m.pharm analysis, pharmaceutical analysis, food analysis, cosmetic analysis and evaluation, modern bio analytical techniques, advanced pharmaceutical analysis, phamaceutical validation

1. Quality control test for containers, closures and
secondary packing materials
SUBMITTED TO:
DR. C. SREEDHAR
PROFESSOR AND HOD
DEPT. OF PHARMACEUTICAL
ANALYSIS
KARNATAKA COLLEGE OF
PHARMACY
BANGALORE
SUBMITTED BY:
S.GOKULRAJ
M PHARM 2nd SEMESTER
DEPT.OF PHARMACEUTICAL
ANALYSIS
KARNATAKA COLLEGE OF
SUBJECT: QUALITY CONTROL AND QUALITY
ASSURANCE
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2. CONTENT
 Introduction of packing
 Types of packing materials
 Quality Control Test for Containers
 Quality Control Test for Closures
 Quality Control Test for Secondary Packaging
Materials
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3. Introduction of packing
 Packaging is the science, art and technology of enclosing or protecting
products for distribution, storage, sale and use.
 Any material that is used for packaging of products for their distribution and
sale is said to be packing material.
 Composition of package:
A. Container
B. Closure
C. Carton or outer box
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4. Types of Packing materials
1. Primary packing:-
 comes in direct contact with the product e.g. bottles, vials, ampoules,
tin, etc.
2. Secondary packing:-
 used to cover primary packs e.g. cartons, boxes, etc.
3. Tertiary packing:
 Transport shipping,warehouse storage,bulk handling.
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5. CONTAINERS
 It is refers to storage media in which product is
placed and enclosed & it is in direct contact with
drug.(glass and plastic)
 Different types of container materials.
1. Glass Container
2. Plastic Container
3. Metal Container
4. Rubber
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6. Quality Control Test for Containers
 QUALITY CONTROL TESTS FOR GLASS
CONTAINERS:
Types of glass:
 Type-I : neutral or borosilicate glass
 Type-II : treated soda lime glass
 Type-III :soda lime glass
 Type-IV :general purpose soda lime glass
Tests:
A. Powdered glass test
B. Water attack test
C. Hydrolytic resistance test
D. Arsenic test
E. Thermal shock test
F. Internal bursting pressure test
G. Leakage test
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7. Powdered glass test
 It is done to estimate the amount of alkali leached from the
powdered glass, which happens at elevated temperatures.
Sample containers are rinsed with purified water and dried
The containers are grinded in a mortar to a fine powder and
passed through sieve no. 20 & 50
10 gm of the sample is washed with acetone and dried
50 ml of purified water is added to the dried sample and
autoclaved at 121°C 30 min and cooled and decanted
The decanted liquid is titrated with 0.02N H2SO4 using methyl
red as indicator
Record the volume of 0.02N H2SO4
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8. Water attack test
 This test is for type II glass. The principle involved in this
is whether the alkali leaches from surface of container.
 The container is rinsed thoroughly with high purity water.
It is then filled with water upto 90% of its capacity
 It is then autoclaved at 121°C for 30 min. Then it is
cooled and liquid is decanted
 Decanted liquid is titrated with 0.02N H2SO4 using
methyl red as an indicator
 The volume of H2SO4 consumed is recorded and
compared with limits
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9. Hydrolytic resistance of glass
containers
Each container is rinsed at least three times with CO2 free water
and filled with the same to their filling volume.
Vials and bottles are covered and autoclaved at 100°C for 10
mins.
The temp. is risen from 100°C to 121°C over 20 mins.
The temp. is maintained at 121°C to 122°C for 60 mins.
The containers are cooled and the liquids are combined and
volume measured.
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10. Arsenic test
This test is for glass containers intended for aqueous
parenterals.
The inner and outer surface of container is washed with fresh
distilled water for 5 min.
Then similar steps are followed as performed in the hydrolytic
test,previously described, till obtaining the final combined
solution.
10ml from the final combined volume is pipetted out and to it 10
ml of HNO3 is added and dried in an oven at 130°C.
10ml of hydrogen molybdate is added and refluxed for 25 mins.
It is cooled and absorbance is measured at 840nm.
The absorbance of the test solution should be less than the
absorbance obtained using 0.1ml of arsenic standard solution
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11. QUALITY CONTROL TEST FOR PLASTIC
CONTAINERS
 Plastic containers are light in weight and non-breakable, but they have high
permeability for water vapour.
 Indian pharmacopoeia prescribes Leakage test for plastic containers.
 These test are applicable for both injectable and non-injectable.
 Water vapour permeability test of Indian Pharmacopoeia is applicable for
injectable preparation.
 TESTS:
A. Water vapour permeability
B. Light transparency test
C. Clarity or aqueous extract
D. Leakage test
E. Collapsibility test
F. Transparancy test
G. Biological test
a) System injection test
b) Intra cutaneous test
c) Eye irritation test on rabbits
H. Resistance to stress
I. Resistance to temperature variation
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12. WATER VAPOUR PERMEABILITY (IP 1996)(only
applicable for injectable preparation)
Fill 5 containers with normal volume of water and seal
the bottle with aluminium foil
Weigh each container
Allow to stand for 14days at RH of 60 ±5% at 20° to
25°C
Reweigh the container and check loss of weight in
each container should not be more than 0.2%
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13. LIGHT TRANSPARENCY TEST
 The observed light transmission for plastic containers for
products intended for oral or topical administration does
not exceed 10% at any wavelength in the range from
290nm to 450nm.
