of
the unit.
B-6.3 Hygiene Control Programme
A permanent cleaning and disinfection The hygiene control programme should cover
should be drawn up for establishment to all aspects.
ensure that all areas are appropriately An elaborate hygiene control plan should be
cleaned and that critical areas, equipment drawn for monitoring the hygienic conditions of
and material are designated for special the plant and personnel. The plan should
attention.
An individual, who should invariably include the following:
preferably be a permanent member of the Hygiene requirement
staff of the establishment and whose duties Frequency
should be independent of production, should Name of the person directly responsible for
be appointed to be responsible for the supervision
cleanliness of the establishment. He should The above plan should be monitored by a
have a thorough understanding of the designated person who has thorough
significance of contamination and the understanding of significance of contaminants
hazards involved. All cleaning personnel and hazards.
should be well-trained in cleaning The hygiene control schedule should be
techniques.
properly displayed at different points like
28

processing/ filling/ storage.

B-6.4 Storage and Disposal of Waste
Waste material should be handled in such a
manner as to avoid contamination of
drinking water. Care should be taken to
prevent access to waste by pests. Waste
should be removed from the water handling
and other working areas as often as
necessary and at least daily. Immediately
after disposal of the waste, receptacles used
for storage and any equipment which has
come into contact with the waste should be
cleaned and disinfected. The waste storage
area should also be cleaned and disinfected.
B-6.5 Exclusion of Animals
Animals that are uncontrolled or that could
be a hazard to health should be excluded
from establishments.

B-6.6 Pest Control

B-6.6.1 There should be an effective and
continuous programme for the control of
pests. Establishments and surrounding area
should be regularly examined for evidence
of infestation.
B-6.6.2 If pests gain entrance to the
establishment, eradication measures should
be instituted. Control measures involving
treatment with chemical, physical or
biological agents should only be undertaken
by or under direct supervision of personnel
who have a thorough understanding of the
potential hazards to health resulting from
the use of these agents, including those
hazards which may arise from residues
retained in the drinking water.
B-6.6.3 Pesticides should only be used if
other precautionary measures cannot be
used effectively. Before pesticides are
applied, care should be taken to safeguard
drinking water, equipment and utensils from
contamination.
After
application,
contaminated equipment and utensils should
be thoroughly cleaned to remove residues
prior to be used again.

See explanatory notes as given in Cl. B-5.4.2

No animal should be allowed inside the plant

area. If any stray intrusion of pest like lizard,
flies are found, immediate action shall be taken
to remove them and further necessary
preventive measures shall be taken.
Pest control measures should preferably be got
done through professional agencies with clear
indication of validity period, through a
certificate for the same. Fly catchers should be
provided in processing/ filling area.
Pesticides designated safe for use in food
industry should only be used under direct
supervision of trained personnel.

See explanatory note as given in Cl. B6.6.2

29

B-6.7 Storage of Hazardous Substances

B-6.7.1 Pesticides or other substances
which may present a hazard to health should
be suitably labeled with a warning about
their toxicity and use. They should be
stored in locked rooms or cabinets, and
dispersed and handled only by authorized
and properly trained personnel or by
persons under strict supervision of trained
personnel. Extreme care should be taken to
avoid contamination.
B-6.7.2 Except when necessary for hygienic
or processing purposes, no substance which
could contaminate drinking water should be
used or stored in drinking water handling
areas.
B-6.8 Personal Effects and Clothing
Personal effects and clothing should not be Protective clothing should not be permitted to
deposited in drinking water handling areas.
be taken out beyond change room. Separate
cabinets for storage of personal belongings
should preferably be provided.
B-7 Personnel; Hygiene and Health Requirements.
B-7.1 Hygiene Training
Managers of establishments should arrange
for adequate and continuing training of all
water handlers in hygienic handling of
water and in personal hygiene so that they
understand the precautions necessary to
prevent contamination of drinking water.
B-7.2 Medical Examination
Persons who come into contact with Medical examination of all workers, testing
drinking water in the course of their work personnel and supervisors should be got done at
should have a medical examination prior to least once in a year or as and when required. In
employment, if the official agency having case any new worker joins, his fitness with
jurisdiction acting on medical advice, respect to freedom from communicable diseases
considers that this is necessary, whether should be first medically examined before
because of epidemiological considerations permitting work in water processing area.
or the medical history of the prospective
water handler. Medical examination of
water handlers should be periodically
carried out and when clinically or
epidemiologically indicated.
B-7.3 Communicable Diseases
The management should take care to ensure Medical examination report should clearly
that no person, whether known or suspected indicate that the workers are free from any
to be suffering from, or to be a carrier of a communicable diseases.
30

disease likely to be transmitted or afflicted

with infected wounds, skin infections, sores
or diarrhea, is permitted to work in any
drinking water handling area in any capacity
in which there is any likelihood of such a
person directly or indirectly contaminating
drinking water with pathogenic microorganisms. Any person so affected should
immediately report to the management.
B-7.4 Injuries
Any person who has a cut or wound should
not continue to handle drinking water or
contact surfaces until the injury is
completely protected with a waterproof
covering which is firmly secured and which
is conspicuous in colour. Adequate first-aid
facilities should be provided for this
purpose.
B-7.5 Washing of Hands
Every person, while on duty in a drinking
water handling area, should wash the hands
frequently and thoroughly with a suitable
hand cleaning preparation under running
warm water. Hands should always be
washed
before
commencing
work,
immediately after using the toilet, after
handling contaminated material and
whenever necessary. After handling any
material which might be capable of
transmitting disease, hands should be
washed and disinfected immediately.
Notices requiring hand-washing should be
displayed.
There should be adequate
supervision to ensure compliance with this
requirement.
B-7.6 Personal Cleanliness
Every person engaged in a drinking water
handling area should maintain a high degree
of personal cleanliness while on duty and
should, at all times while so engaged, wear
suitable protective clothing including head
covering and footwear, all of which should
be cleanable, unless designed to be disposed
off and should be maintained in a clean
condition consistent with the nature of the
work in which the person is engaged.

Availability of first aid box should be ensured.

Foot operated or photo sensitive taps may

preferably be used.

Wearing of protective clothing should be

ensured when the plant is in operation.

31

Aprons and similar items should not be

washed on the floor. When drinking water
is manipulated by hand, any jewellery that
cannot be adequately disinfected should be
removed from the hands. Personnel should
not wear any insecure jewellery when
engaged in handling drinking water.
B-7.7 Personal Behaviour
Any behavior which could result in Proper notices in this regard should be
contamination of drinking water, such as displayed in local languages at appropriate
eating, use of tobacco, chewing (for places.
example, gum, sticks, betel nuts, etc.) or
unhygienic practices, such as, spitting,
should be prohibited in drinking water
handling areas.
B-7.8 Visitors
Precautions should be taken to prevent General visitors should be prohibited for
visitors as far as possible from visiting the entering into processing area.
drinking water handling areas.
If
unavoidable, the visitors should observe the
provisions of B-6.8 and B-7.3
B-7.9 Supervision
Responsible for ensuring compliance by all Hygiene supervisor should be other than the
personnel with the requirements of B-6.1 to one responsible for production. However, the
B-6.8 and the responsibility should be overall supervision for requirements of B-6.1 to
specifically
allocated
to
competent B-6.8 may be done by a senior person
supervisory personnel.
irrespective of actual work area.
B-8 ESTABLISHMENT: HYGIENIC PROCESSING REQUIREMENTS
B-8.1 Raw material Requirements
To guarantee a good and stable quality of See explanatory note given in Cl. B-5.4.1.1
drinking water, the quality criteria should be
monitored regularly.
B-8.2 Should there be a perceptible lacking
in meeting the requirements, necessary
corrective measures are immediately to be
taken.
B-8.3 Treatment
The treatment may include decantation, IO should specifically report the type of
filtration, combination filtration (for processes adopted by the firm for production
example, membrane filters, depth filters, and disinfection..
cartridge
filters,
activated
carbon), Any subsequent change in the process should
demineralization, reverse osmosis, aeration, be positively informed to BIS for action (see
and disinfection.
Section 5 of Manual)
B-8.3.1 Processing should be supervised by
technically competent personnel.
B-8.3.2 All steps in the production process, The water processed in a day should be filled/
32

including packaging, should be performed

without unnecessary delay and under
conditions which will prevent the possibility
of contamination, deterioration, or the
growth of pathogenic and spoilage microorganisms.
B-8.3.3 Rough treatment of containers
should be avoided to prevent the possibility
of contamination of the processed product.
B-8.3.4 Treatment are necessary controls
and should be such as to protect against
contamination or development of a public
health hazard and against deterioration
within the limits of good commercial
practice.
B-8.4 Packaging Material and Containers
B-8.4.1 All packaging materials should be
stored in a clean and hygienic manner. The
material should be appropriate for the
product to be packed and for the expected
conditions of storage and should not
transmit to the product objectionable
substances beyond the limits specified. The
packaging material should be sound and
should provide appropriate protection from
contamination. Only packaging material
required for immediate use should be kept
in the packing or filling area.
B-8.4.2 Product containers should not have
been used for any purpose that may lead to
contamination of the product. In case of
new containers if there is a possibility that
they have been contaminated, they should
be cleaned and disinfected.
When
chemicals are used for these purposes, the
container should be rinsed. Containers
should be well drained after rinsing. Used
and, when necessary; unused containers
should be inspected immediately before
filling.
B-8.5 Filling and Sealing of Containers
B-8.5.1 Packaging should be done under
conditions that preclude the introduction of
contaminants in the product.

packed on the same day. The left out processed

water should be either drained or reprocessed
(on the subsequent day).

Reusable containers where transparency or

shape is impaired because of repeated use,
should be rejected.

Separate stores should be available for

packaging material, finished products and other
items. Containers/ bottles received or blown by
the firm should preferably be stored in a closed
mouth polybag/ caps to avoid any
contamination.

The reusable containers and caps should be

cleaned, disinfected, washed and jet rinsed
(with processed water) before filling.
Various options are available for disinfection
like use of chlorinated water (using
hypochlorite), food grade detergents like
Ranocide etc. However, use of disinfectants
(one or a combination) should be left to the
discretion of the manufacturer. Due care should
be taken that no residue of disinfectant is left in
the pipeline/ container.

Filling room should be regularly disinfected.

For this purpose, various options may be
assessed such as use of UV light, filling under
sterile positive pressure etc. However, selection
of disinfectant should be left at the discretion of
33

B-8.5.2 The methods, equipment and

material used for sealing should guarantee a
tight and impervious sealing and should not
damage the containers nor deteriorate the
physical, chemical, microbiological and
organoleptic qualities of drinking water.

manufacturer.
Air conditioner may also be provided in the
filling room, if required in view of ventilation/
environmental conditions of the area.
To ensure tight and impervious sealing, the
shrinkable sleeve may be used on caps and the
container may be held upside down to check for
any leakage. The above method is suggestive.
However, any other suitable method may be
used.
The container should be visually inspected for
any suspended particle etc. against an
illuminated screen.

B-8.6 Packaging of Containers

The packaging of containers should protect The reusable containers may preferably be
the latter from contamination and damage wrapped in a plastic (polyethylene) film/ bag to
and allow appropriate handling and storing. avoid any damage/ transparency to the
container. Every time new polyethylene cover
should be used.
B-8.7 Lot Identification
Each container shall be permanently marked The date of manufacturing should be clearly
with code to identify the producing factory indicated on the container itself, in one straight
and the lot. A lot is quantity of drinking line instead of any other combination which
water produced under identical conditions, may not be consumer friendly.
all packages of which should bear a lot Writing of batch No. in place of manufacturing
number that identifies the production during date should not be practiced unless it is declared
a particular time, interval and usually from a that batch number and manufacturing date are
particular processing line or other the same.
processing unit.
B-8.8 Processing and Production Records
Permanent, legible and dated records of Batch wise records of production and dispatch
pertinent processing and production details for each type of container should be maintained
should be kept concerning each lot. These separately.
records should be retained for a period that
exceeds the shelf life of the product or
longer if required. Records should also be
kept of the initial distribution by lot.
B-8.9 Product Durability
Product durability shall be declared on the Product durability should not be less than one
container as per 7.1 (g). It shall be based on month. Each type of container should be
in-house shelf life study and proper checks subjected for durability assessment and based
and records be maintained for the on the study conducted by the manufacturer, the
conformity of the declared product shelf life should be declared. Records of the
durability.
same should be maintained and may be verified
by IO.
Decision about the type of study should be left
34

with the manufacturer.

Durability study should be reassessed by the
licensee at least once in a year for each type of
container.
B-8.10 Storage and Transport of the End-Product
The end-product should be stored and The finished product should not be stored under
transported under such conditions as will direct sun light.
preclude contamination with and/or Manufacturer should invariably exercise to
proliferation of micro-organisms and protect inspect the end product available in distribution
against deterioration of the product or chain to ensure its compliance to the
damage to the container. During storage, specification. This may be done either directly
periodic inspection of the end-product or through proper arrangements with their
should take place to ensure that only dealer/ distributor.
drinking water which is fit for human Manufacturer should provide proper training to
consumption is dispatched and that the end- the distributor/ marketer for its proper storage
product specifications are complied with.
and distribution. Manufacturer is liable for the
product quality till it reaches the consumer.
7.

USEFUL TIPS FOR INSPECTING PERSONNEL

7.1
To verify the actual factory layout. The layout should clearly indicate the different locations
preferably including the following:
a)

Bore well or entry point for the source of raw water, pipeline etc.

b)

Raw water storage facility

c)

Plant for the manufacture of the product (with various stages)

d)

Filling/packing areas, change room, toilet(s), loading/unloading points

e)

Entry/exit with indications of double door/door closures/Air curtains wherever provided

f)

Stores for packaging material and finished product

g)

Laboratory

h)

Actual boundary/perimeter of the establishment

i)

If the premises are also used for residential quarters/other purposes, then specific mention of the
same be made with identified locations.

7.2
As product is under mandatory certification, it is unlikely to be in production during PI. It
is therefore essential to get some production & filling/packing done during the visit and then make
comments on the firms capability for the same.

35

7.3
It should be clearly reported in the PIR as to whether the filling/packaging adopted are
manually operated or automatic. It may be noted that the plastic cups, tumbler, pouch are required to
be filled only through automatic machine.
7.4
Sample be got tested in factory for some requirements possible to be tested, with purpose of
verifying manufacturing capability (process controls), competence of the QC personnel and working
conditions of test equipment.
7.5
For sample drawn for independent testing, requirement of Description, Odour & Taste should
be tested and reported in PIR, as these are subjective tests.
7.6

Shelf-Life (Best Before) Period should be clearly indicated on the test request.

7.7
STI requires holding material till such time the test results for Each Control Unit are known.
However in case of microbiological parameters each batch of Packaged drinking water is required to
be held for 48 hours so as to ensure that it conforms to all the microbiological parameters applicable
for each control unit except for the tests of aerobic microbial count at 210 C and yeast and mould,
which shall be reviewed for conformity on availability of their test reports after 72 hours and 5 days
respectively.Therefore it is important to assess the firms installed production capacity as well as
capability to store the product. Accordingly both the production capacity and storage facility need
to be reported.
7.8 Hygienic conditions need to be assessed as per every clause of Annex B of ISS. Declarations
made by the firm with respect to medical examination, Pest Control, Hygiene Schedule, Supervisor
designated for Hygiene maintenance, Overall Supervision, Criteria devised for assessing product
durability etc. be verified and reported.All aspects related to reusable containers, availability of
arrangements for washing, cleaning (outer surface), disinfection and rinsing be also verified and
reported.
7.9

Sample size for Testing of Packaged Drinking Water for Independent Testing

7.9.1 For all requirements except radio-active residues

Approximate 18 litre quantity is adequate if the samples are supplied in 2 litre or smaller containers
but in case the samples are available in large size packages, minimum two packages are required as
microbiological lab needs separate sample for ensuring aseptic handling. For example:
Capacity
of
bottle/Jar in litres
1
2
5
10
20
24

Numbers
to
be
drawn
18
9
4
2
2
2
36

7.9.2 For Radio-active residues

Approximate 10 litre quantity: one carton of bottles (containing 12 bottles/ cups) or one jar (of 10
litres and above) is adequate.
7.10 Guidelines for Reused Containers
Licensees are required to ensure use of only such jars whose transparency continues to meet the
minimum requirements of 85% as per IS 15410 even after its repeated use. BO may draw sample of
reusable container for ascertaining continued suitability over a period of time by getting the same
tested for transparency requirement. Every market sample of processed water filled in reusable jar
shall be got tested for transparency requirement also as per IS 15410. Jars which get deshaped and
mutilated during the course of use shall not be permitted. Licensees may be advised in this regard
strictly. Further action may be taken as per OMPC.

