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Packaging Validation of Paracetamol Tablets BP 500 mg

Article  in  International Journal of Research in Pharmaceutical and Biomedical Sciences · September 2013

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 International Journal of Research in Pharmaceutical and Biomedical Sciences ISSN: 2229-3701

_________________________________________Research Article

Packaging Validation of Paracetamol Tablets BP 500 mg

D. Narayana Murthy1*, K. Chitra1, J. Beena2 and G. Jagadheesan2
1Sri Ramachandra College of Pharmacy, Sri Ramachandra University, Chennai – 600116,
Tamil Nadu, India.
2Fourrts (India) Laboratories, Pvt, Ltd, Plant-II, Venkatamangalam, Kandigai
Chennai – 600 0 48, Tamil Nadu, India.

ABSTRACT
Validation is documented evidence which provide high degree of assurance that specific process will
consistently produce product with predetermined specification and quality attributes. And it is considered as
key requirement of all GMP guidelines as it enables consistent manufacturing and packaging of products in
accordance with the product quality and market requirements in a cost effective and secure manner.
Packaging is defined according to WHO as a process that bulk material must undergo finished product. The
basic need for packaging validation is that it enables packaging process to meet the product and market
requirements i.e. quality attributes and consumer needs in a cost effective and consistency efficient process
with minimum down time, rejects and errors. For this purpose, the validation study for packaging process was
carried out for forming temperature & sealing temperature optimization, speed optimization, efficiency of
tablet feeder, Blister inspection system, print registration control, function of base and lidding foil end sensor,
splice detector efficiency, shrink wrapping and impact assessment of de-blistered tablets. And this article
clearly emphasizes different types of test involved in packaging validation, importance of packaging validation
and key activities to achieve it successfully.

Keywords: Validation, packaging, Blister inspection system, Print registration control.

INTRODUCTION and /or maintenance without affecting the product

Packaging is the art of science and technology of
preparing products for sale in a cost effective
manner.1,2 With respect to pharmaceuticals,
packaging is a key component of the product and
must preserve the product from environmental
degradation or contamination, contain the product
securely in order to avoid leakage, identify the
product from its pack and thereby provide
traceability, provide security against tampering and
counterfeiting of the product, provide to the patient
the information on use for compliance, provide
convenience in use of the product for medical staff
or patient. All these things must be ensured for the
life of the product and achieved within a complex
regulatory environment. To carry out a meaningful
packaging validation following are key areas which
have impact on the robustness of a packaging
process.
a. Packaging line layout
This will have a major impact on the efficiency of
the packaging line. And this layout should include
the ability to manage quick change over, perform
line clearance between batches of product and
clean the line in an easy and controlled manner.
The layout should provide easy access for operators
and the engineers for various machine adjustments
on or near the machine. In this first step of the
validation includes identification of topology of the
system, and next is to identify and list the system
functionality i.e. the software and hardware of the
system to be tested and verified as being in
working order to enable validation to be performed.
b. Well designed equipment will lend itself to
efficient production of a consistent standard
product. Where as incase of older equipment, it is
often considered that they can be inflexible and
have elements of poor design such as areas where
packaging components or product may be trapped,
resulting in product being incorrectly packed. This
represents an ultimate risk to the patient and it is
one of major reason for product recall in the
industry.
c. Assess the GMP risk
Although all GMP risks are important one can
specifically take into consideration product defect
class 1 (critical) defect /intolerable defect
(dangerous and pose serious health hazard) leading
to product recall.
e.g. the contents of the package do not match the
labeling on the package, printing errors on labels

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 International Journal of Research in Pharmaceutical and Biomedical Sciences ISSN: 2229-3701

