Technical Particulars For Sanitary Napkins

For RC Period (01-10-2015 To 30-09-2016)

Generated on: November 15, 2017 2:50 AM NIC

Schedule 1 Sanitary Napkin

Unit : Packet

Size Pad Type Weight (in gm + -1)

1 Regular With Tabs 8

2 Regular Tabless 8
3 Large With Tabs 9
4 Large Tabless 9
5 Extra Large With Tabs 10
6 Extra Large Tabless 10

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 Detailed Specification

Schedule 1 Sanitary Napkin

Specification :

Sanitary Napkin confirming to IS: 5405/1980 (First Revision) reaffirmed

2012 with amendement No.1 except sizes and as per General Technical Requirement. A
Packet contains 6 Nos. of Sanitary Napkins.

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Drawing/Proforma/Annexure Attached [Click on following to view/print]

INSPECTION REPORT PERFORMA

General Technical requirement For TE :

A. Technical Requirements for Sanitary Napkins:

1. Sanitary Napkin shall confirm to IS:5405/1980 (First Revision) reaffirmed 2012

with amendement No.1 except Sizes.
The Size and weight of Sanitary napkin shall be as under:

Size Pad Type Overall Pad Pad Width(mm) Weight(gm)

Length (mm) Thickness
(mm)
Regular Napkin with Tabs 200+-10 10+-1.5 160+-5 8+-1
Large Napkin with Tabs 240+-10 10+-1.5 160+-5 9+-1
Extra Large Napkin with Tabs 280+-10 10+-1.5 160+-5 10+-1
Regular Tabless Napkin 200+-10 10+-1.5 75+-5 8+-1
Large Tabless Napkin 240+-10 10+-1.5 75+-5 9+-1
Extra Large Tabless Napkin 280+-10 10+-1.5 75+-5 10+-1

2. Storage of the raw materials and the finished product in clean place protected from
moisture, dust and rodents. This has to follow by supplier/ consignee essentially.
3. The sanitary napkins should be odorless.
4. The material used in the fabrication of the sanitary napkins should be non
allergic.
5. Outer covering of sanitary napkin shall be provided with sufficient number of
channels for showing up protection.
6. Covering of the absorbent filler should be non-allergic and shall be constructed
with either qualitative poly-perforated film sleeve or Non-woven fabric with
sufficient porosity to enable assembled pad to meet the absorbency requirement and
the absorbent filler material shall be of cellulose pulp/ wadding and shall be free
from lumps, oil spots, dirt and foreign materials.
7. The Absorbent filler material pertains to sanitary napkin shall be associated with
an adhesive back strip.
8. Back strip for sticking the sanitary napkin shall be with qualitative adhesive
material not leaving any mark.
9. The Sanitary Napkin should be heat sterilizable and the non absorbent barrier
should be heat resistance.
10. Absorbency test will be conducted with 50 ml prescribed fluid instead of 30 ml of
cl 5.1 of IS:5405/1980 (First Revision) reaffirmed 2012 with amendement No.1
11. Napkin shall have a non-absorbent barrier on one side which shall have an
identifying thread or marking indicating clearly the side of barrier.
12. The manufacture shall get the sanitary napkins tested as per IS:5405/1980 (First
Revision) reaffirmed 2012 with amendement No.1, and as per clause mentioned in
Technical Requirements for Sanitary Napkins in General Technical Requirements from
NABL/ILAC accredited/Central Govt. laboratory at the time of inspection/ registration.

13. Sampling of Store :

Random Sampling Plan for the pre-dispatch inspection by the Inspecting Authority is
as under :

Quantity offered Samples drawn for Sub Samples for absorbency & pH value
(in Nos) physical parameters test (in Nos )
(in Nos)
Below 1000 10 1

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1000 to 10,000 30 3
10,001 to 30,000 50 5
30,001 to 50,000 70 7
50,001 to 70,000 80 8
70,001 t0 1,00,000 90 9

If the batch size exceeds 1,00,000 nos. the same shall be distributed in separate lots
and samples to be drawn using above said sampling plan. All the samples shall meet the
requirements.

14. The sanitary napkin must have minimum shelf life of three Years from the date of
manufacture and at least 5/6 of the shelf life should be available at the time of
shipment/ inspection based on the declaration of the firm.

15. Packaging and Labeling:

(i) Primary Packaging:
Primary package shall contain six sanitary napkins in a polythene bag
of qualitative material with GSM 35-40 and make sure that the pack does not tear in
routine handling. The same shall conform to size of product with proper sealed. The
designing and printing on the primary packs shall be done by the manufacturer/Supplier
as per printing matter including logo in four colours using weather proof ink
intimated by the users. The printing shall not wipe of and remain intact during use.
Name, manufacturing license number, address of manufacturer and length, dimensions,
Lot/batch no. date, month and year of manufacture and date, month and year of expiry,
Nos. of napkins with appropriate advice for storage shall be shown in each package.
The designing of primary package shall be subject to the approval of purchaser.

(ii) Secondary Packaging :

Secondary package should be packed primary packing in the boxes made of
corrugated paper sheet contain 5 X 120 GSM or effective 720 GSM for easy handling,
transport and distribution and to avoid tear. Each box shall be able to keep 160
primary packages. The packing material of the secondary packing shall have minimum
bursting strength of 9-10 Kg/Cm2. Designing and Printing shall be made as provided by
the user or according to primary package. On the exterior of secondary package,
following information either shall be stenciled or labelled in bold letters in at
least aerial front size 14 with water proof ineligible ink in a legible manner.

(i) Generic name of product

(ii) Lot/ Batch no.
(iii) Date, month & year of manufacture
(iv) Expiration Date, month & year or Best before
(v) Manufacturer's name and registered address
(vi) Consignee Address
(vi) Number of boxes contained in a carton
(vii) Gross weight of each carton (in Kg)
(viii) Instructions for storage and handling
(ix) Disposal instructions such as napkin without covering can be disposed of in
water closets.
(x) Method of use.
(xi) Indication as to which side is absorbent.

16. Inspection of store will report in Inspection Report Performa DQA/GE/RC-292.

17. A Packet contains 6 Nos. of Sanitary Napkins.

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TP Prepared By TP Scrutenised By

Name K.K.Nagpal S.K.RASTOGI

Desig AD(QA) DEPUTY DIRECTOR (QA)
Date 17-07-2015 17-07-2015
TP Approved By
TP Recommended By

Name A.K.Jain
Desig Director(QA) DDG(QA)
Date 17-07-2015 24-07-2015

Forwarded to(Purchase Dte.): Medical Stores

With Ref. To(Pur. Wing No.): MS/6/2015 MS/Part dated 29.5.2015

DQA/GE/RC-292
QA Wing Ref. No.

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