37

ANNEX 1
(Clause Ref. 4.2)
CHECK LIST FOR SCRUTINY OF APPLICATION
PACKAGED DRINKING WATER (IS 14543) &
PACKAGED NATURAL MINERAL WATER (IS 13428)
A.
1
2
3
4
5
6
7
8
9
a)
b)
10
11
a)
b)
c)
d)
12
a)
b)
c)
13
14
15
16

17
18
19
20

CHECKPOINTS
Complies (Yes/No)
Application is submitted with the required Fees
Complete Office address & Manufacturing address are given
Manufacturing address in various documents is same
Composition of Top Management is indicated and tallying with other
documents submitted with application (such as at 1, 6 etc.)
Copy of Partnership Deeds, List of Director etc., as applicable
Copy of Registration of the firm (if applicable)
Documentary evidence submitted for status as Small Scale etc
Type, Material and Capacity is clearly indicated
Brand Name Declaration
CM/PF 307 is submitted
Copies of agreements with Brand owners are submitted (wherever
applicable)
Plant Machinery declaration is submitted on CM/PF 305
Test Equipment
Declaration submitted on CM/PF 306 (covering equipment, glassware,
chemicals and media)
Least Count, Range and quantity of equipment are as per ISS
Calibration reports of required equipment are submitted
Consent letter from approved OSL is submitted for testing of
requirements for which in-house facilities are not available
Personnel for Chemical & Microbiological Test
Whether copies of appointment letters submitted
Whether qualification of personnel are in order
Whether copies of qualification certificates submitted
Raw Water-Permissible source of raw water is used
Details regarding procurement/manufacturing facilities for packing
materials are submitted
Details of Manufacturing Process with Treatment for Disinfection and
Process Flow Chart are submitted
Factory Layout Plan indicating locations of important facilities (source
water, processing stages, disinfection, packing, storing, testing etc) is
submitted
Location and Route Map to factory is submitted
Production Figures for previous/current periods (as applicable)
Installed Capacity is clearly indicated
Acceptance of STI is submitted/ indicated
38

21
22
a)
b)
c)
23
24
25
B
1
2
C
1
2
a)
b)
3
4

Acceptance to pay Marking Fees is submitted/indicated

Hygienic Conditions whether copies of reports submitted for
compliance to Annex B
medical examination of concerned staff
Pest Control Treatment (if got done from outside source
Declaration submitted for Shelf-Life of product packed in all
containers
Details of previous application/licence provided, as applicable
Whether request made for blocking of Licence No. If so, whether Indemnity
Bond submitted

CHECKPOINTS SPECIFIC TO NORMAL PROCEDURE

Complies(Yes/No)
Whether date for preliminary inspection is proposed
Whether details of samples being offered for inspection (water and
packaging materials) are indicated
CHECKPOINTS SPECIFIC TO SIMPLIFIED PROCEDURE
Complies(Yes/No
Whether Self-Evaluation Report submitted
Original Test Report for Water & Containers
Whether the reports submitted are from approved Labs
Whether the reports are not older than 30 days
Whether undertaking for compliance to Labeling Prohibition
submitted
Whether undertaking submitted for stoppage of marking in case of
failure of verification sample in independent testing

Any other details/comments

Recommendations of Dealing Officer

Sign. Dealing Officer

Name
Date

Decision of Group Leader

39

CM/PF 201
Sept 1995
ANNEX 2

(Clause Ref. 4.3.1)

BUREAU OF INDIAN STANDARDS
REPORT OF PRELIMINARY INSPECTION
Application No. CM/A-

IR No.. . . . . . . . ..

IS

Date of writing IR . . . . . . .

Product
Type/ Size/Grade/Variety
1.

GENERAL INFORMATION

a) Applicants Name
b) Address:

i) Factory
ii) Office:

c) Date of inspection
d) Situation of factory
e) Telephone/Fax

i) Factory

2.

ii) Office
Management Staff

3.

Person(s) contacted

4.
BIS Licences, if any, held by the applicant
________________________________________________________________________
REMARKS OF THE REVIEWING OFFICER (ON IRS, TRS , GENERAL ETC)

_____________________________________________________________________________
40

(2)
CM/PF 201
Sept 1995
5.

RAWMATERIALS

a) Raw Materials Used:

Sl. No. Raw Material

Name of
Supplier

With or
Without
BIS Certification
Mark

Test
Certificate
of the
Supplier

How
Received
Batches/
Lots
Nature of
Package
____________________________________________________________________________

b) Arrangement for testing

as received
c) Details of sampling
d) Methods of disposal of
sub-standard raw materials
e) Record of tests with
proforma of records
6.

MANUFACTURE

a)

Type/ Size/Grade/Variety being

manufactured at the time
of inspection

b)

Description of the process from

raw material to finished product
stage ready for dispatch (Also
enclose Layout plan of the factory)

41

(3)
CM/PF 201
Sept 1995
c)

Intermediate points where control

is exercised

d)

Details of records maintained and

control used

e)

Method(s) of disposal of sub-standard products

f)

Units of production

g)

Production per day or per shift

h)

Details of manufacturing machinery

(See proforma PF 305 Annexed)

i)

Technical comments on the manufacturing

capabilities and inprocess controls

7.

PACKING AND MARKING

a) Nature of packing

b) Quantity per package

c) Marking on article

d) Method of marking (printing,

stenciling, embossing etc)

e) Form of label(s), if any

f) Batch or Code numbering for
identification
g) In what manner marking differs
from the provisions in the Indian Standard
Specification
42

(4)
CM/PF 201
Sept 1995
8.

LABORATORY AND INSPECTION

a)

Details of Staff:

Sl. No.

Name of
Qualification
Experience
Person
____________________________________________________________________________

b)

Competency of testing
personnel

c)

Equipment and other

facilities for complete
specification testing.
Test equipment/chemicals
not available

d)

Accuracy of instruments and

arrangements for calibration

e)

Records maintained in
laboratory for routine tests:

Sl. No.
Requirement/Characteristic
Value
____________________________________________________________________________

f)

Stage of processing where

laboratory reports are made
available

g)

Sampling and testing of end

products

43

(5)
CM/PF 201
Sept 1995
9.

SAMPLE
a) Source of drawl: stock/production
b) Size of lot from which sampled
c) Type/ Size/Grade/Variety of the sample
d) Details of the counter sample left with the firm
e) Manner of packing, labeling, coding and sealing
f) How sealed ? Give impression of the seal used
g) Laboratory to which dispatched
h) Test results on a sample tested in the factory:

Requirements
Tested

Value
Obtained

Value
Recorded
By Firm

Remarks

i) Any further information

regarding sample drawn
j) Information regarding sample of
other type/grade/variety applied for

k) Comment in the testing capabilities

44

(6)
CM/PF 201
Sept 1995
10. OTHER INFORMATIONS

a) Main buyers and selling price

b) Storage facilities
c) Hygienic conditions (in case of
food products, give complete note
as per relevant hygienic code)
d) Discussion with the firm on:
e) STI and marking fee rate
i) The manner of putting the
Standard Mark
ii) Manner of manufacture and
dispatches without Standard
Mark in case of stoppage of
marking
11.

INSPECTION/TESTING CHARGES

12.

CONCLUSIONS, RECOMMENDATIONS
AND POINTS FOR ACTION

Collected/Not Collected

Signature:
No. of Encl.:

Inspected by:
(Name)
Designation:

Station:

Date:
45

ANNEX 3
(Clause Ref. 4.3.2)
VERIFICATION REPORT BY BIS INSPECTING OFFICER
(The Inspecting Officer(s) shall give technical comments on manufacturing capability, in process
controls, competency of testing personnel and testing capability. Any discrepancy observed during
verification at factory shall be conveyed formally through D/V Report)
1. Application No.

2. Applicant

3. Address

4. Date of Visit

5. IS No.

6. Product

7. Person(s) Contacted:
8. VERIFICATIONS
S.No Aspect
.
a
Manufacturing
Facilities
b

e
d

Verification

Applicants declaration on PF 305 be verified

for completeness and correctness and
countersigned
Manufacturing
Applicants declaration regarding process,
process
filling and packing be verified for correctness
including filling and countersigned
and packing
Testing
Applicants declaration on PF 306 be verified
Facilities
for completeness and correctness and
countersigned
Requirements
Copy of consent letter from OSL including
for
which each requirement and frequency specified in
Testing facilities STI, be obtained and enclosed with this
are not available report
Factory Testing
Sample be got tested in factory and test report
be submitted in format Annex-3A
Competence of Competence be assessed for Microbiological
Q.C. personnel
and Chemical testing through factory testing,
interview etc.

Observation *
Complete
Incomplete

or

Conforming or Non
conforming

Complete
Incomplete

or

Available
and
complete or not
available/incomplete
Sample Pass or Fail
Q.C competent or
Not competent

46

Hygienic
Conditions

Assessment be made as per Annex B of the Satisfactory

or
Indian standard and reported using Annex 4 Needs improvement
of this manual duly countersigned by IO and
applicants Hygiene Incharge .

* In case the observations are not satisfactory for any of the aspects and for which actions are required to
be taken by the applicant, details be given in D/V Report.
9.

SAMPLES FOR INDEPENDENT TESTING

a) Details of samples drawn for independent testing be given in the Annex-3 B.

Whether left with the applicant for dispatch to Lab or brought to office?
10. ACCEPTANCES & DECLARATIONS BY THE APPLICANT
S.No. Subject
a
b
c
d

Whether already Whether

submitted
obtained now
Yes
No
Yes *
N.A.

Acceptance of STI
Acceptance of Marking Fee
Brand Name Declaration with Copies
of Agreement, if applicable
Undertaking for stoppage of marking
if verification sample fails in
independent testing

* Documents which are obtained during verification visit be Annexed with the report, duly marked.
11. ANY OTHER POINT/COMMENT (Give details of verification of other actions taken by
applicant on advise rendered by BIS based on scrutiny of application or otherwise asked for, if any)
12. RECOMMENDATIONS

13. POINTS FOR ACTIONS (Give details of all actions required to be taken by the applicant as
per deficiencies indicated on the D/V Report)
Signature
Name
Designation
Date
Group Leader

47

ANNEX 3A
FACTORY TESTING REPORT
P D water/ P NM Water
Manufacturing Date
Batch No. (if applicable)
Type of Container from which sample drawn
Quantity in stock pertaining to above Batch/Mfg. Date
IS
S.No. clause
Ref.

Requirement

Specified Value

Observed Value

Result : Pass for the requirements tested or Fail in the requirement(s)

(strike out whichever is not applicable)
Signature
Name
Designation
Representing

Chemist
(BIS)

Microbiologist

Firm:

48

ANNEX 3B
SAMPLES FOR INDEPENDENT TESTING
1.

Sampling of P D Water or PNM Water

a) Source of drawl (Stock/production)

b) Size of lot (quantity) from which sample is drawn with details of type/material/Capacity
c) Batch No. (if applicable) and Mfg. Date of Water
d) Declared shelf-life
e) Quantity drawn (indicate no. of packing & capacity)
f) Code assigned to the sample (Give separate codes for samples sent to different Labs., such as for
chemical & radiological)
g) Manner of packing, labeling and sealing
h) Tests to be carried out and name of the Lab. where sample is to be tested (Chemical, Physical,
Microbiological, Radiological)
2. Sampling of Packaging Material for Water
a) Type, Material and Capacity of container(s)
b) IS No. and Standard
c) Size(s) of lot(s) from which sample(s) drawn
d) Quantity drawn (indicate no. of packing & capacity)
e) Declared parameters (Width of PE Film, Wall Thickness of plastic container)
e) Code assigned to the sample
f) Manner of packing, labeling and sealing
g) Tests to be carried out and name of the Lab. where sample is to be tested
3.

Details of counter samples left with the firm:

49

ANNEX 4
(Clause 4.3.4 and 4.3.6)
CHECKLIST FOR GOOD HYGIENE PRACTICES AND FOOD SAFETY SYSTEMS FOR
PACKAGED NATURAL MINERAL WATER PROCESSING UNITS AS PER CLAUSE 5 OF
IS 13428:2005 OR CHECKLIST FOR GOOD HYGIENE PRACTICES AND FOOD SAFETY
SYSTEMS FOR PACKAGED DRINKING WATER PROCESSING UNITS AS PER
CLAUSE 4, ANNEX C OF IS 14543:2004 (TO BE VERIFIED BY IO DURING
PRELIMINARY/VERIFICATION VISIT)
Sl.
No.

Requirements

Building, Facilities and Locations

i)

Is the facility located in an area free from

objectionable odour, smoke, dust or other
contaminants and not subject to flooding?
Are the areas immediately surrounding the
buildings, roads, parking places, suitably
paved, grassed and kept clean?
Is adequate facility for drainage of
surroundings available and designed to handle
peak load?
1s the facility used for processing water free
from domestic animals?
Are the facility surroundings free from refuse,
waste materials, rubbish, over grown weeds
and grasses?
Are there adequate facilities for the disposal
of effluents and wastes?
Are the buildings and facilities of sound
construction and maintained in good repair?
Are the buildings and facilities designed and
maintained to prevent entrance and harboring
of pests and entry of contaminants?
Are building and facilities designed to
facilitate hygienic operations?
Plant and Physical Facilities
Is adequate lighting provided at working
station, hand washing area, and storage areas?

ii)

iii)

iv)
v)

vi)
vii)
viii)

ix)
B.
i)
ii)

Answers
Satisf- Unsatis
actory factory

Remarks
(briefly
describe how required
is met or not )

Is the lighting intensity adequate:1) 540 lux in

all inspection area, and 2) 220 lux in work
areas and walls
50

iii)

iv)

v)

vi)
vii)

viii)

ix)

x)

C
i)

ii)

iii)

iv)
v)

Are light fixtures safety types and protected to

prevent contamination in the event of
breakage in the processing and packing area?
1s adequate ventilation provided in processing
areas to minimize odours, noxious fumes and
condensates?
Are barrier traps provided at drains to prevent
the entry of rodents from the drains into the
facility?
Is effective screening provided against entry
of birds, animals, insects, rodents, etc
Are doors, hatches and other openings to the
building constructed in such a way to render
opening pest proof?
NOTE Installation of one or more of the
following, which effectively prevents pest
entry, will meet this requirement:
a) Doors self closing type,
b) Have air curtains, and
c) Have strip curtains.
Are floors, walls, ceilings, windows and doors
so designed and constructed as to prevent
accumulation of dust, dirt and render them
washable?
Is product in process and storage area
adequately protected from any leakage from
external surfaces and other sources of
contamination?
Are immediate surroundings of extraction or
collection
protected
from
entry
of
unauthorized persons?
Raw Water Processing
In case of extraction /collection for processing
are the sources free from contaminations/
impurities?
Are water storage tanks, pipe lines utilized for
handling water constructed and so designed as
to facilitate cleaning and inspection?
Are inspections of containers/ carriers/
pipelines of raw water supply performed for
the material of construction and cleanliness?
Are possible chances of contamination from
incoming water assessed?
Are water storage tanks effectively cleaned to
prevent entry of pests and potential
51

vi)
vii)
viii)

D
i)

ii)
iii)
iii)

iv)
v)
vi)
vii)
E
i)

ii)
iii)

iv)
F
i)
ii)

contaminator?
Are the storage tanks periodically cleaned and
records maintained?
Are the processed water contact surfaces
regularly cleaned and sanitized?
Are all equipment and utensils so designed
and constructed as to prevent hygiene hazards
and allow easy cleaning and sanitation?
Post-Processing Handling
Are cleaning operations of bottles/containers
so done as to preclude contamination of
product and product contact services with
residues?
Has absence of residual cleaning chemicals
been ensured?
Is preventive maintenance in place for all
processing machinery and equipment?
Are the primary packing material and
containers of food grade conforming to
relevant Indian Standards?
Are packing and sealing, where required,
monitored?
Are
containers
visually/electronically
inspected for their soundness?
Are physical hazards prevented from entering
into processed water?
Are glassware excluded from production
area?
Packaging Material and Finished Goods
Storage
Are the primary packing material and
containers of food grade conforming to
relevant Indian Standards?
Are packaging material inspected to ensure
their suitability?
Are the packing materials especially primary
packing material properly stored and properly
handled to preclude contamination?
Are packaging material purchased, stored and
handled in sanitary manner?
Finished Product Storage and Distribution
Is first-in-first out (FIFO) of stored product
maintained?
1s storage properly sanitized and disinfected
periodically?
52

iii)

Are stores protected from pest infestations?

iv)
v)
vi)

Are coding and tracking clear and in place?