and package inserts, incorrect packaging Table 1: list of equipment used in packaging
component in the final assembly. Equipment
Qualification
status
Check weigher Qualified
d. Standard Operating Procedure Blister packaging
It is one of important aspect of packaging Qualified
machine
validation exercise. SOP should be clear and it Inkjet printer Qualified
should contain instructions on how to operate, De-blistering machine Qualified
adjust, and maintain each piece of equipment. In Weighing balance Qualified
Shrink wrap machine Qualified
addition to that there should be a procedure in
detail how a batch has to be packaged. Besides that
SOP should explain how each material is received
Table 2: List of materials used in packaging
in to the line and checked for correctness, quantity
by the operators. S.NO. Item Characteristic
01 Shipper 7ply corrugated
02 leaflet For patient guidance
e. Packaging testing program 03 PVC film clear PVC film clear 142 mm
It basically involve all written specification for Printed blister Printed blister aluminium
04
packaging materials and the product package and Aluminium foil foil 142 mm
include the nature, extent and frequency of routine
test such as: PROCEDURE
a. Visual inspection, test to identify the materials, Paracetamol tablets were manufactured are packed
dimensional tests, physical, chemical and in blister packages. Three batches of the tablets,
microbiological test. each of batch size 5, 50,000 tablets are taken into
consideration. The entire process is divided into
f. Training various stages.
It is one of most important element in any
validation activity. Training of operators and Blister packing
engineers on a packaging line is integral to After line clearance issued from QA personnel the
equipment installation and qualification. Records materials which were required for packaging
of relevant training and experience should be operation is brought to the primary packaging area
maintained and be available. and then to secondary packing area. After careful
setting of printed blister aluminium foil and PVC
g. Qualification protocols film clear foil to the machine. The machine was
It is one of basic approach to any validation is that switched on and checked for following parameters
to prepare test protocols for design qualification,
installation qualification, operational qualification 1. Forming temperature optimization
and performance qualification. Information Forming temperature optimization was
gathered from the each stage is fed into the next to carried out for all validation batches
ensure that the system is adequately tested. during this operation forming temperature
was setted at different temperature i.e. 110
o
h. Performance qualification (PQ) C, 120 oC, 130 oC, 140 oC and observed
It is last but most important stage in equipment for blister quality. Based on the result
validation and it should reflect real production minimum forming temperature &
environment. It is an area where one needs to pay maximum forming temperature was
lot of attention as depending upon the line determined. At the established optimum
topography. forming temperature range the speed of
It requires to test each piece of equipment in the machine kept at 15, 20, 25, 30 PPM and
line and to test the interaction between different observed for blister quality.
pieces of equipment/ system, ensure that the
validation activity is designed to test all the critical 2. Sealing temperature optimization
steps, provide a list of test which are to be Taking the optimum forming temperature
performed and acceptance limits for each test.3 established, sealing temperature
verification was done. It is carried out for
MATERIALS AND METHODS all validation batches during this operation
In this study Paracetamol tablets manufactured are sealing temperature was set at different
packed in blister packages. Three batches of the temperature i.e. 180 oC, 190 oC, 195 oC,
tablets each of batch size 5, 50,000 tablets are taken 200 oC, 210 oC and observed for blister
into consideration. The list of equipments and quality. Based on the result optimum
materials used for primary and secondary sealing range is established i.e. minimum
packaging validation studies are mentioned in sealing temperature & maximum sealing
Table 01 and 02. temperature. At the established optimum

