This document describes quality control tests for various pharmaceutical packaging materials including containers, closures, and secondary packaging. It provides details on tests for glass, plastic, and metal containers to evaluate properties like chemical resistance, leakage, hydrolytic resistance, and thermal shock resistance. Tests for closures examine sterility, fragmentation, self-sealability, pH, and absorption. Secondary packaging materials are tested for moisture content, folding endurance, air permeability, tensile strength, and burst resistance. The document provides testing methodologies and acceptance limits for ensuring packaging integrity and suitability for drug products.

1. 12/8/2018Quality Control Test 1
Sanjivani College of Pharmaceutical Education and
Research, Kopargaon
Prepared by
Miss Unnati .M. Patel
F.Y.M Pharm(PQA)
Guided by
Dr A.D.Kulkerni
MPharm(Pharmaceutics)

2. 12/8/20182
CONTENT
1. QC Test for Containers
2. QC Test for Closures
3. QC Test for Secondary Packaging Materials
Quality Control Test

3. 12/8/20183
QUALITY CONTROL TEST FOR CONTAINERS
Quality Control Test
 Different types of container materials.
1. Glass Container
2. Plastic Container
3. Metal Container
4. Rubber

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Quality Control Test for Glass Containers
1. Chemical Resistance Test
a) Powdered Glass Test
b) Water Attack Test
2. Hydrolytic Resistance Test
3. Arsenic Test
4. Thermal Shock Test
5. Internal Bursting Pressure Test

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1. Chemical Resistant Test
a) Powdered Glass Test: It is done to estimate the
amount of alkali from powdered glass with happen at
elevated temperature. When glass is powdered,
leaching of alkali is enhanced, which can be titrated
with 0.02N sulphuric acid using methylred as an
indicator.
Step 1
• Preparation of glass specimen
Step 2
• Washing the specimen

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10g of specimen/sample + 50ml oh highly
purified water.Autoclave it at 121̊C.
Cool it and deacant solution in another flask
again add 15ml water and decant solution
Titrate the decant solution with 0.02N sulphuric
acid using indicator and record the volume
Test Container Vol. of 0.02N
H2SO4(ml)
Powdered
Glass Test
Type I
Type III
Type N.P
1.0
8.5
15
Limits:

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b) Water Attack Test: This test is for Type II glass. The
principle involve in this is whether the alkali leaches from
surface of container.
Rinse thoroughly container with high purity
water. Fill it by 90% of it’s capacity with water.
Autoclave it at 121̊C for 30 minutes. Then it is
cooled and liquid is decanted
Decanted liquid is titrated with 0.02N Sulphuric
acid using methylred as an indicator
The volume of sulphuric acid consumed is
recorded and compare with limits

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Test Container Vol. of 0.02N
H2SO4(ml)
Water Attack
Test
Type II
Size(ml)-100
Less than 100
1.0
0.7
0.2
Limits:
2. Leakage Test:
 Drug filled container is placed in contained filled with
colored solution (methyleneblue) and autoclave at 121̊C for 10
min. under pressure.
Later on the container are observed whether colored get
entered in container or not.

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3. Hydrolytic Resistant Test
 This test is only for unused glass container.
At 100̊C for 10
min. allow to
rise temp. to
121̊C for 60 min.
Low down temp
to 100̊C. Cool it
Rinse the
container with
CO2 free water
for 3 times. fill
till a particular
vol. autoclave it
Specific amount
of liquid solution
is titrated with
0.01N HCL
using methylred
as an indicator.
Perform the blank with water
and difference between the
titration represents vol. of
HCL consumed by test liquid

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Limits

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Wash inner and outer surface of container with
D.W. for 5 min.
Dry residue in oven at 130̊C for 30 min. & cool it
& add hydrogen molybdate & refux for 25 min.
Cool the solution and determine absorbance at
840nm. Perform blank.
Pipette out 10 ml and add 10ml of nitric acid on
the water bath maintaing the temperature.
Test solution is same as that of hydrolytic
resistant test (50ml)
4. Arsenic Test

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Limits: The absorbance of test solution should not exceed the
absorbance of arsenic standard solution of 10ppm.
5. Internal Bursting Pressure Test
Instrument used American glass research increment pressure tester.
The test bottle is
filled with water
and placed inside
test chamber
The internal
pressure
automatically raised
by series of
increment at set
time
Bottle are checked
at preselected
pressure level until
container finally
burst.