Are the instructions clear and in place?
Are hold release procedure in place and
product identified?
Are the records maintained for batch number,
date and volume of production?
Are transport containers/vehicles maintained
in clean condition?
Customer Handling of Products
Are the storage instructions provided on
containers?
Is the shelf life period (best before) mentioned
on containers in accordance with PFA
requirements?
Are instructions provided for handling
defective/ damaged products?
Sanitary Facilities and Control
Are toilet provided in sufficient numbers and
are they provided with:
1) Doors of self closing type?
2) Opening directly into processing areas?
3) Hand washing signs provided in
appropriate language?
4) Proper lighting and ventilation?
5)Proper maintenance to keep in clean and
tidy manner?
Are hand washing facilities provided
adequately and conveniently to wash hands,
foot, elbow with sensor operated taps?
Are germicidal soaps / soap solution and hand
drying facility provided?
Are notice/instructions prominently pasted in
toilet directing employees to wash their hands
on entry and re-entry into the food handling
areas?
Are the refuse receptacles, self closing type,
maintained in a manner to protect from
Personnel Hygiene and Habits
Is any individual assigned to supervise overall
sanitation of plant and personnel?
Is there any person responsible for day-to-day
monitoring of health and hygiene?

vii)
viii)
G
i)
ii)

iii)
H
i)

ii)

iii)
iv)

v)
J
i)
ii)

53

iii)
iv)

v)

vi)

Have the employees in processing, packing

and maintenance been medically examined?
Are the personnel with infectious diseases,
skin infection and open lesion or any other
source of microbial contamination excluded
from working in process/packing areas?
Are personnel hygiene practices regularly
maintained and monitored?
1) Clean outer garments protective
clothing?
2) Personal cleanliness finger nails?
3) Head cover hair restraints, caps, head
bands, beard cover
4) No tobacco in any form smoking,
chewing
5) No eating at work stations
Are protective clothing stored on the premises
and not allowed to be used for outside wear

vii)

Are there clear legible notices defining limits

of no smoking areas such as NO SMOKING
BEYOND THIS POINT displayed?

viii)

Are personnel imparted regular training or

hygienic food handling, processing food and
personal hygiene?
Are unsecured jewellery and other objects,
such as, wrist watches, cufflinks, ear rings,
glass bangles, stick BINDIS removed at
work?

ix)

CONCLUSION: OVERALL ASSESSMENT

SATISFACTORY / NOT SATISFACTORY

NAME OF UNIT
CM/A..............

OF

HYGIENIC

CONDITIONS

Signature ..
Name
..
Designation ..
Date.

54

ANNEX 5
(Clauses 1.1, 4.3.3)
A TYPICAL MANUFACTURING PROCESS
Following treatment steps are involved in the manufacturing process for packaged drinking water:
Raw Water Raw Water Storage Tank Raw Water Feed Pump dosing system 1 & 2 Pressure
Sand Filter Activated Carbon Filter Micron Cartridge Filter High Pressure Pump Reverse
Osmosis Ozone generator and re circulation Finished Water Storage U.V System Filling
and Packing Visual Examination Storage for testing Forwarding.
1) DOSING SYSTEM 1 & 2 - The water is drawn from Bore Well or any source and collected in
storage tank. It then goes to dosing system through raw water feed pump with use of antiscalant
for softening the water.
2) PRESSURE SAND FILTER - From softener, the water is transferred to pressure sand filter for
removing the impurities.
3) ACTIVATED CARBON FILTER - The water is then passed through activated carbon filter to
remove organic impurities.
4) MICRON CARTRIDGE FILTER (MCF) - Water is then passed through a micron filter or a
series of such filters (0.1 0.5 u) for removal of fine particles.
5) DEMINERALISATION BY REVERSE OSMOSIS SYSTEM (R.O.) - Water from MCF goes
to R.O. System through High Pressure Pump. R.O. removes 90-95% of dissolved solids. The
finished water is passed into Storage Tank through SS/ inert pipe line.
6) OZONE GENERATOR WITH RE-CIRCUALTION - Finished water from R.O. system is
stored in S.S storage tank. The tank is provided with a Man Hole so that the tank can be cleaned.
This tank is used as ozone circulation tank. The ozone is passed to this tank for disinfection.
7) U.V. SYSTEM - Water from S.S. tank is passed through MCF to U.V. disinfection system,
where the bacteria are inactivated.
8) FILLING AND PACKING - Water is then filled in cleaned and rinsed containers.
9) VISUAL EXAMINATION - Containers are visually inspected for any leakage and suspended
matter against illuminated screen.
10) TESTING - The raw water is tested once in three months. Finished water is tested as per
scheme of testing prescribed by BIS.

55

A TYPICAL PROCESS FLOW CHART

RAW WATER EXTRACTION THROUGH BORE WELL

RAW WATER STORAGE

TESTING
CHLORINE DOSING

FILTRATION THROUGH SAND BED

FILTRATION THROUGH ACTIVATED CARBON BED

MICRON CARTRIDGES FILTRATION

FEEDING BY HIGH PRESSURE PUMP

ANTISCALANT DOSING
REVERSE OSMOSIS

RO OUTPUT
OZONE INJECTION WITH

RE-CIRCULATION
U.V. SYSTEM

FINAL PRODUCT STORAGE

FILLING AND PACKING

PRODUCT TESTING

DESPATCH

56

A TYPICAL CIP PROCESS

Sanitization and Sterilization is done daily before resuming production
SANITIZATION
1.
2.
3.
4.
5.
6.
7.
8.

Take sufficient quantity of soft water in CIP tank.

Add required quantity Sodium Hypochlorite solution in CIP tank containing soft water.
Now start CIP pump.
Let the chlorine solution go into tank through CIP line.
Solution will go from top through CIP volume which distributes solution in entire tank.
Check the available chlorine.
Chlorine (free) should be 10-15 PPM.
If percentage of chlorine is less then add more Sodium Hypochlorite solution till required strength
of chlorine is achieved in water.
9. Start feed pump and pass solution through sand filter, (bypassing carbon filter since it removes
chlorine), all micron filters, Ozone contact column etc. and filling machine.
10. Hold this solution at least for 30 minutes which can be extended to overnight.
11. Drain out the solution from the whole system.
12. Take fresh water and remove the chlorine of storage tank.
13. After removing chlorine traces from storage tank, fill with fresh bore well water.
14. Remove the chlorine traces from each points upto filling machine by flushing with fresh water.
15. Check for residual chlorine.
16. Do final washing with product water.
STERLIZATION
1.
2.
3.
4.
5.

Produce soft water by softener

Generate steam by boiler using soft water.
Supply steam in storage tanks, bore well line and pipe lines upto filling machine.
Continue the steam supply in tanks till attains required temperature.
Continue the steam supply to filling machine till steam comes out from all rinsing and filling
nozzle of machines.
6. Stop steam supply and disconnect the hose pipe.
7. Rinse the whole system with product water.

57

TYPICAL CLEANING AND WASHING SYSTEM OF RE-USABLE JARS

The process of cleaning and washing of re-usable jars is as follows:1. Check the jars for crack, contamination and foul odors. Reject jars not fit for re-use.
2. Wash the outside of jars thoroughly with detergent solution and normal water.
3. After outer cleaning, wash jars internally with food grade detergents (like iodine based) and then
thoroughly wash till free of last traces of detergent.
4. Send clean jars to filling station.
5. Rinse jars internally with product water, before final filling at filling station.

58

ANNEX 6
(Clause 4.10)
CHECK LIST FOR RED FORM OF PACKAGED DRINKING WATER (IS 14543) and
NATURAL MINERAL WATER (IS 13428)
ITEM
Address

Authorized Person

Status of Unit

STI
Marking fee

Brand Name(s)

Test Reports

CHECK POINT

DOCUMENT
No. (Tick)
Same
address
given
in 1
Application Form, PIR, RF and 1 (a) etc.
Other Documents
Authority Letter (In case 2
application and other
documents are signed by person
other than Proprietor/Partner/
Director of the applicant)
Manufacturing status is clearly 3
stated as large/small scale in
order to give concession in
marking fee.
Acceptance of STI is for the 4
latest version
Acceptance
of
applicable 5
Marking Fee with complete
details
Proforma
CM/PF
307 6
Agreement with Brand Owner, 6 (a)
if applicable
6 (b) etc.
Reports for Water cover all the 7
requirements for
7 (a)
7(b)
Physical/ Chemical Tests
7 (c) etc.
Microbiological Test
Pesticides Residues
Radio Active Residues

Approval
of
Competent
Authority for change of lab, if
applicable
Factory Testing in Permission
of
Competent
lieu of I/T
Authority
Manufacturing
Plant machinery declaration
Facilities
including details for source and
storage of raw water
Testing
Testing facilities including

Verify in application. Plot Purchase/ Rent

agreement or lease agreement etc.

SSI
Certificate/Chartered
Accountant/
Certificate from any other agency.

Should not be signed on blank proforma

Should not be signed on blank proforma

Enclose copies as applicable, for each brand

Reports of all samples to be attached, i.e.,

including those of failures, if any.
Pass/Fail to be clearly mentioned on each test
report by Dealing officer for samples drawn
by BIS for test reports verified by him/her
Code numbers and details of samples in TR
and IR tally.

Packaging material report for

the relevant type, material and
capacity
Approval of
Testing

REMARKS

Test reports under Simplified should not be

older than 30 days
8(a)

8 (b)
9

10

Factory test report should be as per CL

proforma,
CM/PF 305 should be countersigned by IO on
all pages.
CM/PF 306 should be countersigned by IO on

59

Facilities

details of test method adopted

by the firm, wherever options
available

Consent Letter
for testing in
Outside Lab

Firms request for permitting

testing at OSL, Consent from
OSL for testing on behalf of
applicant,
Permission by the CA
As a minimum, following
instruments shall be got
calibrated:
Analytical Balance
All Incubators
Appointment letters of testing
personnel
Qualification certificates of
testing personnel

11 (a)
11 (b)
11 ( c)

13 (a)

Testing personnel should be employed as fulltime.

Verification of competence should be clearly
recorded by IO.

Preliminary Inspection Report

14(a)

Raw Material receipt details

14(b)

Manufacturing
Process

indicating complete process,

treatment for disinfection (for
each type of packing, if
different)
Process Flow Diagram

14( c)

Report to clearly indicate availability of

infrastructure for manufacturing & testing of
product as declared by the applicant.
Declarations made by the applicant on the
prescribed proforma should be verified and
countersigned by the IO.

Calibration of
Instruments

Quality
Control
Personnel

Preliminary
Inspection
Report
(for Old Procedure)

all pages.

Permission should to be granted only for

requirements having frequencies of test as
monthly & above

Copies of calibration certificates to clearly

indicate the validity status and traceability
12 (a)
12 (b) etc.

14(d)
14(e)

Layout Plan of Factory

clearly indicating locations of
raw water source & storage,
process
equipment,
plant 14(f)
machinery, Packing & Storage
Area, Change Room, Toilet etc. 14(g)

Discrepancies, if observed during the

Preliminary Inspection, should have been
conveyed through D/V report and also
attached with the preliminary inspection
report

Report of testing of raw water

14(h)
Firms own testing of processed
water indicating conformity to
ISS
Reports of plastic containers
submitted by firm, as applicable
Any other document such as :
Test Results of samples tested
in factory (if not reported in
PIR)
Sample Labels, if available

14 (i)
14 (j)

60

Contact Report

Visits other than Preliminary 15(a)

Inspection
15 (b) etc.

Verification Visit
under
Simplified
Procedure
Hygienic
Conditions

Report of verification
Factory testing Report

16 (a)
16 (b)

Complete assessment as per

Annex B
Medical
Examination
of
employees
Pest Control treatment (as
applicable)

17(a)
17(b)
17( c)

Declarations by the Undertaking to intimate BIS

firm
regarding shifting of Plant
Machinery/Test Equipment

Annex III or Annex IV to be used by IO. All

the declarations made by the applicants shall
be verified and countersigned.
Assessment report should be countersigned by
IO.

18

19
Ownership
of
Plant
Machinery/Test Equipment
(if not covered under Doc. No.
9 & 10)
Affidavit on Stamp paper for
material offered for inspection
(for sample drawn from stock)

20

21
22

Indemnity Bond (for Blocking

of CM/L-No.)

Any Other
Documents
Red Form

Undertaking
regarding
cancellation of licence in case
verification sample fails
Other documents, as relevant to 23 onwards
the
Application
Should be complete in all
respect

Clear recommendations for scope w.r.t Type,

Material & Capacity of containers

Recommendations of Dealing Officer & Date

GL
Head

61

CM/PF /PDW
AUG 2009
ANNEX 7
(Clause 5.2)
BUREAU OF INDIAN STANDARDS
REPORT OF PERIODIC INSPECTION
(. .. . . . . . . . . . . . inspection since the grant of licence/Renewal)
CM/L Valid upto:

IR No.. . . .
Date of writing IR . . . . . . .

1. a) Licensee
b)IS 14543:2004 Packaged Drinking Water (Other Than Packaged Natural Mineral Water)/
IS 13428:2005 Packaged Natural Mineral Water
Type, Material & Capacity of containers covered under licence
c) Other license(s) held
4

CM/L . . . . .. . . . . IS

Product

Special inspection charges, if applicable, with details of realization

3. Date(s) of inspection
4. Person(s) contacted
5. Change in Management, if any
6. Previous inspection
a) Date(s)
c) Conclusion and Recommendations

b) Conducted by

d) Details of last 2 factory samples

Sl. No. Date of drawl Mode & Date Status of sample
Pass/Fail
of sample
of dispatch
(whether report recd.) (if applicable)
---------------------------------------------------------------------------------------------------------------1.
2.
--------------------------------------------------------------------------------------------------------------7. ACTION ON ADVICE RENDERED IN PREVIOUS INSPECTION OR OTHERWISE ASKED FOR
WHILE GRANTING LICENCE /RENEWAL OF THE LICENCE
_______
REMARKS OF THE REVIEWING OFFICER ON PERFORMANCE OF LICENSEE KEEPING IN VIEW THE
PAST PERFORMANCE (ON IRS, TRS , GENERAL ETC)
SIGNATURE & DATE

62

(2)
CM/L -
8. Source of Raw Water
a)
b)
c)
d)

Own Bore well/Municipality/Other Source Supply (specify)

Whether source changed from declared earlier
If yes, compliance to STI
Whether records of testing maintained as per STI
9. Packaging Material (Jar/Bottle/Cup/Glass/ Caps/Closures/Pouch-Give details in each case)
a) Details of Receipt
Container
Name of the Supplier

Type Material

Whether BIS Whether recd.with Whether tested

Certified
test certificate
in-house

Capacity

b)

Whether packing is done in approved container(s)? If not, give details

c)

Whether records being maintained in accordance with STI

10. PRODUCTION DETAILS

a) Whether Water being produced/packed at the time of inspection
b)

Whether any change in the process of manufacturing & disinfection from that declared
earlier? If yes, give details (Disinfection of natural mineral water is not permitted)

c)

Production Controls (Satisfactory/Unsatisfactory)

e) Production & supply since last periodic inspection (enclose details for completed
month)
i) Quantity produced
ii) Quantity marked
iii) Quantity unmarked and manner of disposal
iv) Reason for not marking
v) Parties supplied to (Give complete address):

63

(3)
CM/L -
11. Storing, Packing and marking of BIS certified material
a) Material held in stock
b) Packing and marking on packages
c) At what stage marking is done
(After or before test results are known)
d) Any change in the marking procedure from approved one
e) Compliance to Labeling Prohibitions
12.

TESTING ARRANGEMENTS & TESTING

a)

Details of change(s) in Testing Personnel, if any

since previous inspection

b)

Competence of new Testing Personnel

c)

Are the frequencies of tests and records

testing being maintained satisfactorily
vis--vis the STI

d)

Variation in factory test result

Enclose Report in Annexure 7A

e)

Details of testing got done from

outside laboratory

Enclose Report in Annexure - 7B

f)

Details of failure reported, if any and

corrective actions taken for the same

g)

Are all required instruments available and

in working order? If No, give details

h)

Change/addition in testing facilities/arrangement

i)

Details of calibration of Balance, Thermometers& pressure gauge

13 Testing in factory
Description of the sample (Type, Material, Capacity of containers and B.No./Mfg.Date):
Sl.No.Requirements Tested Value Obtained
Value Recorded
Remark

64

(4)
CM/L.