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International Journal of Research in Pharmaceutical and Biomedical Sciences
sealing temperature range the speed of the
machine kept at 15, 20, 25, 30 PPM and
observed for blister quality.
3. Speed optimization
At the established optimum forming
temperature range run the machine at
different speed 15, 20, 25, 30 PPM and
verify the blister quality. And conduct
leak test for 09 blisters (03 blisters per
cut). Based on the result optimum speed
range is established i.e. minimum speed
and maximum speed.
At the established optimum sealing
temperature range run the machine at
different speed 15, 20, 25, 30 PPM and
verify the blister quality. And conduct
leak test for 09 blisters (03 blisters per
cut). Based on the result optimum speed
range is established i.e. minimum speed
and maximum speed.
4. Verification of optimum forming
temperature and optimum speed range
At the established maximum forming
temperature and minimum established
machine speed blister were checked for its
quality and leak test is performed for 09
blisters (03 blisters per cut). And at the
established minimum forming temperature
and maximum established machine speed
blister were checked for its quality and
leak test is performed for 09 blisters (03
blisters per cut).
5. Verification of optimum sealing
temperature and optimum speed range
At the established maximum sealing
temperature and minimum established
machine speed blisters were checked for
its quality and leak test is performed for
09 blisters (03 blisters per cut). And at the
established minimum sealing temperature
and maximum established machine speed
blister were checked for its quality and
leak test is performed for 09 blisters (03
blisters per cut). Based on the result
optimum speed with optimum sealing
temperature is established.
6. Efficiency of tablet feeder
It is carried out for all validation batches
during this operation flow of tablets from
hopper – chute – brush box to forming
plate was observed and checked for the
presence of chipping, breaking and
jamming of tablet and effectiveness of
feeder level sensor.
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7. Blister Inspection System efficiency
(BIS)
It is checked for following parameter.
a) Non filled blister detector
accuracy
In this one or more tablets were
removed from the blister cavity
and passed through BIS camera.
Blister without any tablet was
detected and rejected.
b) Black spot detector efficiency
In this one of the tablet is
marked with black spot with
black marker manually. And
mark the blister with marker and
place the tablet in the blister
cavity and pass through BIS
camera. Blister with black spot
was detected and rejected.
c) Shaped tablet detector
accuracy
In this different shape tablet was
placed in blister cavity instead of
circular shape. Blister with
different shape tablet was
detected and rejected.
d) Foreign particle detector
accuracy
In this operation along with the
tablet in the blister cavity foil
pieces are kept in the blister
cavity and passed through the
BIS camera. Blister with foreign
particles (Foil pieces) was
detected and rejected.
8. Print registration control: PRC value is
set as per respective BPR. All the printed
lidding foil in between two eye marks and
join the foil with the help of cellophane
tape and pass through the PRC sensor. If
PRC value mismatched with the set value
it should be detected by the PRC sensor
and machine should stop.
9. Splice detector
In this case if no splice is present in any of
the base/lidding foil, insert one splice in
either of base/lidding foil by cutting the
foil and joining the foil with the help of
cellophane tape and pass through the
splice detector. It is carried out for all
validation batches and the presence of
splice foil in the blister was detected by
the detector and the same blister was
rejected.
10. Function of base and lidding foil
Without base and lidding foil the machine
should not start.
952
 International Journal of Research in Pharmaceutical and Biomedical Sciences ISSN: 2229-3701

11. Carton with missed leaflet and carton with
additional leaflet was detected by check
weigher and same carton was detected and
rejected. And set compressed air pressure
at 3, 4, 5, 6 and 7 Kg /cm2 and verify for
rejection in case of missing leaflet.
12. Shrink wrapping
The machine was set with the temperature
as mentioned in the respective BPR and
carton with shrink film was passed
through the conveyor. And samples were
collected for finished product testing.
13. Impact assessment
After completion of first run packaging
blister to be de-blistered are de-blistered
by de-blistered machine and tablets were
collected and inspected. And the de-
blistering process is done for 2nd run and
3rd run. And only 3rd run samples were
sent QC for description, Identification by
IR, hardness, thickness, friability,
dissolution & assay. At the end of
operation switch off the main, wait for 3
minutes and again switch on the main and
start the packaging, observe for physical
parameters and perform the leak test for
09 blisters. After completion of shrink
packaging pass 01 shrink bundle 03 times
each through the shrink packaging
machine and collect 01 shrink box and
send to QC for description, identification
by (IR), hardness, disintegration test,
friability, dissolution, related substances
and assay.

RESULTS

Table 3: Results for forming & sealing temperature optimization

RESULTS OF FORMING TEMPERATURE OPTIMIZATION
Batch-I
Machine speed: 20 PPM ( Speed Constant)
Measured Observation
S.NO Acceptance criteria
parameter 110 º C 120 º C 130 º C 140 º C
Physical appearance of the
forming should be proper
Cutting should be uniform on
all sided without any angular
cuts
Over printing should be
visible and readable
01 Blister quality Complies Complies Complies Complies
Proper knurling should be
observed
No pinholes should be when
observed against fluorescent
light
All 09 blister to comply to
leak test
All 09 blister packs should
02 Leak test Pass Pass Pass Pass
pass the leak test
RESULTS OF SEALING TEMPERATURE OPTIMIZATION
Batch-I
Machine speed: 20 PPM (Speed Constant)
Measured Observation
S.NO Acceptance criteria
parameter 180 º C 190 º C 195 º C 200 º C 210 º C
Cutting should be uniform on
all sided without any angular
cuts
Over printing should be visible
and readable
Proper knurling should be
0 Blister quality Complies Complies Complies Complies Complies
observed
No pinholes should be when
observed against fluorescent
light
All 09 blister to comply to leak
test
All 09 blister packs should pass
02 Leak test Pass Pass Pass Pass Pass
the leak test