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6. Thermal Shock Test
Step 1
• Place sample container in upright position in tray &
immersed tray in hot water for a given time.
Step 2
• Transfer the container in cold water bath temp.
should be controlled. Examine cracks before & after
test.(45̊C temp. difference should be there.)
Step 3
• The amount of thermal shock a bottle can
withstand is based on construction.
•Small bottles- 60 - 80̊C
• Pint bottles- 30-40 ̊C

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Quality
Control
test for
Plastic
Container
Leakage
test
Collapsibi
lity
Transpare
ncy
Water
vapour
permeabilit
y test
Bacteriolog
ical test

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Quality Control Test for Metal Container
• Take 50 empty tubes filled with ointment base,
sealed & kept overnight
Step 1
• A metal bacteriological filter assembly fitted
with filter paper & heated to melting range of
ointment base.
Step 2
• Base from all tubes squeezed at certain rate &
passed through filter under vaccum. further
wash with CHCL3 and observed for particles.
Step 3

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Observations
Particles 1mm and above 50
Particles 0.5mm to 1mm 10
Particles 0.2mm to 0.5mm 2
Particles less than 0.2mm Nil
Total score 62
Limits :
 Lot of tube passes test if total score is less than 100.
 Lot of tubes fails if total score is above 150
 If it is between 100 – 150 test is repeated again with 50 more tubes

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Quality Control Test for collapsible tubes
Quality Control Test for
collapsible tubes
Leakage Test
Power of
Adhesion
Flexibility Product
compatibility

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Quality Control Test for Strip and Blister packing
3/4th of water is poured in
desiccator. Strip and Blister
were placed inside
desiccators and vaccum is
applied
Later on strips, blisters
were taken out. water
present over the outer
surface were wiped out.
The content of strips and
blisters were removed
and presence of moisture
was checked
If there is no leakage,
content will not be
wetted. It indicate
perfect sealing.

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QUALITY CONTROL TEST FOR CLOSURES
1. Sterility Test
2. Fragmentation Test
3. Self-Sealability
4. pH of aqueous extract
5. Light Absorption Test
6. Reducing Substance
7. Residue on Evaporation
8. Penetrability
Quality Control Test

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 Preparation of sample solution
Wash closure in 0.2%w/v of anionic
surfactant for 5 min.
Rinse 5 times with D.W. and add
200ml water.
Further subjected to autoclave and
covering with Al foil.
Allow to cool and separate solution
from closure
Quality Control Test

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1. Sterility Test
Closures are
subjected for
sterilization
By Autoclaving
at 64-66 C &
pressure 0.7kPa
Further testing is
carried out by
using culture
media.
Quality Control Test

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Take 12 clean vials and
place closures containing
4ml of water
Allow to stand for 16 hrs.
Use hypodermic needle to
inject 1ml of water into the
vial & remove 1ml of air.
Carry this operation for 4
times with new needle
each time.
Pass the water present in
vial through a filter with
pore size of 0.5µm
No. of fragments of
closure retain should be as
per the limits
2. Fragmentation Test
Limit: No. of fragments – NMT 10(in case of butyl rubber)
No. of fragments –NMT 15
Quality Control Test

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3. Self-Sealability
Fill 10 vials
with nominal
volume of water
and place
closures.
Pierce cap for
10 times at
different sites
with
hypodermic
needle
Immerse vials
in 0.1%w/v
solution of
methylene blue
under pressure
Keep the
container
immersed for
30 minutes
Wash the vials
& none of vials
should contain
traces of color
solution
Quality Control Test

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4. pH of Aqueous Extract
Take 20ml of sample solution and add 0.1ml of
bromothymol blue
Add 0.01M of NaOH till color change from
Blue to Yellow. Volume required is measured
LIMITS: Vol. of NaOH – NMT 0.3 ml
If HCL is used –NMT 0.8 ML
5. Light Absorption Test
 It must be done within 4 hr of preparing sample solution. It is
filtered and its absorbance is measured at 220nm to 360nm.
 Blank is done without closure and absorbance must be
NMT-2.0
Quality Control Test

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6. Reducing Substance
Boil for
3 min.
and cool
it.
20ml of sample
solution + 1M
sulphuric acid
20ml of sample
solution + 0.002M
Potassiumpermagnet
Add 1 Kg of Potassiumiodide
Treat the solution with Na thiosulphate using
starch solution as indicator.
Blank Titration is done and difference of
sample and blank should be NMT-0.7ml
Quality Control Test

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7. Residue on Evaporation
 The 50ml of sample solution is evaporated at 105̊C.
Residue obtained should be NMT 4mg.
8. Penetrability
 This is to measure the force required to make a hypodermic
needle penetrate easily through closure.
 It is measured by using piercing machine.
 The piercing force must not exceed a stated value, the
hypodermic needle can get damage as a result of undesirable
hardness of closure.
Quality Control Test

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QC TEST FOR SECONDARY PACKAGING
MATERIALS
Quality Control Test
 The test pieces of paper and board are taken for test to be
carried out in standard condition
a) Temperature: 23̊C ± 1̊C
b) Relative Humidity: 50% ± 2%
1. Moisture Content
2. Folding Endurance
3. Air Permeability
4. Tensile Strength
5. Stiffness
6. Burst Resistance

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REFRENCES
Quality Control Test
1. Pharmaceuticals Packaging Technology,Taylor and Francis
by Dean D.A, Evans E.R fifth edition
page no. 188-189.
2. “Packaging”; Cooper and Gunn’s Tutorial Pharmacy, sixth
edition, CBS publicashers
page no. 139-140

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