14. Samples for Independent Tests

a) From where sampled (Stock/production line)?
b) Details of sample (Batch/Lot No., Date of Mfg.
Shelf-Life and Type, Material and Capacity
c) Test record of the batch from which sample is drawn

Report in Annexure - 7A

d) Give details of packing, labeling, coding, sealing of the sample

e) Mode of dispatch and laboratory to which sample will be tested
f) Details of the counter sample left with the firm
15.
HYGIENIC CONDITIONS
a) Availability of responsible/designated hygiene control incharge
b) Overall compliance to Annex B of IS 13428/IS 14543
as verified as per the check-list attached
16.

Satisfactory/Unsatisfactory

CONCLUSION AND RECOMMENDATIONS

a) Assessment of performance since last inspection

Satisfactory /Unsatisfactory

b) If operated unsatisfactorily, give reasons

(Also indicate whether the discrepancies were
conveyed to the licensee through D/V Report, if so enclose copy)
c) Any discussion with the firm for difficulties,
in production, testing, operation of Scheme and
actions proposed, if any for the difficulties observed
d) Recommendation for action to be taken
f) Any other observation/comments for better
appraisal of the report

No. of Encl.:

Station:

Signature:
Inspected by:
(Name)
Designation:
Date:

65

CM/L .
ANEXURE 7A
ASSESSMENT OF COMPLIANCE TO IS 13428 FOR PNMW/IS 14543 FOR PDW
Sl. REQUIREMENT
No.
FOUR HOURLY
1.
Description
2.
Colour
3.
Odour
4.
Taste
5.
Turbidity
6.
pH
EACH CONTROL UNIT
1.
Total Dissolved Solids

LIMIT
PDW

PNMW

To comply
2 Max
Agreeable
Agreeable
2
NTU,
Max
6.5 to 8.5

2 Max
Agreeable
Agreeable
2
NTU,
Max
6.5 to 8.5

500 mg/l,
Max
2.
Chlorides
200 mg/l,
Max
3.
Sulphate
200 mg/l,
Max
4.
Alkalinity
200 mg/l,
Max
5.
Residual Free Chlorine 0.2
6.
Escherichia coli
Absent
7.
Coliform bacteria
Absent
8.
Sulphite
reducing Absent
anaerobes
9.
Pseudomonas
Absent
aeruginosa
10. Aerobic
Microbial a) 20/ ml,
Count
Max
at
0
37 C &
b) 100/ml,
Max at 20220C
11. Yeast & Mould Count
Absent
ONCE IN A WEEK
1.
Barium
1
mg/l,
Max
2.
Copper
0.05 mg/l,
Max
3.
Iron
0.1 mg/l,
Max

VARIATIONS BATCH DRAWN

FROM
FOR IT
RECORDS

150700
mg/l, Max
200 mg/l,
Max
200 mg/l,
Max
75400
mg/l
-Absent
Absent
Absent
Absent
--

Absent
1
mg/l,
Max
1
mg/l,
Max
0.1 mg/l,
Max
66

4.

Manganese

5.

Nitrate

6.

Nitrite

7.

Zinc

8.

Aluminium

9.

Calcium

10.

Magnesium

11.

Anionic
Agents
Sulphide

12

Surf.

0.1 mg/l,
Max
45
mg/l,
Max
0.02 mg/l,
max
5
mg/l,
Max
0.03 mg/l,
Max
75
mg/l,
Max
30
mg/l,
Max
Act. 0.2 mg/l,
Max
0.05mg/l
Max

2.0 mg/l,
Max
50
mg/l,
Max
0.02 mg/l,
Max
5
mg/l,
Max
0.03 mg/l,
Max
100 mg/l,
Max
50
mg/l,
Max
Not
detectable
0.05mg/l
Max

67

CM/L..
ANNEX - 7B
DETAILS OF TESTING GOT DONE FROM OUTSIDE LABORATORY
(PROGRESS SINCE LAST PERIODIC INSPECTION)
Sl.No

YEAR
MONTH

JAN

FEB

3
4
5
6
7
8
9
10
11
12

MAR
APR
MAY
JUN
JUL
AUG
SEP
OCT
NOV
DEC

MONTHLY,
B.NO./TR NO.
(RESULT/SENT)

3
MONTHLY,
B.NO./TR NO.
(RESULT/SENT)

6 MONTHLY,
B.NO./TR NO.
(RESULT/ SENT)

YEARLY,
B.NO./TR NO.
(RESULT/SENT)

TWO YEARLY TEST:

68

ANNEX 8
(Clause 5.2)
HYGIENE CHECK LIST
( VERIFICATION DURING PERIODIC INSPECTION/ SURVEILLANCE VISIT OF
PACKAGED DRINKING WATER / PACKAGED NATURAL MINERAL WATER AT BIS
LICENCED UNIT)
CM/LDATE OF VISIT:
NAME OF THE UNIT:
Particulars

Requirements

Observ
ation
Extraction/Collection The source of extraction is well Yes/No
protected from Contamination and
unauthorized access
Raw Water Storage
Storage tank for raw water is clean Yes/No
and cleaning schedule is being
followed.
Processing Area
- Processing area is clean and Yes/No
adequately closed.
- Adequate ventilation and lighting Yes/No
facilities available and working
- Wire mesh/glass provided on Yes/No
windows
- Walls and ceiling are well painted Yes/No
and clean.
- Flooring is smooth, sloped, clean Yes/No
and free from cervices.
- Freedom from insects, rodent and Yes/No
birds, animals etc.
- Fly-catchers provided.
Yes/No
- Not being used for storage
Yes/No
purposes.
- Drains are clean and well covered. Yes/No
- Doors are self closing/close fitting Yes/No
type with air-curtains
Hygienic Facilities
- No over flow/ dripping from Yes/No
processing vessels.
- Cleaning schedule of equipment is Yes/No
adequate and is being followed.
- Proper disinfection of containers Yes/No
and caps is being ensured.
- Washing and disinfection of
reusable jars is being done Yes/No
adequately
and
absence
of

Remarks, if any

69

Raw Material

Finished Product

Storage of finished
product

residual
cleaning
chemicals
ensured.
- Changing facilities are clean and
not being used as store.
- Toilets are clean and away from
processing area.
- Protective clothing being used by
workers coming in contact with the
product.
- Medical examination of workers is
being done periodically and
affected personnel are not allowed to
work.
- Adequate hand washing facilities
are available and notices to this
effect are displayed.
- Personnel are being trained in
food handling, processing and
personal hygienic.
- The raw material including bottles,
caps, etc. are properly stored and
free from probable contamination.
- TC of R/M is available
consignment wise.
- Finished product pipeline and
storage tank is of inert material and
is clean and free from corrosion.
- Cleaning schedule being followed
and supervised by identified
personnel.
- Inspection screen is provided and
is well lit.
- The packed material is stored
adequately
under
hygienic
conditions, free from chances of
contamination.

Yes/No
Yes/No
Yes/No

Yes/No

Yes/No

Yes/No
Yes/No

Yes/No
Yes/No

Yes/No

Yes/No
Yes/No

OVERALL ASSESSMENT OF HYGIENIC CONDITIONS:

SATIS./NOT SATIS.

Signature of I.O._______________
Name:________________________
Date:___________________

70

ANNEX 9
LIST OF TEST FACILITIES
A- ORGANOLEPTIC AND PHYSICAL REQUIREMENTS

Sl.
No.

(1)
1.

Tests

(2)
Colour

Clause Ref. of
IS 14543:2004
or
IS 13428:2005
(3)
5.2, Sl No. i)
of Table 1

Referred
Method of Test
&
Limit of
Detection
(4)
IS 3025 (P 4):1983
with Am. 1

Test Equipment/Apparatus

(6)

(5)
Nessler cylinders,50 ml
Centrifuge or filter assembly, functional pore
size 0.45m

i) Platinum cobalt
(Visual comparison
method)

ii) Spectrophotometric method

Chemicals/Reagents

Spectrophotometer,400-700 nm with 10 mm
absorption cell
Filteration system consisting of filteration flask
with side tubes
crucible holder
Micrometallic filter crucible, pore 40 m
Calcined filter aid (Celite 505 or equivalent
Vacuum system
Refrigerator (recommended)
pH meter
Centrifuge

Potassium chloroplatinate
Cobaltous chloride, crystalline
Conc. Hydrochloric acid
Distilled water

Conc. Sulphuric acid

Sodium hydroxide

71

2.

Odour

5.2, Sl No. ii) of

Table 1

IS 3025 (P 5):1983

Wide mouth glass stoppered bottles (approx. 1 lit.

capacity)

Odour free distilled water (or distilled water

and column of granulated activated carbon)
Hydrochloric acid

3.

Taste

5.2, Sl No. iii)

of Table 1

IS 3025 (P 8):1984

4.

Turbidity

5.2, Sl No. iv)

of Table 1

IS 3025 (P 10):
1984

5.

Total
dissolved
solids

5.2,Sl No. v) of
Table 1

IS 3025 (P 16):
1983 with Am. 1

Breaker (50 ml)

Water bath
Thermometer
Sample tubes
Turbidimeter
Volumetric flasks (100 ml)
Membrane filter with pore size not more than
0.45 m
Filter:
Filtering Assembly (suitable for type of filter
selected)
Drying oven (180 2C)
Desiccator
Analytical balance (200 g capacity, l.c. 0.1
mg)
Pipettes
Evaporating dish
Magnetic stirrer, recommended

Taste and Odour free water 2000 mg/l

solution of sodium chloride
Distilled water
Hexamethylene Tetramine
Hydrazine sulphate

72

pH

5.2,Sl No. vi) of

Table 1

IS 3025 (P 11):
1983

i) Electrometric
method

pH meter with glass and reference electrode

(saturated calomel) l.c 0.1
Magnetic stirrer with polytetrafluoro ethylene
coated stirring bar
Thermometer (l.c. 0.5C)
Beakers

Distilled water
Borax (for Borax buffer)
Potassium dihydrogen phosphate,
Sodium hydrogen phosphate and oven
(for phosphate buffer)

Potassium hydrogen tartarate (for Tartarate

buffer)

Potassium hydrogen phthalate (for Phthalate

buffer)

Potassium tetraoxalate dihydrate (for

Calcium hydroxide buffer)

Calcium Carbonate
Platinum dish, Muffle furnace, Hot Plate, Fritted
glass filter of medium porosity, polyethylene
bottle, Suction pump & fritted glass funnel (for
Tetra oxalate buffer)

ii) Colorimetric
Method

Hard glass tubes

Standard pH Buffer solutions/tablets

(Minimum two different values)
OR

Methyl orange, methyl red, bromothymol

blue, phenolphthalein and alcohol (66%) (for
universal indicator)
Thymol blue indicator (acid range)
Bromophenol blue indicator
Bromocresol green indicator
Methyl red indicator
Bromocresol purple indicator
Bromothymol blue indicator
Phenol Red indicator
Cresol Red indicator
Thymol Blue (alkali range) indicator
Thymolphthalein indicator
Thymol violet indicator
Different buffer solutions of known pH

73

B - CHEMICAL REQUIREMENTS

Sl.
No.

(1)
1.

Tests

(2)
Barium

Clause Ref.
of
IS
14543:2004
or
IS
13428:2005
(3)
5.2, Sl. No i)
of Table 2

Referred Method of
Test
&
Limit of Detection

Test Equipment/Apparatus*

(4)
i) Annex F of
13428:2005

Chemicals/Reagents

(5)
IS

(6)

Filter paper and filtration assembly

Hot plate/gas burner

Ammonium Dichromate
Ammonium Acetate
Ammonium Hydroxide
Potassium Iodide
Sodium Thiosulphate(0.1N)
Hydrochloric Acid
Ammonium Chloride
Starch indicator

Atomic Absorption Spectrophotometer and

Associated equipment (Burner, Readout
mechanism, lamp for Barium, Pressure
Reducing valves and vents)
Nitrous oxide burner head
T-junction valve or other switching valve
Air
Acetylene Gas
Nitrous oxide gas

Metal free water

Hydrochloric Acid
Nitric Acid
Sulphuric Acid
Hydroflouric Acid
Potassium Chloride
Standard barium solution 100g/ml
(Barium chloride, oven, hydrochloric
acid)

ii) IS 15302:2003

74

iii) IS 3025 (P 2)
:2004

2.

Copper

5.2, Sl No. ii)

of Table 2

Induction Coupled Plasma-Atomic Emission

Spectrometer
Sample Bottles
Glasswares
Acid Dispensers
Membrane Filtration Equipment and Filters
(0.45)
Hot Plate
Argon Gas

Nitric Acid
Hydrogen Peroxide
Sulphuric Acid
Hydrochloric acid
Ammonium Sulfate
Stock Solution of Barium

i) IS 3025 (P 42): 1992

with Am 1
a) Neocuproine Method
Spectrophotometer & 1cm cell
Hot plate
Separating funnels (125 ml)
Conical flasks

Detection range 0.05 to

5.0mg/l

Ammonium Hydroxide
Chloroform, AR Grade
Hydrochloric acid, Conc.
Hydroxylamine Hydrochloride
Isopropyl Alcohol
Neocuproine
Double Distilled water
Nitric Acid, Conc.
Sulphuric Acid, Conc.
Hydrated Sodium Citrate

Stock copper (II) solution 200g/ml

(Pure Copper Metal, hot plate)
Hydrogen Peroxide

b) Atomic Abso- rption

Method (Direct)

Atomic Absorption Spectro- photometer

with
air-acetylene flame & Copper Hollow
Cathode lamp

Hydrochloric Acid, Conc.

Nitric Acid, Conc.
Dilute Sulphuric Acid
Stock copper (II) solution 1.0mg/ml
(Pure Copper metal & hot plate)

Detection range 0.02 to

5.0mg/l

75

c) Atomic Absorption
Method (Chelation
Extraction)

Detection range 0.002

to 0.5 mg/l

d) Differential
Pulse Anodic
Stripping
Voltametry
Detection range 0.01 to
0.1mg/l

ii) IS 3025 (P 2)
:2004

Atomic Absorption Spectrophotometer with

air-acetyleneflame

Copper Hollow Cathode Lamp

Separating Funnel
Volumetric Flasks
Distillation Assembly

Hydrochloric Acid, Conc.

Nitric Acid, Conc.
Pyrrolidine
Dithiocarbamic acid
Methyl Isobutyl Ketone, AR grade
Carbon Disulphide
Sodium Hydroxide
Distilled water
Water Standard MIBK
Bromophenol Blue
Ethanol or Isopropanol
Stock copper (II) solution 1.0mg/ml
(Pure Copper metal & hot plate)

Polarograph capable of Performing differential

pulse work
Hanging Mercury Drop electrode
Platinum Counter Electrode
Saturated Calomel Reference Electrode
Magnetic Stirrer Control unit with Stirring Bar
Scrubber Assembly
Whatman Filter Paper No. 40
Nitrogen Gas

Induction Coupled Plasma-Atomic Emission

Spectrometer
Sample Bottles
Glasswares
Acid Dispensers
Membrane Filtration Equipment and Filters
(0.45)
Hot Plate
Argon Gas

Hydrochloric Acid Conc. (Spectro

Grade)
Nitric Acid-Conc. (Spectro Grade)
Sulphuric Acid Conc.
Pure Copper Metal
Granular Zinc
Mercury

Nitric Acid
Hydrogen Peroxide
Sulphuric Acid
Hydrochloric acid
Ammonium Sulfate
Stock Solution of Copper

76

3.

Iron

5.2, Sl. No
iii) of Table 2

i) IS 3025 (P 53) :2003

a) 1,10 Phenanthroline
Method

Spectrophotometer
Std. volumetric glass wares
Hot Plate
Fuming Hood
0.45 m Membrane Filter with
Filtration Assembly

i) Detection range
0.075 to 0.5mg/l

Detection range 0.1 to

10 mg/l

Ammonium Meta Vanadate

Distilled water
Hydrochloric Acid-Conc. (Containing less
than 0.00005% iron)
Hydroxylamine Hydrochloride
Ammonium Acetate
Glacial Acetic Acid
Sodium Acetate
1,10 Phenanthroline Monohydrate
Stock Iron Solution 1ml=200g of Fe
(Conc. Sulphuric Acid, Ferrous
Ammonium Sulphate, Potasssium
Permanganate)
Std. Iron Solution (1.0 ml=1.0g of Iron)
Di-isopropyl Ether

ii)This requirement is
not applicable for
Packaged Natural
Mineral Water

b) Atomic Absorption
Method (DIRECT)

Amalgamated Zinc (Granular Zinc and

Mercury)

Atomic Absorption Spectrophotometer

Air Acetylene Flame
Iron Hollow Cathode Lamp or
Electrodeless discharge lamp for use at
248.3nm
Volumetric Flasks

Distilled water
Hydrochloric Acid, Conc.
Nitric Acid, Conc.
Sulphuric Acid, Conc.
Calcium Chloride Solution (Calcium
Carbonate, Hydrochloric acid)

Stock Iron Solution (1.0 ml=100g of Fe)

(Pure iron wire, Hydrochloric acid Nitric
Acid)

77

ii) IS 15303:2003
Electrothermal Atomic
Absorption
Spectrometric Method

Minimum detection
limit 0.001mg/l

iii) IS 3025 (P 2):2004

4.