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 International Journal of Research in Pharmaceutical and Biomedical Sciences ISSN: 2229-3701

Table 4: Results of speed optimization

RESULTS OF SPEED OPTIMIZATION
Batch-I
Minimum forming temperature set: 120º C
Measured Observation
S.NO Acceptance criteria
parameters 15 20 25 30
Forming cavity should be proper
Physical appearance of forming cavity
should be proper
Cutting should be uniform on all sided
01 Blister quality without any angular cuts Complies Complies Complies Complies
Embossing should be visible and readable
and knurling should be proper
No pinholes should be when observed
against fluorescent light
02 Leak test All 09 blister packs should pass the leak test Pass Pass Pass Pass
Maximum forming temperature: 140º C
Measured observation
S.NO Acceptance criteria
parameters 15 20 25 30
Forming cavity should be proper All other
All other
Physical appearance of forming cavity parameter was
parameter was
should be proper found to comply
found to comply
Cutting should be uniform on all sided with the
with the
01 Blister quality without any angular cuts Complies Complies acceptance
acceptance
Embossing should be visible and readable criteria.
criteria.
and knurling should be proper Improper
Improper cutting
No pinholes should be when observed cutting was
was observed
against fluorescent light observed
02 Leak test All 09 blister packs should pass the leak test Pass Pass Pass Pass

Table 5: Results of speed optimization

RESULTS OF SPEED OPTIMIZATION
Batch-I
Minimum sealing temperature set: 180º C
Measured Observation
S.NO Acceptance criteria
parameters 15 20 25 30
All other All other
Cutting should be uniform on all sided
parameter was parameter was
without any angular cuts
found to comply found to comply
Embossing should be visible and readable
01 Blister quality Complies Complies with the with the
and knurling should be proper
acceptance criteria acceptance criteria
No pinholes should be when observed
Improper cutting Improper cutting
against fluorescent light
was observed was observed
02 Leak test All 09 blister packs should pass the leak test Pass Pass Pass Pass
Maximum sealing temperature: 210º C
Measured observation
S.NO Acceptance criteria
parameters 15 20 25 30
All other All other
Cutting should be uniform on all sided parameter was parameter was
without any angular cuts found to comply found to comply
Embossing should be visible and readable with the with the
01 Blister quality Complies Complies
and knurling should be proper acceptance acceptance
No pinholes should be when observed criteria. criteria.
against fluorescent light Improper cutting Improper cutting
was observed was observed
02 Leak test All 09 blister packs should pass the leak test Pass Pass - -

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International Journal of Research in Pharmaceutical and Biomedical Sciences ISSN: 2229-3701

Table 6: Results of Minimum speed & Maximum forming temperature, Maximum speed
& Maximum forming temperature
Batch-I
Minimum speed: 15 PPM
Maximum forming temperature: 140º C
Measured
S.NO Acceptance criteria Observation
parameter
Physical appearance of forming
cavity should be proper
Physical appearance and forming cavity was proper.
Cutting should be uniform on all
Cutting was uniform on all sides with out any angular
sided without any angular cuts
cuts.
01 Blister quality Embossing should be visible and
Embossing was visible and readable.
readable and knurling should be
Proper knurling was observed.
proper
No pinholes was observed against fluorescent light
No pinholes should be when
observed against fluorescent light
All 09 blister packs should pass the
02 Leak test Pass
leak test
Maximum speed: 20 PPM
Minimum forming temperature: 120º C
Measured
S.NO Acceptance criteria Observation
parameter
Physical appearance of forming
cavity should be proper
Physical appearance and forming cavity was proper.
Cutting should be uniform on all
Cutting was uniform on all sides with out any angular
sided without any angular cuts
cuts.
01 Blister quality Embossing should be visible and
Embossing was visible and readable.
readable and knurling should be
Proper knurling was observed.
proper
No pinholes was observed against fluorescent light
No pinholes should be when
observed against fluorescent light
All 09 blister packs should pass the
02 Leak test Pass
leak test

