Quality control of packaging material

PREPARED BY:
MOHAMMAD KHALID
Assistant Professor
Krishna Pharmacy College, Bijnor (UP)
28 March 2020Krishna Pharmacy College, Bijnor 1

 Definition
 Role Of Packaging Material
 QC Test for Containers
 QC Test for Closures
 QC Test for Secondary Packaging Materials
 Conclusion
 Reference

Packaging:
 Packaging is the science, art and technology of
enclosing or protecting products for
distribution, storage, sale, and use
 Quality control of a packaging component
starts at design stage. All the aspects of a
pack development may give rise to quality
problems. It must be identified & minimized
by performing quality control tests.

 QC - backbone of pharmaceutical industry.
 Defects in packaging – harmful for dosage
form
 Quality control of a packaging component
starts at the design stage.
 All aspects of a pack development that may
give rise to quality problems must be
identified and minimized by good design.

The packaging materials are classified into
three classes,
Primary:- ampoules, vials, plastic bottles,
polymer-coated foils.
Secondary:-cartons, labels, leaflets
Tertiary:- Outer cartons, shipper

 Different types of container
materials.
 1. Glass Container
 2. Plastic Container
 3. Metal Container
 4. Rubber

 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

 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
methyl red as an indicator.
 Step 1: • Preparation of glass specimen
 Step 2: • Washing the specimen

 10g of specimen/sample + 50ml of 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
 Limits:
Test Container Vol. of 0.02N H2SO4(ml)
Powdered Type I 1.0
Glass Test Type III 8.5
Type N.P 15
Powdered Type I 1.0
Glass Test Type III 8.5
Type N.P 15

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

Water Attack Type II 1.0
Test Size(ml)-100 0.7
Less than 100 0.2
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.

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

Capacity of container
(corresponding to 90%
average flow volume)(ml)
Volume of 0.01 M
HCL Type I or type II
glass (ml)
Volume of 0.01 M
HCL Type III glass
(ml)
Not more than 1 2.0 20.0
More than 1 but NMT 4 1.8 17.6
More than 10 but NMT20 0.80 8.1

Wash inner and outer surface of container
with D.W. for 5 min.
Test solution is same as that of hydrolytic
resistant test (50ml)
Pipette out 10 ml and add 10ml of nitric acid on
the water bath maintaining the temperature
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.

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 auto-
matically raised by
series of incre-
ment at set time
Bottle are checked
at preselected
pressure level until
container finally
burst.28 March 2020Krishna Pharmacy College, Bijnor 15

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

Quality
Control
test for
Plastic
Container
Leakage
test
Collapsib-
lity
Transp-
arency
Water
vapour
permeab-
ility test
Bacteri-
ological
test

 Take 50 empty tubes filled with ointment
base, sealed & kept over night.
 A metal bacteriological filter assembly
fitted with filter paper & heated to
melting range of ointment base
 Base from all tubes squeezed at certain rate &
passed through filter under vaccum. further
wash with CHCL3 and observed for particles.
STEP-1
STEP-2
STEP-3

Observations:
Particles 1mm and above 50
Particles 0.5mm to 1mm 10
Particles 0.2mm to 0.5mm 2
Particles less than 0.2mm Nill
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

QUALITY CONTROL FOR METALLIC TINS:
Protocols of test:
Dimensions:
Limit: Specimen metallic tins with
tolerance 170mm 10mm.
Diameter:
Inner diameter:
- Limit: It should not be less than 98mm.
Outer diameter:
– Limit: NMT 105mm

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

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.

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

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

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

 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
Limit: No. of fragments – NMT 10(in case of butyl rubber)
No. of fragments –NMT 15

 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

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

20ml of sample solution
+ 1M sulphuric acid
20ml of sample solution
+ 0.002M
Potassiumpermagnet
Boil for 3 min. and cool it
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

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.