Manganese

5.2, Sl. No.

iv), Table 2

i) IS 3025:2006 Part 59
a) Periodate
Colorimetric Method

Detection limit up
to 0.2mg/l

Atomic Absorption Spectrometer

Hollow Cathode lamp for Iron
Graphite Furnace
Readout Mechanism
Sample Dispenser
Vent for fumes
Cooling device
Membrane Filter, 0.45m

Induction Coupled Plasma-Atomic Emission

Spectrometer
Sample Bottles
Glasswares
Acid Dispensers
Membrane Filtration Equipment and Filters
(0.45)
Hot Plate
Argon Gas

Nesslers Tubes
Beakers
Hot Plate
Volumetric flask
Pipettes
Conical Flasks
Burette

Metal free water

Hydrochloric Acid, Conc.
Nitric Acid, Conc.
Matrix Modifier stock solutions
(Magnesium Nitrate, Nickel Nitrate,

Phosphoric Acid, Palladium Nitrate &

Citric Acid)

Stock iron Solution 100g/ml (Iron

wire)
Sodium hydroxide 10N
Chelating resin

Nitric Acid
Hydrogen Peroxide
Sulphuric Acid
Hydrochloric acid
Ammonium Sulfate
Stock Solution of Iron

Sulphuric Acid
Hydrogen Peroxide (30%)
Nitric Acid, Conc.
Stabilized Distilled Water OR
Distillation Assembly, OR
Distilled water,
Potassium Permanganate and
Dil Sulphuric Acid
Phosphoric Acid (sp. Gr. 1.75)
Potassium Periodate
Std. Manganese Solution
(1ml=0.02 mg of

78

Mn) (Standard 0.1 N Potassium

Permanganate solution, saturated
solution of sulphur dioxide)

b) Formaldoxime
Spectrometric Method
Detection limit
between 0.01mg/l to 5
mg/l

ii) IS 3025 (P 2):2004

5.

Nitrate (as
NO3)

5.2, Sl. No.

v) of Table 2

IS 3025 (Part 34):1988

i) Cadmium Reduction
Method

Spectrophotometer
Glass Bottle
Autoclave

Induction Coupled Plasma-Atomic Emission

Spectrometer
Sample Bottles
Glasswares
Acid Dispensers
Membrane Filtration Equipment and Filters
(0.45)
Hot Plate
Argon Gas

Reduction Column
Colorimeter OR
Spectrophotometer OR
Filter photometer
Glass wool
0.45 m pore diameter membrane filter
Refrigerator

Fluoride Free Water

Potassium Peroxodisulphate or Sodium
Peroxodisulphate
EDTA Tetrasodium Salt, Solution, c(EDTA)
Sodium Hydroxide
Hydroxylammonium Chloride
Formaldehyde
Ammonia Solution
Ammonium Iron (II) Sulphate Hexahydrate
Solution
Sulphuric Acid, conc.
Manganese Monohydrate (for Standard Mn
Solution)

Nitric Acid
Hydrogen Peroxide
Sulphuric Acid
Hydrochloric acid
Ammonium Sulfate
Stock Solution of Iron

Distilled water
Nitrate free water
Cadmium granules (40 60 mesh)
Hydrochloric Acid (6N)
Copper Sulphate Solution
Sulphanilamide
Conc. Hydrochloric Acid
N-(1-napthyl))-Ethylenediamine

79


Detection limit
maximum 0.1 mg/l

ii) Chromotropic Acid

Method

Chloroform
Stock nitrite solution - 100g/ml
(Potassium Nitrite & Chloroform)

Nitrite free water

Nitrate free water

Stock Nitrate Solution - 100g/ml
(Potassium Nitrate, Chloroform)

Spectrophotometer
Standard laboratory glasswares

Detection range 0.1 to

5.0mg/l

Standard Nitrate solution 10.0g/ml

Sulphite Urea Reagent
(Urea & Anhydrous sodium Sulphite)

Antimony reagent (Antimony metal,

Conc. Sulphuric acid)

Chromotropic Acid Reagent (Purified

chromotropic Acid crystals, Conc.
Sulphuric Acid)
Sulphuric Acid, Conc. Nitrate free

iii) Devardas Alloy

Reduction Method
Detection limit
minimum 2 mg/l

Distillation Assembly (Kjeldahl

Assembly)
Measuring Scoop
Spectrophotometer

dihydrochloride (NED) Dihydrochloride)

Ammonium Chloride
Disodium Ethylene diamine tetra acetate
Ammonia Solution
Copper sulphate Solution 2%
Stock nitrate solution 100g/ml
(Potassium Nitrate & Chloroform)

Ammonia Free Water

Borate Buffer Solution (0.1N Sodium
Hydroxide, 0.025M Sodium Tetraborate)
Sodium Hydroxide 6 N
Devardas Alloy 20 mesh with less than

80

0.005 percent Nitrogen

Mixed indicator Solution (Methyl Red

indicator, Ethyl alcohol/Isopropyl alcohol,
Methylene Blue)

Indicating Boric Acid Solution

(Hydroboric Acid, mixed indicator
solution)
Std. Sulphuric Acid Titrant - 0.02 N
Nesslers Reagent (Mercuric Iodide,
Potassium Iodine. Sodium Hydroxide)
Stock Ammonia Solution -1.22mg
ammonia/ ml (Anhydrous Ammonium
Chloride)
Standard Ammonia Solution
Nitrite Free water (Distilled water,
Potassium Permanganate, Barium
Hydroxide/Calcium Hydroxide Conc.
Sulphuric Acid, Manganese Sulphate)

6.

Nitrite

5.2, Sl. No.

vi) of Table
2

IS 3025(P 34) :1988

Spectrophotometer / Photometer
OR

Nesslers cylinders method

Nesslers Tubes
0.45 m Membrane Filter
Distillation Assembly (borosilicate)

Sulphanilamide Reagent
NED Dihydrochloride
Hydrochloric Acid
Sodium Oxalate 0.05 N.
Ferrous Ammonium Sulphate 0.05N
(Ferrous Ammonium Sulphate, Conc.
Sulphuric Acid, Std. Dichromate solution)
Stock Nitrite Solution - 250g of
nitrogen/ml (Sodium Nitrite, Chloroform,
Sodium Oxalate, Std., Potassium
Permanganate solution)
Intermediate Nitrite Solution 50.0g/ml
Standard Nitrite Solution 0.500g/ml

81

7.

Flouride

5.2, Sl. No.

vii) of Table
2

Clause 23 of
IS 3025:1964
i) Zirconium alizarin
Method

Nessler Tubes (100ml)

Distillation Apparatus
Refrigerator (Recommended)
Heating mantle

Detection range
0.05 to 1.0 mg/l

ii) Electro Chemical

Probe Method

Detection range
0.2mg to 2.0 g/l

Sodium Thiosulphate Solution (0.1 N)

Standard Sodium Fluoride Solution (1ml =
0.01 mg F)
Zirconium Oxychloride OR Zirconium
Oxynitrate
Alizarin Sodium Monosulphonate (Alizarin
S)
Conc. Hydrochloric Acid
Conc. Sulphuric Acid
Silver Sulphate
Perchloric Acid
Phenolphthalein Indicator
Sodium Hydroxide Solution

Millivolt Meter

Sodium Hydroxide- 5 M

Fluoride Ion Selective Electrode

Reference Electrode Either a calomel electrode,
filled with saturated Potassium Chloride (KCl)
Solution or a Silver / Silver Chloride Electrode

Total Ionic Strength Adjustment Buffer

(TISAB)-[Sodium Chloride, Glacial Acetic Acid,
Sodium Hydroxide, CDTA( trans -1,2diaminocyclohexane N,N,N,N tetra acetic
acid)]

easuring Cells 100ml(Polypropylene fitted

with thermostated jacket )

Fluoride, Stock Solution, 1000mg/1 (Sodium

Fluoride )

Water Bath
agnatic Stirrer with a
polytetrafluoroethylene(PTFE)
Polyethylene Beaker
Note :
pH meter
Standard Volumetric Glasswares

Purity of the reagent Unless specified

otherwise, only pure chemicals & Fluoride free
distilled water shall be used in tests.

Desiccator

82

Screw Capped Polyethylene Container

Plastic Bottle

8.

Zinc

5.2, Sl. No.

viii) of Table
2

IS 3025 (P 49): 1994

with Am 1

Spectrophotometer (620 nm with 1cm cells)

i) Zincon Method

Detection range 0.02 to

5 mg/l

ii) Atomic Absorption

Method (Direct)

Atomic Absorption Spectrophotometer with

Air-Acetylene Flame
Hollow Cathode Lamp
Or Electrodeless discharge lamp

Sodium Hydroxide
Potassium Cyanide
Cyclohexanone
Distt. Water
Zincon
Methanol
Sodium Ascorbate
Borate Buffer Solution (Sodium
Hydroxide, Potassium Chloride, Boric
Acid)
Hydrochloric Acid, Conc.
Zinc Sulphate

Hydrochloric Acid, Conc.

Nitric Acid, conc.
Stock Zinc Solution 1.0mg/ml (Zinc
Granules/Zinc Oxide)

Detection range 0.01 to

2.0mg/l

iii)Atomic Absorption
Method (Chelation
Extraction)
Detection range 0.001
to 0.2mg/l

Atomic Absorption Spectrophotometer with

Air-Acetylene Flame
Hollow Cathode Lamp

Hydrochloric Acid, Conc.

Nitric Acid, Conc.
Pyrrolidine Dithio Carbamic Acid Chloroform Reagent (Pyrrolidine,
Chloroform, Carbon disulphide)
Sodium Hydroxide
Chloroform

83

iv) Differential Pulse

Anodic Stripping
Voltammetry
(DPASV)Method
Detection range 0.001
to 0.1mg/l

9.

Silver

5.2, Sl. No.

ix) of Table 2

Annex J of
13428:2005

IS

Polarographic Instrumentation
Capable of Performing Differential
Pulse Work
Hanging Mercury Drop Electrode
Platinum Counter Electrode
Saturated Calomel Reference
Electrode
Magnetic Stirrer
Atomic Absorption Spectrophotometer
with Oxidizing Air Acetylene Flame

Bromophenol Blue Indicator

(Bromophenol Blue, Ethanol or
Isopropanol)
Stock Zinc (II) Solution- 1.0 mg/ml (Zinc
Granules or Zinc Oxide, Nitric Acid)

Hydrochloric Acid, Conc.

Nitric Acid, Conc
Stock Zinc Solution -1.0mg/ml
Amalgamated Zinc (Granular Zinc, Conc.
Hydrochloric Acid, Mercury)
Purified Nitrogen (Ammonium Meta
Vanadate, Scrubber, Amalgamated Zinc,
Nitrogen Gas)
Deionised Distilled Water (Ion Exchange
Column & Distilled Water)
Nitric Acid Redistilled
Hydrochloric Acid Redistilled
Silver Std. Solution (Silver Nitrate)
Lanthanum Chloride
Lanthanum Stock Solution (Lanthanum
Oxide, Hydrochloric Acid)
Ammonium Pyrrolidine Dithiocarbamate
solution)
Methyl isobutyl ketone

84

10.

Aluminium

5.2, Sl. No.

x) of Table 2

i) IS 3025(P 55): 2003

a) Eriochrome Cyanine
R Method

Spectrophotometer (535 nm with 1cm Cells)

pH Meter
Standard Volumetric Glasswares

i) Detection range
0.02 to 0.3mg/l;

ii) This requirement is

not applicable for
Packaged Natural
Mineral Water

b) Atomic Absorption
Method (Direct)

Sulphuric Acid 0.02 N and 6 N

Ascorbic Acid Solution
Buffer Solution (Sodium Acetate & 1 N
Acetic Acid)
Acetic Acid Solution 1:1 and 1 N
Sodium Hydroxide Solution 0.1 N and
1N
Stock Eriochrome Cyanine R Dye Solution
Stock Aluminium Solution 500 g/l
(Aluminium Potassium Sulphate)
Methyl Orange Indicator Solution

Atomic Absorption Spectrophotometer with

Nitrous Oxide Acetylene Flame and
Hollow-Cathode Lamp
Standard Volumetric Glasswares

Hydrochloric Acid, Conc.

Nitric Acid, Conc.
Potassium Chloride Solution
Stock Aluminium Solution - 500 g/l
(Aluminium Potassium Sulphate)

Atomic Absorption Spectrometer

Burner
Read Out Mechanism
Lamp (Hollow Cathode or EDL)
Pressure Reducing Valves
Vent
Nitrous Oxide Burner Head
T-Junction Valve or Other Switching Valve

Air (Compressor or Bottled Gas)

Acetylene, Standard Commercial Grade
Nitrous Oxide Gas

Metal Free Meter

Hydrochloric Acid 1 N
Nitric Acid, Conc.
Sulphuric Acid
Hydrofluoric Acid 1 N
Potassium Chloride
Aluminium Nitrate
Standard Aluminium Solution - 100 g/l
(Aluminium Metal)

Detection range 5 to
100mg/l
ii) IS 15302:2003 Direct
Nitrous Oxide
Acetylene Flame
Atomic Absorption
Spectrometry
Detection limit 0.1mg/l

85

11.

Chloride

5.2, Sl. No
.xi) of Table
2

IS 3025 (P32): 1988

i) Argentometric
Method

Erlenmeyer Flask (250ml)

Burette

ii) Mercuric Nitrate

Method

Erlenmeyer Flask (250 ml)

Microburette (5 ml with l.c. 0.01ml)
Refrigerator
pH meter

iii) Potentiometric
Method

Glass and Silver- Silver Chloride Electrodes

Electronic Voltmeter
Mechanical Stirrer

Potassium Chromate Indicator Solution

(Potassium Chromate, Silver Nitrate)
Standard Silver Nitrate Solution 0.01 N
(silver nitrate, sodium chloride)
Standard Sodium Chloride Solution 0.01
N (Sodium Chloride)
Aluminium Hydroxide Suspension
(Aluminium Potassium Sulphate or
Aluminium Ammonium Sulphate, Conc
Ammonium Hydroxide)
Phenolphthalein Indicator Solution
Sodium Hydroxide 1N
Sulphuric Acid 1N
Hydrogen Peroxide 30%

Standard Sodium Chloride Solution,

0.01N
Nitric Acid, 0.1N
Sodium Hydroxide, 0.1N
Indicator Acidifier Reagent (SDiphenyl- carbazone, Conc. Nitric Acid,
Xylene Cyanol FF, Ethyl Alcohol or
Isopropyl Alcohol)
Standard Mercuric Nitrate Solution, 0.01N
(Mercuric Nitrate, Conc. Nitric Acid,
Sodium Bicarbonate, Std. Sodium
Chloride Solution)
Mixed Indicator Reagent
(Diphenylcarbazone, Bromo Phenol Blue,
Ethyl Alcohol or Isopropyl Alcohol)
Standard Mercuric Nitrate Solution 0.1N

Standard Sodium Chloride Solution

(0.01N)
Nitric Acid-Conc

86

iv) Automated
Ferricyanide Method

Automated Analytical Equipment

Filters (480nm)

Standard Silver Nitrate Solution (0.01N)

Pretreatment Reagent (Sulphuric Acid,
Hydrogen Peroxide, Sodium Hydroxide
1N)

Stock Mercuric Thiocyanate Solution

(Mercuric Thiocynate, Methanol)
Stock Ferric Nitrate Solution (Ferric
Nitrate, Conc. Nitric Acid)
Colour Reagent (Poly oxy Ethylene 23
Lauryl Ether)
Sodium Chloride

12

Selenium

5.2, Sl. No.

xii) of Table
2

i) IS 3025 (P56): 2003

a)Spectrophotometric
Method
(Diamino naphthalene
method)

Detection limit
minimum 0.01mg/l

b) Atomic Absorption
Spectrometric Method
(Hydride Technique)