Table 7: Results of minimum speed & maximum sealing temperature, Maximum speed
& Minimum sealing temperature
Batch-I
Minimum speed: 15 PPM
Maximum sealing temperature: 210º C
Measured
S.NO Acceptance criteria Observation
parameter
Cutting should be uniform on all
sided without any angular cuts Cutting was uniform on all sides with out any angular
Embossing should be visible and cuts.
01 Blister quality readable and knurling should be Embossing was visible and readable.
proper Proper knurling was observed.
No pinholes should be when No pinholes was observed against fluorescent light
observed against fluorescent light
All 09 blister packs should pass the
02 Leak test Pass
leak test
Maximum speed: 20 PPM
Minimum sealing temperature: 180º C
Measured
S.NO Acceptance criteria Observation
parameter
Cutting should be uniform on all
sided without any angular cuts Cutting was uniform on all sides with out any angular
Embossing should be visible and cuts.
01 Blister quality readable and knurling should be Embossing was visible and readable.
proper Proper knurling was observed.
No pinholes should be when No pinholes was observed against fluorescent light
observed against fluorescent light
All 09 blister packs should pass the
02 Leak test Pass
leak test

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 International Journal of Research in Pharmaceutical and Biomedical Sciences ISSN: 2229-3701

Table 8: Results of optimum speed & optimum temperature

Observation
Measured
S.NO Acceptance criteria Optimum temperature: 195º C
parameter
Optimum speed set : 18 PPM
Cutting should be uniform on
all sided without any angular
cuts Batch-I Batch-II Batch-III
Embossing should be visible
01 Blister quality and readable and knurling
should be proper
No pinholes should be when
observed against fluorescent Complies Complies Complies
light
All the 09 blister packs
02 Leak test Pass Pass Pass
should pass the leak test

Table 9: Results of verification of tablet feeder efficiency at blister packaging stage

S.NO Test Acceptance criteria Observation
Flow of tablets from Batch-I Batch-II Batch-III
Proper flow of tablets should be
hopper through
01 observed and all formed pockets Complies
chute brush box to Complies Complies
should be filled.
forming plate
Chipping, breaking Tablet feeding should be smooth
02 and jamming of without chipping braking & jamming Complies Complies Complies
tablets of tablets
When the tablets reaches below the
minimum feeder level the vibrator
Effective of feeder
03 should switched on automatically and Complies Complies Complies
level sensor
the tablets should be filled in the
feeder

Table 10: Results of verification blister inspection system

S.NO Test Acceptance criteria Observation
Non-filled Blister with non-filled pack should be Batch-I Batch-II Batch-III
01
detector detected & rejected Complies Complies Complies
Black spot Blister with black spotted tablet should be
02 Complies Complies Complies
detector detected and rejected
Shaped tablet Blister with different shape tablet should be
03 Complies Complies Complies
detector detected and rejected
Foreign
Blister(Tablet with foreign particle should
04 particle Complies Complies Complies
be detected and rejected)
detector

Table 11: Results for print registration control/splice/foil end sensor

S.NO Test Acceptance criteria Observation
when the PRC value mismatched with set Batch-I Batch-II Batch-III
PRC sensor
01 value it should be detected by the PRC
verification Complies Complies Complies
sensor& the machine should stop
The splice detector should detect the spliced
Splice detector
02 foil ( joint in between the foil) and the same Complies Complies Complies
efficiency
blister should be rejected by the machine
Base
foil/lidding With out base foil & lidding foil sensor
03 Complies Complies Complies
foil sensor should be detected and machine should stop
verification

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 International Journal of Research in Pharmaceutical and Biomedical Sciences ISSN: 2229-3701

Table 12: Results of verification of sensor in check weigher

S.NO Test Acceptance criteria Observation
Carton with missed leaflet should Batch-I Batch-II Batch-III
Verification of missing be rejected & rejected carton
01
leaflet in marked carton should be dropped in the rejection Complies Complies Complies
box
Verification of Carton with additional leaflet
02 additional leaflet in should be rejected & carton should Complies Complies Complies
marked carton be dropped in the rejection box
Complies for 4 to Complies for 4 to 7
Carton should be rejected and Complies for 4 to 7
Compressed air pressure 7 Kg/cm2. Not Kg/cm2. Not
03 rejected carton should be dropped Kg/cm2. Not complies for
verification complies for complies for 3.0 2
in the rejection box 3.0 Kg/cm
3.0 Kg/cm2 Kg/cm2