 This test is to determine the effect of light passing
through the bottle wall on the product stability and
appearance.
APPARATUS:
 Spectrophotometer, adapted for measuring the amount
of light transmitted by either transparent or translucent
glass or plastic materials.
PROCEDURE:
 Cut circular sections from 2 or more areas of the
container. Wash and dry each sample taking care not to
scratch the surfaces.
 Mount the specimen on the Spectrophotometer and
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14. CLARITY OF AQUEOUS EXTRACT
Select unlabelled portion from a suitable containers
Cut these portions into strips and Wash it with
extraneous matter by shaking with two separate
portions of distilled water for about 20sec.
after Transfer to flask - previously washed with
chromic acid mixture - and rinsed with distilled water
add 250ml distilled water and Cover the flask and
autoclave at 121°C, 30min.
carry out the blank determination using 250ml dist.
Water.
Cool and examine the extract, it should be Colourless
& free from turbidity.
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15. Leakage test:
 10 containers are filled with water and fitted with
intended closures.
 They are kept inverted at room temperature for 24
hours.
 The test is said to be passed if there is no sign of
leakage from any container.
Collapsibility test:
 This test is applicable to containers which are to be
squeezed in order to remove the contents.
 A container by collapsing inward during use, yield at
least 90% of its normal contents at the required rate
of flow at ambient temperature
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16. CLOSURES
 It is a device tightly pack the container to exclude O2,
CO2, moisture, microorganism, prevent loss of water
and volatile substance from the product during
transport and handling.
 It is part of container system but does not come in
contact with drug.(aluminium, rubber)
Different types of materials used for closures
 Rubber closures
 Plastic closures
 Metal closures
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17. Quality control test for closures
1. Residue on evaporation
2. pH of aqueous extract
3. Reducing substance test
4.Sterility test
5. Fragmentation test
 For aqueous preparations
 For dry preparations
6.Light absorption test
7. Penetrability test
8.self-seal ability
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18. Preparation of sample
The closures are washed in 0.2% w/v of anionic
surface active agents for 5 mins
Rinsed five times with distilled water and 200ml water
is added
Subjected to autoclave at 119°C to 123°C for 20-30
mins covering with aluminum foil
Cooled and solution is separated from closures
(Solution A)
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19. 1. Residue on evaporation:
 50ml of Solution A is evaporated to dryness on a water
bath and dried at 105°C.
 The residue weighs not more than 4 mg.
2. Sterility test
 Container closure integrity testing (CCIT) is an assay that
evaluates the adequacy container closure systems to
maintain a sterile barrier against potential contaminants.
Closures are subjected for sterilization
Autoclaved at 64-66°C and pressure 0.7kPa
Further testing is carried out by using culture media
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20. 3.pH of Aqueous extract
20 ml of sample solution is taken and 0.1 ml of
bromothymol blue is added to it
The sample solution is titrated with 0.01M NaOH till
colour changes from blue to yellow
Volume is measured after the colour change
Limits:-
 Volume of NaOH - not more than 0.3 ml
 If HCl is used - not more than 0.8 ml
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21. 4.Reducing substance test
20ml of sample solution + 1M H2SO4 + 0.002M KMnO4
Boiled for 3 min and cooled down
Add 1 gm of Potassium iodide
Treat the solution with Sodium Thiosulphate using
starch solution as indicator
Blank titration is done and difference of sample and
blank should be not more than 7.0 ml
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22. Quality control test for secondary
packaging materials
 Quality control test for cartons
1. Compression
2. Carton opening force
 Quality control test for paper and board
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23. Quality control tests for Cartons
1. Compression
 Used to assess the strength of erected package
there by estimating the degree of protection that it
confers on the contents.
 This is useful for products with no inherent strength
in one plane or another.
2. Carton opening force
 The carton should spring open in to its original shape
without a need for unreasonable force.
 If the carton does not spring open buckles in on
itself, it may cause problems on cartooning machine.
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24. Quality control tests for paper and board
Test conditions:
 Temperature- 23°C 1°C;
 Relative humidity- 50%+2%
1. Moisture content
2. Folding endurance
3. Air permeability
4. Tensile Strength
5. Tear Strength
6. Stiffness
7. Bursting strength
8. Density of paper and board
9. Grammage or substance
10. Paper caplier
11. Puncture resistance
12. Stiffness of thick paper and boards
13. Creasibility of boards
14. Cobb test
15. Rub test
16. Pick test/IGT test
17. PH, chloride or sulphate
18. Roughness/smoothness
19. Brightness
20. Opacity
21. Dennison wax test
22. Wet burst strength
23.Wet tensile strength
24. Ash in paper and board
25. Detection and estimation of
nitrogenous agent in paper
26. Ink absorbency
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25. Moisture content test
 Conditioned specimen is weighed and heated to a
constant weight to expel the moisture. The difference
of the two weights gives the moisture content of the
paper.
Folding Endurance
 Fold endurance measures the durability of paper
when repeatedly folded under constant load;
determining how many times the paper can be
folded until it breaks.
 Fold the test piece back and forth until rupture
occurs.
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26. Bursting strength
 The burst test is used as a general guide to the
strength of paper, solid board and corrugated board.
 Bursting strength is usually quoted in kPa.
 We determine bursting strength using digital
hydraulic board burst tester.
Burst index = burst strength/basis weight
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27. THANK YOU
!!!
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