Spectrophotometer (480nm,light path of 1

cm
Volumetric Glasswares
Separating Funnel (250ml) Preferably
Flourocarbon Stopcock
Water Bath Thermostatically Controlled
pH Meter
Centrifuge
Centrifuge Bottles with Flourocarbon Screw
Cap

Atomic Absorption Spectrometer ( 196.0

nm) Fitted with Hydride System and Hollow
Cathode Lamp/Electrodeless Discharge
Lamp
Gas (Argon or Nitrogen)
Glasswares Decomposition Apparatus
(Round Bottom Flask, Reflux Condenser,
Condensate Reservoir)

Stock Selenium Solution 1.0mg/ml

(Sodium Selenite, Hydrochloric Acid)
Hydrochloric Acid 0.1N
Ammonium Hydroxide,1:1Cyclohexane
2,3 Diaminonaphthalene (DAN)
Hydroxylamine Hydrochloride
Sodium Salt of EDTA
Amberlite XAD -8 or Equivalent Resin
Hydrochloric Acid, Conc
Potassium Hydroxide

Nitric Acid
Sulphuric Acid
Hydrochloric Acid
Hydrogen Peroxide
Sodium Hydroxide
Sodium Tetrahydro borate
Selenium Stock Solution (1mg/ml)
(Selenium Dioxide)

87

ii) IS 15303:2003
Electrothermal Atomic
Absorption
Spectrometric Method
Detection limit
minimum 0.002mg/l

13

Sulphate

5.2, Sl. No.

xiii) of Table
2

Atomic Absorption Spectrometer

monochromator or filter and adjustable slit
Hollow Cathode Lamp or Electrodeless
Discharge Lamp
Graphite Furnace
Photoelectric Detector
Readout Mechanism
Sample Dispenser
Vent for Fumes
Cooling Device
Membrane Filter Apparatus (0.45 m)
Argon Gas

Metal Free Water

Hydrochloric Acid, Conc
Nitric Acid, Conc
Matrix modifier Stock Solutions
(Magnesium Nitrate, Nickel Nitrate,
Phosphoric Acid, Palladium Nitrate, Citric
Acid)
Stock Metal Solution 1mg/ml (Sodium
Selenite)
Chelating Resin 100 to 200 mesh

IS 3025 (P24): 1986

i)Gravimetric Method
Detection limit more
than 10mg/l

ii) Thorin Method

Detection range 5 to
150mg/l

Steam Bath
Drying Oven (thermostatically controlled)
Muffle Furnace
Desiccator
Analytical Balance (l.c.0.1mg)
Filter Paper (Preferably Whatman No.42)
Silica or Porcelain Crucible (max pore size
of 5 microns)
Ion Exchange Column
Filter (0.45 m)
Platinum Dish

White Porcelain Basin

Burette
Ion Exchange Column
Filter 0.45m

Methyl Red Indicator

Hydrochloric Acid
Barium Chloride
Silver Nitrate
Nitric Acid
Ion Exchange Resin (Amberlite IR-120 or
Equivalent)

Ethyl Alcohol
Ammonium Hydroxide (Ammonia-Conc

and Distilled Water)

Hydrochloric Acid

Thorin (2,2 Hydroxy 3,6 Disulpho

1 Naphthylazo Benzene Arsenic Acid)

88

Ion Exchange Resin (Amberlite

IR-120 or Equivalent)

Stock Sulphate Solution 100 mg/l

(Anhydrous Sodium Sulphate)

iii)Turbidity Method

Turbidity Meter or Spectrophotometer`(420

nm)
Glass Apparatus
Hot Plate
Refrigerator (recommended)
Filter 0.45m

pH Meter
Burette
Magnetic Stirrer Assembly
Beaker

Distilled Water
Sulphuric Acid, Conc
Sulphuric Acid, 0.02 N
Phenolphthalein Indicator
Mixed Indicator Solution (Methyl Red,
Bromocresol Green, Ethyl or Isoprophyl
Alcohol)

Potentiometer
Glasswares

Standard Sulphuric Acid 0.02N

Detection limit 1 to
40mg/l

14

Alkalinity

5.2, Sl. No.

xiv) of

IS 3025 (P 23): 1986

with Amendment 1& 2

Table 2

i) Indicator Method
Detection range 0.5 to
500mg/l

ii)Potentiometric
Method

Barium Chloride Standard Solution

(Barium chloride in hydrochloric acid
ammonia)
Barium Chloride
Gelatin Powder
Glycerol
Hydrochloric Acid, Conc
Sodium Chloride
Ethyl or Isopropyl Alcohol
Anhydrous Sodium Sulphate
Stock sulphate solution 100mg/l

Detection range 0.5 to

500mg/l

89

15

Calcium

5.2, Sl. No.

xv) of Table
2

i) IS 3025 (P40): 1991

with Amendment 1

a)EDTA Titrimetric
Method

Hot Plate
Glasswares
Polyethylene Bottle

Sodium Hydroxide Solution 1N

Hydrochloric Acid 0.1N
Indicator Solution:Murexide (Ammonium
Purpurate) Indicator, Absolute Ethylene
Glycol Sodium Chloride
OR

Patton and Reeders Indicator (Eriochrome

Blue Black R, Sodium Sulphate/Potassium
Sulphate)

Standard EDTA Solution 0.01M

(Disodium Ethylene Diamine Tetra
Acetate, Standard Zinc Solution, (Or Standard
Calcium Solution) Buffer Solution,
Eriochrome Black T Indicator Solution

b)Atomic Absorption
Spectrometric Method

Atomic Absorption Spectrometer (422.7 nm )

with Air/Acetylene or Nitrous Oxide/Acetylene
Flame and Hollow Cathode Lamp (Calcium)

Detection limit
maximum 50mg/l

c) Permanganate
Titration Method

Beakers, Cover Glass, and Glass Rod

Filtration Set up (Gooch Crucible with
Suction)
Hot plate

Stock Calcium Solution (Calcium

Carbonate, Hydrochloric Acid 0.1N)
Nitric Acid, Conc

Hydrochloric Acid 1N and 0.1N

Lanthanum Chloride
Cesium Chloride
Standard Calcium Solution

Hydrochloric Acid 1N
Methyl Red Indicator Solution
Ammonium Oxalate Solution
Urea
Dilute Sulphuric Acid 1N
Sodium Oxalate
Standard Potassium Permanganate
Solution (Potassium permanganate,
sodium oxalate)

90

ii)IS 3025(Part 2)
Inductively Coupled
Plasma Atomic
Emission Spectroscopy
(a e s)

ICP AES ( 315.887 nm) including -

computer controlled a e s with background

correction

radio frequency generator

argon gas supply ( welding grade or better)

Sample bottles

Glassware ( beakers, filter funnels,

volumetric flasks, pipettes)

acid dispensers

Membrane filtration equipment

filter of pore size 0.45 microns

Nitric Acid
Hydrogen Peroxide
Sulphuric Acid
Hydrochloric Acid
Ammonium Sulphate
Distilled Water
Calcium Stock solution ( 10 mg/l )

Detection limit
0.1 mg/l

16

Magnesium

5.2, Sl No.
xvi) of Table
2

i) IS 3025 (P 46): 1994

with Amendment 1 & 2

a)Gravimetric Method
Detection limit more
than 1 mg/l

Vacuum Pump
Filter Flasks
Filter Crucibles ( medium porosity, 30 ml)
Muffle Furnace

Methyl Red Indicator

Hydrochloric Acid
Ammonium Oxalate
Ammonium Hydroxide
Nitric Acid, Conc
Diammonium Hydrogen Phosphate
Urea

91

-Hot plate
-Volumetric Flasks
-Glasswares
b) Volumetric Method
(EDTA)

Indicator Solutions
i) Patton and Reeder Reagent, Sodium
Chloride/Potassium Chloride
ii)Murexide (Ammonium Purpurate), Absolute
Ethylene Glycol, Sodium Chloride
iii)Eriochrome Black T Indicator (EBT
Indicator), Hydroxylamine Hydrochloride,
Ethanol/Methanol

c)Atomic Absorption
Spectrophotometric
Method

Detection limit max 5

mg/l

Atomic Absorption Spectrophotometer (

285.2 nm ) with Air-Acetylene Flame or
Nitrous
Oxide-Acetylene Flame and Hollow
Cathode Lamp (Magnesium)
Polyethylene Bottles

Standard Zinc Solution 0.01M (Pure

Zinc Dust/Granules 99.9% Pure;
Hydrochloric Acid)
Buffer Solution (Ammonium Chloride,
Ammonia, Sodium Hydroxide-1N)
Standard Ethylene Diamine Tetra Acetic
Acid (EDTA) Solution 0.001M
(Disodium Ethylene Diamine Tetra
Acetate Dihydrate, Standard Zinc
Solution)
Triethanolamine Solution 10%
Potassium Cyanide
Hydroxlamine Hydrochloride

Hydrochloric Acid 1N and 0.1N

Lanhanum Chloride (Lathanum Oxide,
Hydrochloric Acid, Conc)

Cesium Chloride
Standard Magnesium Solution (1000mg/l)
(Magnesium Oxide, Hydrochloric
Acid)

92

ii) IS 3025(Part 2)
Inductively Coupled
Plasma Atomic
Emission Spectroscopy
Detection limit
0.03 mg/l

17

Sodium

5.2, Sl No.
xvii) of Table
2

ICP AES (279.079nm) including computer controlled aes with background

correction
radio frequency generator
argon gas supply ( welding grade or better)
Sample bottles
Glassware ( beakers, filter funnels,
volumetric flasks, pipettes)
acid dispensers
Membrane filtration equipment

Nitric Acid
Hydrogen Peroxide
Sulphuric Acid
Hydrochloric Acid
Ammonium Sulphate
Distilled Water
Magnesium Stock solution ( 10 mg/l )

i) IS 3025 (P45): 1993

with Amendment 1
a)Flame Emission
Photometric Method

anyone of the
following applicable
detection range:(0 to
1)mg/lit(1 to
10)mg/lit (0 to
100)mg/lit

Flame Photometer (Direct Reading OR

Internal Standard Type) OR Atomic

Absorption Spectrophotometer (In

Flame Emission Mode)

Deionized Distilled Water

Stock Sodium Solution 1mg/ml (Sodium
Chloride)
Standard Lithium Solution 1mg/ml

Glasswares

pH meter
Weighing balance

b)Atomic Absorption
Spectrometry Method
Detection range 0.20 to
4.0mg/l

Atomic Absorption Spectrophotometer

with Air-Acetylene Flame and Hollow
Cathode Lamp (Sodium)

Sodium Chloride
Potassium Chloride
Stock Sodium Solution 1mg/ml
Stock Potassium Solution 1mg/ml

93

c)Gravimetric Method

Glassware
Beakers (20ml, Borosilicate)
Fritted Glass Crucible or Porous Porcelain
Crucibles
Vacuum Pump or Aspirator

Filter paper
Pyrex bottle
Stirring rod
ii) IS 3025(Part
2):2004

18

Residual
Free
Chlorine

5.2, Sl No.
xviii) of
Table 2

Oven
Membrane filtration equipment and
filters(0.45m)
Inductively coupled plasma atomic emission
spectrometer; Computer controlled AAS with
background correction, Radiofrequency
Generator, Argon Gas supply(welding grade or
better)
pH meter
PTFE container
PTFE sample bottles(250 ml or 500ml)
Acid dispensers, Variables

Zinc Uranyl Acetate Reagent (Glacial

Conc. Acetic Acid, Uranyl Acetate
Dihydrate, Zinc Acetate Dihydrate,
Sodium Chloride)
Ethyl Alcohol Wash Solution (Ethyl
Alcohol, Pure Sodium Zinc Uranyl
Acetate, Sodium Chloride, Acetic Acid,
Diethyl Ether)

Nitric acid
Hydrogen peroxide
Sulphuric acid
Hydrochloric acid
Ammonium sulphate
Sodium Stock solution

IS 3025 (P 26): 1986

Stabilized Neutral
Ortho-Toluidine Method

Spectrophotometer ( w i t h l i g h t p a t h
of 1c m c ell or longer f or
1 mg/ l)
This requirement is not Magnetic Stirrer Assembly
applicable for PNMW
Refrigerator (Recommended)
Detection range 0.005
to 0.01mg/l

Distilled Water Chlorine Demand Free

(Distilled Water, Chlorine)
Neutral Ortho-Toluidine Reagent
(Hydrochloric Acid Conc, Mercuric
Chloride, Disodium Salt of EDTA

94

pH meter

Dehydrated, Ortho-Toluidine
Dihydrochloride Buffer Stabilizer
Reagent (Dipotassium Hydrogen
Phosphate, Potassium Dihydrogen
Phosphate, Di (2-Ethyl Hexyl)
Sulphosuccinate, Diethylene Glycol
Monobutyl ether

Brown Glass Stoppered Bottles

Potassium Iodide Solution (Potassium

Iodide
Sulphuric Acid Conc. Sodium Carbonate
Sodium Arsenite
Standard Chlorine Solution (Chlorine Gas
&
Distilled Water OR Hypochlorite
Solution) Sodium Thiosulphate Solution
0.025N)
20

Mineral Oil

5.2, Sl No
.xx) of Table
2

IS 3025 (P 39): 1991

with Amendment 1

Partition Infra-Red
Method

Detection limit 0.5 to

100 mg/l

Separating Funnel (1lit) with Teflon or

Equivalent Stopcock
Infra-Red Spectrophotometer Double
Beam, Recording type
Cells Infra-Red, Silica
Filter Paper Whatman No.40 or
Equivalent, 11cm Diameter
Analytical Balance

Hydrochloric Acid
Hexane
Sodium Sulphate, Anhydrous
Reference Oil (Iso-Octane, Hexadecane,
Benzene)
Trichlorotrifluoroethane

95

21

Anionic
Surface
Active
Agents (as
MBAS)

5.2, Sl No.
xxi) of Table
2

Annex K of

IS 13428:2005

Detection limit about

0.05 mg/l

pH Meter
Spectrophotometer (650 nm) 10mm &
50mm cells
Gas Stripping Apparatus (1 lit Capacity)
Nitrogen Air (20 ltr/hr to 50 ltr/hr)
Reflux Condenser
Fume hood
Water bath

22

Sulphide

5.2, Sl. No.

xxii) of Table
2

IS 3025 (P 29): 1986

i) Iodometric Method

Detection limit above 1

mg/l

Glass Fibre Filter Paper.

Reaction Flask (1 lit capacity with 2
holestopper fitted with gas-diffusion
tube.
Absorption flasks (250ml Capacity) (2
Nos)
Nitrogen/Carbon dioxide gas cylinder
Or Carbon dioxide gas generator

ii) Methylene blue

method
Detection limit upto 20
mg/l

Spectrophotometer (664 nm) or

filterphotometer (600 nm).
Matched test tubes

Sodium Chloride
Ethyl Acetate
Al2O3
Chloroform
Ethanol
Methanol
Sulphuric Acid
Ethanolic Sodium Hydroxide-0.1
mol/lit (Sodium Hydroxide, Ethanol)
Methylene Blue, Neutral Solution
Methylene Blue, Acidic Solution
Bufer Solution, pH 10 (Sodium
CHydrogen Carbonate, Anhydrous
Sodium Carbonate)
Phenolphthalein Indicator, Ethanol
Dodecyl Benzene Sulphonic Acid Methyl
Ester (Tetrapropylene Type), Stock
Standard Solution
Zinc acetate solution 2N
Sulphuric Acid, Conc.
Standard Iodine solution 0.025 N
(Potassium Iodide, Iodine)
Hydrochloric Acid, Conc.
Standard Thiosulphate Solution - 0.025
N (Sodium thiosulphate, Sodium
Hydroxide/Chloroform)
Starch indicator solution (Starch, salicylic
acid, toluene)
Aluminium Chloride solution 6N
Sodium hydroxide 6N

N, N-dimethyl-p-Phenylene Diamine
oxalate

Sulphuric Acid, Conc. & 1:1 solution

96

23

Antimony

5.2 Sl. No.

xxiii) of
Table 2

Droppers
Dark glass bottle.