 The test pieces for paper & board are
conditioned for the tests to be carried out in
standard conditions.
 Those conditions are
 Temperature - 23C  1C
 Relative humidity – 50%  2%

Name of the Test Description
Moisture content All the substances will be measured at temperature specified for test
Folding Endurance Fold the test piece back & forth until rupture occurs
Density of paper & board For rigid cellular materials
Method for determining air
permeability
Expressed in m pa-1s-1. It is important for using lightweight uncoated
paper on machine having vacuum pick up system
Grammage or substance
(g/m2)
The weight of material per unit area of sample
Paper Caliper Single sheet thickness between one surface and other
Tensile strength
The maximum tensile force per unit width that a paper or board will
withstand before breaking
Tear strength
The mean force required to continue the tearing of an initial cut in a
single sheet of paper
Burst strength
The maximum uniformly distributed pressure, applied at right angles
to surface that a test piece of paper & board will stand under
conditions of test. Hydraulic pressure is applied to diaphragm, bulging
it until test piece bursts.
Puncture resistance Energy required to make initial puncture
Stiffness of thick paper &
boards
Degree of resistance offered by paper/board when it is bent
Creasibility of boards
Method to determine creasing quality of board within the range of 300-
1000 m
Cobb test(g/m2) Test for water absorbency

Rub resistance
This is resistance of printed test piece to withstand rubbing against
another similar test piece
Pick test/IGT test
A specified amount of a special oil is added to the printing system &
printed on to the test piece. The surface is then examined for signs of
pick.
pH, chloride or sulphate
The acidity or alkality (pH) can help the life of
the paper board
Roughness/smoothness
This is very important for ‘printablity’ of the
paper.
Brightness
This is the reflectance factor measured at the
effective wavelength of 457 nm
Opacity
This is ratio expressed as percentage of luminous reflectance factor of a
single sheet of paper with a black backing to intrinsic luminous
reflectance factor.
Dennison wax test This is a older test and was replaced by the IGT test
Wet burst strength
It is used to determine wet bursting strength of any paper or board
following immersion in water
Wet tensile strength It is to determine wet tensile strength on immersion in water
Ash in paper & board This is a method of determining the ash content in paper & board
Detection & estimation of
nitrogenous agents in paper
It applies only to substances that have a strong affinity for acid dyes
Ink absorbency The determination of ink absorbency of paper & board by K & N ink.

 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

 Compression:
This method is used to assess the strength of
erected package
 Carton opening force:
The method is used to hold the flat carton as
delivered, by its creases between thumb & first
finger press.
 Coefficient of friction:
Both static & kinetic coefficients of friction are
determined by sliding the specimen over itself under
specific test conditions.
 Crease stiffness:
This involves testing a carton board piece & folding
it through 90. It will then try to recover its former
position when bending force is removed.
 Joint shear strength:
This is a method of testing the glued lap seam on
the side of a carton for strength of the adhesive
using a tensile testing machine.

 Package for a specific drug will preserve the
drugs efficacy as well as its purity, identity,
strength and quality for its entire shelf life.
 It is mandatory for the manufacturers to
prove the safety of packaging of material by
performing the quality control tests as per
the specification.

 Pharmaceuticals Packaging Technology, Taylor and Francis by Dean
D.A, Evans E.R fifth edition page no. 188-189.
 Quality Control of Packaging Materials in the pharmaceutical
Industry-Kenneth, Harburn.
 Pharmaceutical Packaging Technology by D.A. Dean, L.R. Evans,
I.H. Hall.
 The Theory and Practice of Industrial Pharmacy by Leon Lachman
A. Liberman, Joseph L.Kanig IIIrd edition
 Indian Pharamacopoeia 1996 volume II page A- 127, 131,132
 British pharmacopoeia volume IV, page A- 355
 European pharmacopoeia volume I, page- 301
 United states pharmacopoeia 2004, page-2288
 www.googleimagesearch.com
 “Packaging”; Cooper and Gunn’s Tutorial Pharmacy, sixth edition,
CBS publicashers page no. 139-140

Quality control of packaging material

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