Table 13: Results of de-blistered tablets 3rd run

Observation
S.NO Test
Batch-I Batch-II Batch-III
White, flat, circular
White, flat, circular uncoated White, flat, circular uncoated
uncoated tablet with
tablet with “PARA/500” tablet with “PARA/500”
01 Description “PARA/500” debossed on
debossed on one side and plain debossed on one side and plain on
one side and plain on other
on other side other side
side
Identification
02 Complies Complies Complies
By IR
03 Average weight 564.4mg 567.2mg 567.9 mg
Avg: 564.4mg Avg: 567.2mg Avg: 567.9 mg
Uniformity of
04 Min: 560.2mg Min: 560.1mg Min: 560.7 mg
weight
Max: 574.6mg Max: 575.5mg Max: 576.1 mg
Avg: 177.5N Avg: 241.5N Avg: 217.4N
05 Hardness Min: 149.6N Min: 208.5N Min: 180.6N
Max: 223.4N Max: 287.0N Max: 24.9N
Avg: 3.92mm Avg: 3.85mm
Max: 3.88mm
06 Thickness Min: 3.84mm Min: 3.83mm
Min: 3.82mm
Max: 4.00mm Max: 3.88mm
03minutes
07 Disintegration test 02 minutes 47 seconds 02 minutes 28 seconds
05 seconds
08 Friability 0.09% 0.08% 0.11%
Avg: 99.7% Avg: 97.9% Avg: 99.9%
09 Dissolution Min: 99.1% Min: 96.7% Min: 98.99%
Max: 100.3% Max: 98.9% Max: 100.75%
10 Assay 99.8% 100.5% 99.7%

Table 14: Results of impact assessment for power failure

Measured Observation
S.NO Acceptance criteria
parameter Batch-I Batch-II Batch-III
Cutting should be uniform on all sided
without any angular cuts
Physical verification
Embossing should be visible and
of blister after
01 readable and knurling should be Complies Complies Complies
resumption of
proper
power
No pinholes should be when observed
against fluorescent light
All 09 blister should comply with the
02 Leak test Pass Pass Pass
leak test

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 International Journal of Research in Pharmaceutical and Biomedical Sciences ISSN: 2229-3701

Table 15: Results of shrink wrapping after 3 runs

Observation
S.NO Test
Batch-I Batch-II Batch-III
White, flat, circular
White, flat, circular uncoated White, flat, circular uncoated
uncoated tablet with
tablet with “PARA/500” tablet with “PARA/500”
01 Description “PARA/500” debossed on
debossed on one side and plain debossed on one side and plain on
one side and plain on other
on other side other side
side
Identification
02 Complies Complies Complies
By IR
03 Average weight 568.8mg 566.0mg 565.5mg
Avg: 568.84mg Avg: 566.0mg Avg: 565.5 mg
Uniformity of
04 Min: 565.1mg Min: 560.3mg Min: 559.7mg
weight
Max: 572.8mg Max: 573.4mg Max: 573.1mg
Avg: 168.0N Avg: 218.7 N Avg: 198.4N
05 Hardness Min: 156.6N Min: 100.2 N Min: 185.2N
Max: 178.2N Max: 271.2 N Max: 213.3N
Avg: 3.86mm Avg: 3.89mm Avg: 3.83mm
06 Thickness Max: 3.91mm Min: 3.84mm Min: 3.80mm
Min: 3.81mm Max: 3.93mm Max: 3.85mm
03minutes
07 Disintegration test 03 minutes 19 seconds 03 minutes 23 seconds
05 seconds
08 Friability 0.1% 0.07% 0.07%
Avg: 100.2% Avg: 98.9% Avg: 99.5%
09 Dissolution Min: 99.7% Min: 99.6% Min: 98.79%
Max: 100.6% Max: 98.9% Max: 100.32%
10 Assay 100.6% 100.8% 99.4%

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