Ferric Chloride
Diammonium Hydrogen Phosphate
Methylene Blue
Standard Sulphide Solution
Zinc acetate

i) Annex G of
IS 13428:2005
Spectrophoto-metric
Method

Spectrophotometer (565 nm)

Erlenmeyer Flask (125ml)
Seperating Funnels (125 ml) with Teflon
Stopcocks
Refrigerator
Ice Bath
Test Tubes
Pipettes

Hydrochloric Acid 6 N
Phosphoric Acid 3N
Rhodamine B

Antimony Standard Solution (100

g/ml and 1 ug/ml (pure antimony,
sulphuric acid)

Benzene

ii) IS 15303:2003

Electrothermal
Atomic Absorption
Spectrometric Method

Sulphuric Acid
Perchloric Acid

Metal free Water

Hydrochloric Acid, Conc.
Nitric Acid, Conc.
Matrix
Modifier
Stock
Solutions
(Magnesium Nitrate, Nickel Nitrate,
Phosphoric Acid, Palladium Nitrate, Citric
Acid)
Stock MetalSolution

Antimony Solutions (100 g/m Sb)

Iron-100g Fe
Selenam-1.00 mg Sb
Chelating Resin
Sodium hydroxide -10 N

Atomic Absorption Spectrometer with

Hollow Cathode Lamp OR

Electrodeless discharge lamp (EDL).
Graphic Furnace
Readout Mechanism
Microlitre Pipettes-5 to 100 l. OR
Automatic sampling device designed
for the specific instrument.
Vent for Fumes
Cooling Device
Membrance Filter Apparatus
(0.45m) or smaller pore diameter
membrane filters.

97

24

Borates

5.2, Sl. No.

xxiv) of
Table 2

Annex H of
13428:2005

IS

Spectrometer (410 420nm)

Lab Apparatus made of
Polypropylene/Polyethylene/Polytetrafluoro
Ethylene
Refrigerator

Azomethine H, Sodium Salt

L + - Ascorbic Acid
Buffer Solution (pH 5.9) [Ammonium
Acetate, Sulphuric Acid, Phosphoric Acid,
Citric Acid, Disodium Ethylene diamine
Tetraacetic Acid Dihydrate]
Borate Stock Solution - (1mg/ml) (Boric
Acid)
Boron Standard Solution - 10g/ml
Calcium Hydroxide

98

C - REQUIREMENTS FOR TOXIC SUBSTANCES

MERCURY
1

5.2, Sl.
No. i)
of
Table 3

IS 3025 (P 48): 1994

with Amendment 1

i) Cold Vapour
Atomic Absorption
Spectrophotometry

Atomic Absorption Spectrometer and Associated

Equipment (Cold Vapour Technique)
Mercury Vapour Generation Assembly
Mercury Hollow Cathode Lamp
Recorder/Printer/Display Meter
BOD bottle, 300 ml
Water bath
Equipment assembly as per Fig 1

Spectrophotometer
Separating Funnels (250 and 1000ml with PTFE
stopcocks)
Glass wares
Whatman Filter No. 42

Redistilled or Deionised Distilled Water

(Mercury free)
Mercuric chloride
Nitric acid, Conc.
Potassium permanganate
Potassium persulphate
Hydroxylamine hydrochloride
Dithiozone solution, 6 g/ml
Sulphuric acid 0.25 N
Potassium bromide
Chloroform
Disodium hydrogen phosphate
Anhydrous potassium carbonate
Sodium sulphate, Anhydrous
Hydrochloric acid (1:1)
Ammonium hydroxide

Detection limit
0.0002 mg/l, Min

ii) Colorimetric
Dithizone Method
Detection limit
0.002 mg/l, Min

Sulphuric acid, conc.

Nitric acid, Conc.
Stannous chloride
Hydrochloric acid, Conc.
Sodium chloride
Hydroxylamine sulphate
Potassium permanganate
Potassium persulphate
Mercuric chloride
Mercury free distilled water

99

CADMIUM
2

5.2, Sl.
No. ii)
of
Table 3

IS 3025 (P 41): 1992

i) Atomic Absorption
Method (Direct)

Atomic Absorption spectrophotometer

with Air-Acetylene Flame
Cadmium Hollow Cathode Lamp or
Multi Element Hollow Cathode Lamp
for Use at 228.8 nm

Hydrochloric acid, Conc.

Nitric acid, Conc.
Nitric acid, dilute 1:499
Pure Cadmium Metal

Atomic Absorption spectrophotometer

with Air-Acetylene Flame
Cadmium Hollow Cathode Lamp or
Multi Element Hollow Cathode Lamp
for Use at 228.8 nm
Separating funnel
pH meter
pH paper

Hydrochloric acid, Conc.

Hydrochloric acid 1:49
Nitric acid, Conc.
Nitric acid, dilute 1:499
Pure Cadmium Metal
Sodium hydroxide
Methyl Isobutyl Ketone (MIBK)
Bromophenol Blue
Ethanol or Isopropanol
Pyrrolidine dithiocarbamic acid
Carbon Disulphide

Polarograph Capable of Differential Pulse Work

Hanging MercuryDrop Electrode
Platinum Counter Electrode
Saturated calomel Reference Electrode
Magnetic Stirrer Control Unit with Stirring Bar
Nitrogen Gas (Cylinder)
Scrubber assembly for nitrogen purification
Voltametric Cell assembly

Hydrochloric Acid, Conc., spectrograde

Nitric Acid, Conc., spectrograde
Nitric Acid, dil 1:1
Hydroxylamine Hydrochloride
L-Ascorbic Acid
Pure Cadmium Metal
Granular Zinc
Mercury
Ammonium Meta Vanadate

Atomic absorption spectrometer equipped with gas

flow meter for Argon or Nitrogen and Hydrogen
and with arsenic electrode less discharge lamp
Atomizer
Reaction cell for producing arsenic hydride
Eye dropper or syringe
Refrigerator

Argon or Nitrogen and Hydrogen

Sodium borohydride
Sodium hydroxide
Sodium Iodide
Sulphuric acid-18N & 2.5 N
Potassium persulphate
Nitric acid, conc

Detection range
0.05 to 2mg/l
ii) Atomic Absorption
Method (Chelation
and Extraction)
Detection range
0.005 to 0.2mg/l

iii) Differential Pulse

Anodic Stripping
Voltametry
Detection range
0.0001 to 0.1mg/l

ARSENIC

5.2, Sl.
No. iii)
of
Table 3

IS 3025(P 37): 1988

i) Atomic absorp tion
method
Detection limit
0.001 mg/l

100

 Perchloric acid, conc

Hydrochloric acid, conc
Arsenic trioxide
Arsenic pentaoxide
Dimethyl arsenic acid/cacodylic acid
Calcium chloride
ii) Silver diethyl
dithiocarbamate
method
(Refree method)
Detection limit
0.001 mg/l

Arsine generator & absorption assembly

(Fig 2 of
IS 3025 Pt 37)
Spectrophotometer, 535 nm with 1 cm cells

iii) Mercuric bromide

stain method

Arsine generator glass assembly (Fig 3 of IS

3025
Pt 37)

Detection limit
0.001mg /l

CYANIDE
4

5.2, Sl.
No. iv)
of
Table 3

Hydrochoric acid , Conc

Potassium Iodide
Stannous chloride, arsenic free
Lead acetate
Ephedrine
Pyridine
Chloroform
Silver diethyl dithiocarbamate
Zinc 20 to 30 mesh, arsenic free
Arsenic trioxide
Sodium hydroxide

Sulphuric acid (1:1)

Nitric acid, conc
Roll cotton
Lead acetate
Arsenic papers
Mercuric bromide
Ethyl alcohol/isopropanol
Potassium iodide
Arsenic free stannous chloride
Zinc-20 to 30 Mesh, arsenic free
Arsenic trioxide
Sodium hydroxide

IS 3025(P.27): 1986
with
Amendment 1
i) Total cyanide after
distillation method

Distillation apparatus consisting of boiling flask,

1l, thistle tube, Allihn water cooled condenser, gas
dispersion tube, needle valve, suction flask and

Sodium hydroxide
Lead carbonate-powdered
Sulphamic acid

101

Detection limit
minimum 0.02 mg/l

ii) Selective electrode

method
Detection range
0.05 to 10 mg/l
5

LEAD

5.2, Sl.
No. v)
of
Table 3

IS 3025(P 47): 1994

with
Amendment 1 & 2
i) Atomic absorption
method (direct)

suction pump (Fig 1 of IS 3025 Pt 27)

Heating mantle
Gas absorber
Ground glass ST joints
Spectrophotometer for use at 62 nm with 1-cm cell
pH paper
Thermometer 0oC 1100C, l.c. 1oC

Expanded scale pH meter or specific Ion meter

Cyanide Ion selective electrode
Reference electrode, double junction
Magnetic mixer with TFE coated stirring Bar

Atomic absorption spectrophotometer with air

acetylene flame
Hollow cathode lamp OR Electrodeless Discharge
lamp for use at 283.3 nm

Magnesium chloride
Sulphuric acid, conc
Acetic acid, glacial
Potassium cyanide
Silver nitrate
Chloramine - T
Pyridine
Pyrazolone
BIS pyrazolone

Potassium cyanide
Silver nitrate
Sodium hydroxide
Potassium nitrate
Potassium hydroxide

Hydrochloric acid, conc

Nitric acid, conc.
(Lead nitrate
Nitric acid, dil (1:499)

Hydrochloric acid, conc

Hydrochloric acid, dil (1:2)
Hydrochloric acid, dil (1:49)
Nitric acid, conc.
Pyrrolidine
Chloroform
Carbon disulphide
Sodium hydroxide
Bromophenol blue
Lead nitrate

Detection range
1.0 to 10.0mg/l
ii) Atomic absorption
method (chelation
extraction)
Detection range
0.1 to 1.0 mg/l (with
graphite system
0.001 mg/l)

Atomic absorption spectrophotometer with air

acetylene flame
Hollow cathode lamp OR Electrode less Discharge
lamp for use at 283.3 nm
Separatory funnel
0.45m membrane filter
Acid washed filter paper
pH meter

102

iii) Differential pulse

anodic stripping
voltametry (DPASV)
Detection range
0.001 to 0.1mg/l

iv) Dithizone method

Detection limit
0.1 mg/l

Polarograph capable of performing differential

pulse work
Hanging mercury drop electrode
Platinum counter electrode
Saturated calomel reference electrode
Magnetic stirrer control unit with stirring bar
Scrubber assembly for nitrogen purification
Nitrogen gas (cylinder)
0.45m membrane filter

Lead nitrate
Hydrochloric acid, conc.
Nitric acid, conc.
Nitric acid, dil (1:1)
Granular zinc
Mercury
Ammonium metavandate

Spectrophotometer for use at 510 nm with 1-cm

cell
pH meter
TEF beakers, 100 ml
Separating funnels, 250 ml, 500 ml

Lead free distilled water

Lead nitrate
Nitric acid, 95% (w/w)
Nitric acid, dil 20% (w/w)
Nitric acid, dil (1:1)
Ammonium hydroxide Conc. (14 N)
Ammonium hydroxide, dil. 10% ( v/v)
Ammonium hydroxide, dil. 1% v/v)
Anhydrous Ammonium Citrate
Anhydrous Sodium Sulphite
Hydroxylamine hydrochloride
Potassium cyanide
Dithizone
Chloroform
Hydrochloric acid (1:1)

Atomic absorption spectrophotometer with

reducing Air acetylene flame
0.45m membrane filter
pH meter
Centrifuge

Deionised distilled water, Ammonia free

Nitric acid, redistilled 1:1 (v/v)
Hydrochloric acid, redistilled 1:1 (v/v)
Chromium oxide
Lanthanum chloride
Lanthanum oxide , 99.9%, w/w
Ammonium pyrrolidine dithocarbamate

CHROMIUM
6

5.2, Sl.
No. vi)
of
Table 3

Annex J of IS
13428:2005

103

7
NICKEL

5.2, Sl.
No. vii)
of
Table 3

Annex L of IS
13428:2005

Atomic absorption spectrophotometer with

nebulizer burner having air- acetylene flame
Centrifuge
Nickel hollow cathode lamp/electrode less
discharge lamp
Separating funnel, 250-ml with PTFE taps
pH meter

Nitric acid, conc. 1.4 g/ml

Pure nickel metal
Sodium hydroxide
Hydrochloric acid, conc. 1.19 g/ml
Methyl isobutyleketone (MIBK)
Ammonium 1 pyrrolidino
carbodithioate
Bromophenol blue
Ethanol

POLY
CHLORINATED
BIPHENYLE
(PCB)

5.2, Sl.
No.
viii) of
Table 3

Annex M of
IS 13428:2005

Gas chromatograph with EC detector & coupled

with printer-plotter-cum- integrator
Glass chromatographic column, 300 mm long, 8
mm ID with ground glass socket at the upper end
and a stop cock at low end.
Kuderna-Danish type, evaporator
Snyder columns
Syringe (5 l)
Heating oven
Desiccator

Silica gel, 60 100 mesh

N-hexane-redistilled
Potassium hydroxide pellets
Sodium hydroxide solution 5N
Diethyl ether, chromatography grade
Cotton wool, extracted with hexane and
diethyl ether
Acetic acid, glacial, redistilled
Chromium trioxide, re-crystallized
Apiezon L grease
Epikote Resin 1001 0.15 %
Chromosorb G (acid washed) DMCS
treated, 60 80 mesh
Silicone gum GE-S-SI 1.3 %

POLYNUCLEAR
AROMATIC
HYDROCARBON

5.2, Sl.
No. ix)
of
Table 3
APHA
6440

i) High Performance
Liquid
Chromatography
(HPLC) Method
ii) Gas
chromatographic
(GC) Method

High Performance Liquid Chromatograph

(HPLC) complete with gradient pumping system,
reverse phase column and detectors (UV and
fluorescence)

Gas Chromatograph (GC) complete with column

and flame ionization detector.
Separating funnel (2 l)
Evaporative flask
Three Ball Synder column
Kuderna- Danish Apparatus

Reagent Water
Sodium thiosulphate, granular
Cyclohexane
Methanol
Acetone,
Methylene chloride
Pentane Pesticide quality or
equivalent.
Acetonitrile HPLC quality
Sodium sulphate, granular, anhydrous
Silica Gel 100/200 mesh

104

Water bath (60-65C)

Stock standard solution

Std. PAHs Solutions
(a) 100 g/ml of naphthalene,
acenaphthylene, fluorine,
phneanthrene and anthracene.
(b) 5g/ml Benzo (k) fluoranthene

*Note: Besides listed Equipments/Apparatus/Chemicals, following accessories are essential part of a chemical lab:
i) General glass wares like Pipettes Burette, Conical flasks, Beakers, Measuring cylinders, Volumetric flasks, (of different volumes)
ii) Provision for distilled/double distilled water
iii) Fuming Hood and sink with tap in the lab
# The list does not cover the requirements of Pesticide Residues and Radio Active Residues as these requirements are got to be tested from outside approved
lab.

105

D - MICROBIOLOGICAL REQUIREMENTS

General microbiological lab equipments **

Hot air oven (capable of 180 C).
Autoclave (capable of 15 psi/ 121 C) of suitable size as per need.
Weighing Balance with least count 0.01 g (least count 0.001 g, if Tergitol-7 agar medium or Crystal violet neutral red bile lactose (VRBL) agar is being
prepared in house).
pH meter with least count 0.1 pH unit.
Laminar air flow chamber OR inoculation room/cabinet fitted with U.V. tube light.
Hot plate for media preparation.
Membrane filtration assembly (including sterilized membrane filters of 47 mm to 50 mm diameter with 0.45 m pore size, vacuum pump (for applying
vacuum of about 70 kPa) and forceps with rounded tips).
Inoculation loop/needle.
Bunsen burner with LPG cylinder.
Thermostatically controlled water bath.
Air conditioner (recommended)
Refrigerator
Colony counting equipment (recommended)
General glasswares including, petri dishes (made of glass or plastic), volumetric pipettes (of capacity 1 ml and 10 ml), flasks, test tubes, culture bottles,
funnels, glass rod, measuring cylinders.
Thermometer with least count 1 C
Filter Paper
Cotton

Sl
No.

Parameter

Clause
Ref.

Referred Method
of Test

Test Equipment/Apparatus **

Chemicals/Media/Reagents **

(1)

(2)

(3)

(4)

(5)

(6)

Escherichia
coli (or
thermotolerant
bacteria)

5.1.1 of IS
14543 :
2004

i) Reference
method

General microbiological lab equipments

(as listed above)

Distilled water
MacConkey broth medium (Peptone, Sodium
taurocholate or Bile salts, Sodium chloride, Lactose,
Neutral red, Ethanol)

IS 5887 (Part 1) :
6.1.1 of IS

Incubator capable of maintaining 37 C

106

13428 :
2005

1976

Incubator capable of maintaining 44 C

(for test for growth with acid and gas
production in MacConkey broth)

Glass tubes open at both ends (for

motility test)

Seitz filtration assembly (for sterilizing

solution of urea for preparing medium for
urease test)

Durhams fermentation tubes (for

carbohydrate fermentation test)

MacConkey agar medium (MacConkey Broth, Agar)

Eosin methylene blue lactose agar medium (Peptone,

Dipotassium hydrogen phosphate, Agar, Lactose, Eosin
Y, Methylene blue)

Tergitol-7 agar medium (Proteose peptone, Yeast

extract, Lactose, Agar, Tergitol-7, Bromothymol blue)

Nutrient broth (Peptone, Meat extract, Sodium

chloride)
@ Nutrient agar (Nutrient broth, Agar)

Microscope and Glass slides (for Gram

staining)

TSI medium for H2S test (Meat extract, Yeast

extract, Peptone, Glucose, Lactose, Sucrose, Ferrous
sulphate, Sodium chloride, Sodium thiosulphate, Agar,
Phenol red)

Medium for urease test (Peptone, Sodium chloride,

Agar, Potassium dihydrogen phosphate, Phenol red,
Glucose, Urea)

Protease species as control for urease test (optional)

Medium for indole production (Peptone, Sodium

chloride, Strain of bacterium known to produce indole)

Kovacs reagent (for indole test) (p-Dimethylaminobenzaldehyde, Amyl alcohol or Iso-amyl alcohol,

107

Concentrated hydrochloric acid)

Medium for methyl red and Voges-Proskauer tests

(Peptone, Dipotassium hydrogen phosphate, Glucose)

Methyl red, absolute ethanol (for methyl red test)

-naphthol, ethanol, potassium hydroxide (for VogesProskauer Reaction)

Simmons citrate agar (Sodium chloride,

Magnesium sulphate, Ammonium dihydrogen
phosphate, Dipotassium hydrogen phosphate, Sodium
citrate, Agar, Bromothymol blue)

Peptone water medium (for carbohydrate

fermentation test) (Peptone, Sodium chloride,
Andrades indicator, Sugar)

Andrades indicator (for Peptone water medium for

carbohydrate fermentation tests) (Sodium hydroxide,
Acid fuschin)

Gram stain (Methyl violet or Crystal violet, Iodine,

Potassium iodide; Neutral red, Acetic acid, Ethanol)

Lactose (for carbohydrate fermentation test)

108

ii) IS 15185 :
2002

General microbiological lab equipments

(as listed above)

a) Standard Test

Water bath and/or incubator

thermostatically controlled (36 2 C and
44.0 0.5 C

Distilled water

Lactose TTC agar with sodium heptadecylsulphate

(Lactose, Peptone, Yeast extract, Meat extract,
Bromothymol blue, Agar; 2,3,5 Triphenyltetrazolium
chloride (TTC), Sodium heptadecylsulphate (Tergitol7))

Membrane filter of 0.2 m pore size (for

sterilizing TTC solution during preparation Tryptone soy agar (TSA) (Tryptic digest of casein,
of Lactose TTC agar)
Soy peptone, Sodium chloride, Agar)

Tryptone broth (Tryptic digest of casein, Ltryptophan, Sodium chloride)

Oxidase reagent (Tetramethyl-p-phenylene diamine

hydrochloride)

b) Rapid test
(Optional)

General microbiological lab equipments

(as listed above)
Ultra violet lamp, wavelength 254 nm (low
pressure mercury lamp)

Filter pads, with a diameter of at least 47

mm.

Water bath and/or incubator

thermostatically controlled (36 2 C and
44.0 0.5 C

Kovacs Reagent (p-Dimethylaminobenzaldehyde,

Amyl or butyl alcohol , Concentrated hydrochloric
acid)
Distilled water

Tryptone soy agar (TSA) (Tryptic digest of casein,

Soy peptone, Sodium chloride, Agar)

Tryptone bile agar (TBA) (Tryptone, Bile salts,

Agar)

Indole reagent (p-Dimethylaminobenzaldehyde,

Concentrated hydrochloric acid)

109

Coliform
Bacteria

5.1.2 of IS
14543 :
2004
6.1.2 of IS
13428 :
2005

i) Reference
method
IS 5401 (Pt. 1) :
2012

General microbiological lab equipments

(as listed above)

Incubator capable of operating at 30 C

1 C or 37 C 1 C

Distilled water

Crystal violet neutral red bile lactose (VRBL) agar

(Enzymatic digest of animal tissues, Yeast extract,
Lactose, Sodium chloride, Bile salts, Neutral red,
Crystal violet, Agar)

Test tubes of dimensions approximately

16 mm x 160 mm

Brilliant green lactose bile broth (Enzymatic digest

of casein, Lactose, Dehydrated ox bile, Brilliant green)

Durham tubes of dimensions appropriate

for use with the test tubes

ii) IS 15185 :
2002

General microbiological lab equipments

(as listed above)

Standard Test

Water bath and/or incubator

thermostatically controlled (36 2 C and
44.0 0.5 C

Distilled water
Lactose TTC agar with sodium heptadecylsulphate
(Lactose, Peptone, Yeast extract, Meat extract,
Bromothymol blue, Agar; 2,3,5 Triphenyltetrazolium
chloride (TTC), Sodium heptadecylsulphate (Tergitol7))
Tryptone soy agar (TSA) (Tryptic digest of casein,
Soy peptone, Sodium chloride, Agar)

Membrane filter of 0.2 m pore size (for

sterilizing TTC solution during preparation Tryptone broth (Tryptic digest of casein, Lof Lactose TTC agar)
tryptophan, Sodium chloride)

Oxidase reagent (Tetramethyl-p-phenylene diamine

hydrochloride)

Kovacs Reagent (p-Dimethylaminobenzaldehyde,

Amyl or butyl alcohol , Concentrated hydrochloric
acid)

110

Rapid test
(Optional)

General microbiological lab equipments

(as listed above)

Ultra violet lamp, wavelength 254 nm (low

pressure mercury lamp)

Filter pads, with a diameter of at least 47

mm.

Sulphite
reducing
anaerobes

5.1.4 of IS
14543 :
2004

Annex C of IS
13428 : 2005

6.1.4 of IS
13428 :
2005

Water bath and/or incubator

thermostatically controlled (36 2 C and
44.0 0.5 C
General microbiological lab equipments
(as listed above)
Screw cap bottles or vials and stoppers of
boron silicate glass of capacities 200, 100
and 25 ml
Test tubes - 150 mm x 13 mm

Distilled water

Tryptone soy agar (TSA) (Tryptic digest of casein,

Soy peptone, Sodium chloride, Agar)

Tryptone bile agar (TBA) (Tryptone, Bile salts,

Agar)

Indole reagent (p-Dimethylaminobenzaldehyde,

Concentrated hydrochloric acid)

Distilled water

Differential reinforced clostridial medium (DRCM)

(Peptone tryptic digest of meat , Meat extract, Yeast
extract, Starch, Hydrated sodium acetate, Glucose, Lcysteine-hydrochloride, Sodium hydroxide)

Iron wire
Sodium sulphite
Incubator (37 C 1 C)
Iron (III) citrate

Pseudomonas
aeruginosa

5.1.5 of IS
14543 :
2004
6.1.5 of IS
13428 :
2005

Annex D of IS
13428 : 2005

Anaerobic jar assembly (recommended)

General microbiological lab equipments
(as listed above)

Screw capped bottles

Distilled water
Medium for determination of presumed Pseudomonas
aeruginosa (DL asparagine, L proline, Anhydrous
dipotassium hydrogen phosphate, Magnesium sulphate
heptahydrate, Anhydrous potassium sulphate, Ethanol)

Incubator (37 1 C)

Confirmatory medium (Milk agar medium) [Skim

111

milk powder, Bacteriological yeast extract, Peptone,

Sodium chloride, Agar hexadecyltrimethyl ammonium
bromide (centrimide)]

UV cabinet fitted with UV lamp emitting

light of wavelength 360 20 nm
@

Magnetic stirrer (recommended)

Cellulose acetate or nitrate membrane of

pore size 0.22 m (for alternate
sterilization of ethanol)

Aerobic
Microbial
Count

5.1.6 of IS
14543 :
2004

IS 5402 : 2012

This
requirement is
not applicable
for Packaged
Natural
Mineral Water
6

Yeast and
Mould

5.1.7 of IS
14543 :
2004
6.1.6 of IS
13428 :
2005

IS 5403 : 1999

Clause D-10 (NOTE) of IS 13428 : 2005 specifies

confirmation of non-pigmented strains as a further step, if
required. Annex 2D of IS 13428 : 2005 specifies
biochemical characteristics to be tested for this purpose.
No specific apparatus, media and reagents have been
specified for the same. It is specified that commercially
available identification kits may be used for this.

Incubator, capable of being maintained

at 42 0.5 C

General microbiological lab equipments

(as listed above)

Distilled water

Incubators 21 C 1 C and 37 C

Plate count agar (PCA) (Enzymatic digestion of

casein, Yeast extract, Glucose anhydrous, Agar)

Colony counting equipment

Overlay medium (if necessary) Agar

General microbiological lab equipments

(as listed above)

Incubator (25 1 C)

Distilled water

Yeast extract-dextrose-chloramphenicol-agar medium

(Yeast extract, Dextrose, Chloramphenicol or
Oxytetracycline hydrochloride, Agar)

112

** NOTES
Note 1 The list does not cover the following requirements, as these parameters are got to be tested from outside approved lab:

i) Faecal streptococci and Staphylococcus aureus.

ii) Salmonella and Shigella.
iii) Vibrio cholera and V. parahaemolyticus.

Note 2 General Microbiological Lab Equipments as listed are common for various microbiological tests. Other additional equipments required for specific test
methods are indicated against each parameter.

Note 3 For preparation of culture media and reagents ingredients of uniform quality and chemicals of analytical reagent grade should be used. Alternatively,
commercially available media and reagents may be used provided their composition comply with those given in Indian Standards.

Note 4 Disposable glassware may be accepted as an alternative to re-usable glassware.

Note 5 All efforts have been made to compile the list as per the respective standards exhaustively covering all the required test equipments, apparatus and
chemicals. However, in case any omission or incorrectness is noticed while referring, the same may be conveyed to CMD immediately for suitable actions.

The marked equipments/ chemicals and media are required for confirmatory tests of respective microorganisms. The confirmatory test may be dispensed
with/omitted, provided the licensee undertakes to start corrective actions based on presumptive presence of microorganisms.

113

E - REQUIREMENTS FOR BOTTLES/CONTAINERS FOR PACKAGED WATER

Sl.
No.

Clause No. Specified

of IS
Requirement
15410:2003
4.1
Material

Test Facility
Requirement
---

Range and Accuracy/

Least Count ( If and
as Applicable)
----

Visual

-----

4.2
4.2.1
4.3

4.3.1
4.3.2
4.4

Design, Shape
and Dimensions
Manufacture,
Workmanship,
Finish and
Appearance
Capacity

Visual
Weighing Balance

4.5

Wall Thickness

or
Measuring Cylinder
Micrometer

4.6.2

Transparency

Transparency/ Haze Meter

4.6.3

Leakage Test

8
9

4.6.4
4.6.5

Drop Test
Migration Test

10

4.6.6

Water Potability
Test

Vibration Leakage Tester as per Cl. 6.2.1 of

IS 2798
Reservoir
Air Pressure Leakage Tester
Drop Tester with height of 0.5 m
Oven/Water Bath
Hot Plate
Analytical Balance
SS Evaporating Dish
Dessicator
Glass Beaker, pyrex, 1000 ml
Pouch Sealing Machine
Conditioning Chamber

--------Suitable range with ,

LC 0.1 g for Balance
or
1 ml for Cylinder
Suitable Range with
LC 0.02 mm
Range upto 100 %,
LC 1%
-

Capable of
maintaining
40+2 C

Method of Test/
Remarks (If any)
Raw Material
conformity to ISs is
indicated

To adhere GMP
-Cl 5 of IS 2798

Cl 4.5 of IS 2798
Annex A of
IS 15410
Cl 6 of IS 2798

Cl 8 of IS 2798
IS 9845

Capable of
Annex B of
maintaining 38+2 C IS 15410

114

F- REQUIREMENTS FOR POLYETHYLENE FLEXIBLE POUCHES FOR PACKAGED WATER

Sl.
No.

Clause
No.

Specified
Requirement

Clause 6.1 Requirements for Films

1
6.1.1
Description
2
6.1.2
Film Form
3
6.1.3
Winding of Film
4
6.1.4
Odour
5
6.1.5
Thickness
(65 5/ 75 5)
6
6.1.6
Width (in mm)
7

6.1.7

Overall Migration

6.1.8

Tensile Strength

9.

6.1.9

Elongation at
break

10.

6.1.10

Dart Impact
Resistance

Test Facility
Requirement

Range and Accuracy/

Least Count ( If and
as Applicable)

Visual
Visual
Visual
Olfactory
Dead Weight Dial
Micrometer
Scale

----------------------------------------------------------------Suitable Range with

LC 1
Suitable Range,
LC 1 mm
Capable of
maintaining 40 + 2o C

Oven/Water Bath
Hot Plate
Analytical Balance
SS Evaporating Dish
Dessicator
Glass Beaker, pyrex, 1000 ml
Pouch Sealing Machine
Tensile Testing Machine of
suitable range

Method of Test/ Remarks (If any)

A-2 of IS 2508

IS 9845

LC 0.01 kN

A-4 of IS 9845

Tensile Testing Machine of

suitable range

LC 0.01 kN

A-4 of IS 9845

Dart Impact Tester with Drop

Height of 66 cm

Set of weights
(Min. Impact failure
load : 2.20 N)

A-6 of IS 9845

Table conforming to
IS 7028 (Pt 2)

Annex D of
IS 15609

Clause 7 Requirements for Pouches

11. 7.1
Vibration
Vibration Table
Leakage Test
Temp. - Ambient or

115

27 + 20 C in
case of dispute
Oven/Heating Arrangement

12.

7.2

Water Potability
Test

13.

7.3

Stack Load Test

14.

7.4

Drop Test

15.

7.5

Ink Adhesion Test Pressure Sensitive Tapes or

for Printed Pouch Cello- Tape

Pouch Sealing Machine

Flat Wooden Plank
Temp. - Ambient or
27 + 20 C in
case of dispute
Arrangement for flat drop
from 1.2 m height

Frequency of
vibration 2 Hz
Capable of
maintaining 38 + 2o C

Annex E of
IS 15609

Set of weights for

20 N to 200 N

Annex F of
IS 15609

-----------

Annex G of
IS 15609

25 mm wide tape

Annex H of
IS 15609

Arrangement for
pulling tape at 10
mm/s at about 90 o
16.

7.6

Product
Resistance Test
for Printed Pouch

Clause 8 Construction
17. 8
Construction

Paper Tissue

--------------

Visual

-----------------

Annex J of
IS 15609

116

Amendment No.1 to PDW Manual Doc No.SM/IS 14543 & IS 13428/03, JULY 2013
Clause 4.10 - add the following text after Note 1

Note 2 - There may be cases when the sample of container drawn during the preliminary
inspection or verification visit (under simplified procedure), before GOL, is found to be
failing in ONLY the requirements of:
a)

wall thickness which is evaluated against a declared value

requirement of drop test); or/and

b)

brimful capacity .

(but passing in the

As these requirements do not have a bearing on the quality of the container and/or the product
for considering GOL, the applicant shall be advised to submit corrective actions and offer
improved sample of container for independent testing.
In such cases, if the applicant establishes through documentary evidence that the
improved container samples are procured from the same supplier and are made from
the same source and type of raw material as the container sample earlier offered for
independent testing during the preliminary/verification visit and submits the supplier's
certificate of conformity to IS 15410, then GOL may be considered based on the conformity
of the improved container to the requirements of wall thickness and/or brimful capacity, as
the case may be, through independent testing.

Amendment No.1 to PDW Manual Doc No.SM/IS 14543 & IS 13428/03, JULY 2013
Clause 4.10 - add the following text after Note 1

Note 2 - There may be cases when the sample of container drawn during the preliminary
inspection or verification visit (under simplified procedure), before GOL, is found to be
failing in ONLY the requirements of:
a)

wall thickness which is evaluated against a declared value

requirement of drop test); or/and

b)

brimful capacity .

(but passing in the

As these requirements do not have a bearing on the quality of the container and/or the product
for considering GOL, the applicant shall be advised to submit corrective actions and offer
improved sample of container for independent testing.
In such cases, if the applicant establishes through documentary evidence that the improved
container samples are procured from the same supplier and are made from the same source and
type of raw material as the container sample earlier offered for independent testing during the
preliminary/verification visit and submits the supplier's certificate of conformity to IS 15410, then
GOL may be considered based on the conformity of the improved container to the requirements of
wall thickness and/or brimful capacity, as the case may be, through independent testing.