This document summarizes quality control tests for various pharmaceutical packaging materials including containers, closures, and secondary packaging. It discusses tests for glass, plastic, metal containers as well as rubber, plastic, and metal closures. Specific tests covered include chemical resistance, hydrolytic resistance, arsenic, thermal shock, internal bursting pressure, leakage, transparency, water vapor permeability, and more. Flexible packaging materials like polyethylene, cast polypropylene, bi-oriented polypropylene, polyester, and polyamide are also summarized. The document aims to present an overview of important quality control testing for ensuring the safety and integrity of pharmaceutical packaging.

1. M. Pharm Sem-II
Presentations
QUALITY CONTROLTEST FOR PACKAGING MATERIALS,
FLEXIBLE PACKAGING & EVULATION OF PHARMACUTICAL PACAKGING
MATERIALS
SUBMITTED TO
SAVITRIB AI PHULE, PUNE UNIVERSITY , PUNE
FOR
PARTIALFULFILMENT OF REQUIREMENTS FOR THE AWARDOF
MASTER OF PHARMACY
IN THE SUBJECT
Pharmaceutical Manufacturing Technology
IN THE FACULTYOF SCIENCE ANDTECHNOLOGY
Bhujbal Knowledge City,
MET’s Institute of Pharmacy,
Adgaon, Nashik, 422003.
Maharashtra, India
Academic Year-2021-2022
Presented By-
Hammad Md
Athar
Guided By-Mrs.
Dr S.PAhirrao
mam
1

2. Quality control testsfor:
1.Containers
• Glass container
• Plastic container
• Metal container
• Rubber
2.Closures
• Rubber closure
• Plastic closure
• Metal closure
3.Secondary Packaging
Materials
• Paper
• Carton/carboards
2

3. QC Test For Glass Containers
3
1.Chemical Resistance Test:
USP and IP provide two tests to determine chemical resistance of glass
containers.
1)Powdered glass test
2)Water attack test
2.Hydrolytic Resistance Test
3.Arsenic Test
4.Thermal Shock Test
5.Internal Bursting Pressure Test

4. 1)Powdered glass test
• When the glass is powdered the
leaching of alkali can be enhanced in
the powdered iscritical.
• The principle involved in the
powdered glass test in estimate the
amount of alkali leached form the
glass powder.
• The amount of acid that is
necessary to neutralize the released
alkali.
• It is for type TYPE I,TYPE III and
TYPE IV glasses,while water attack
test is for TYPE II glass only.
Prepare glass sample,wash it,10 gm sample +50 ml
purified water.Autoclave it at 121°C
Cool it and decant in another flask and 15 ml water
and decant it again
Titrate decant solution with 0.02 N sulphuric acid
using methyl red ass indicator, volume of titrant used
is recorded.

5. 2)Water attack test Rinse container thoroughly with water,fill it by
90% with water
Autoclave it at 121°C for 30 min then cool it
and decant.
• Water attack test is for TYPE II glass
only.
• The principle involved in the water
attack test is to determine whether
the alkali leached form the surface of
a container is within the specified
limits or not.
Decanted liquid is titrated with 0.02 N sulphuric
acid using methyl red as indicator and volume
of titrant used is recorded.
5

6. Tests Containers Limits ml of 0.02 N
H2SO4
1. Powdered Glass Test Type I
Type III
Type
NP
1.0
8.5
15.0
2. Water Attack Test type II (100ml of
less) type II (over
100ml)
0.7
0.2
Table shows limit of alkalinity for glass containers:
2.Hydrolytic Resistance Test:(Test 1)
Rinse container with CO2 free water
for 3 times,fill it to particular vol. and
autoclave at 100°C for 10 hrs,allow to
rise temp to 121°C for 60 min then
low down temo to 100 °C
Titrate with 0.01 N HCL using
methyl red as indicator
Perform blank and
measure amount of
HCL consumed
6

7. 3.Arsenic test
For containersintended for aq. Parenterals
Inner and outer
surface of container
is washed properly
with water
Autoclave at 100°C for
10 min
Increase temp. from 100-121°C(20
min) Maintained at 121°C for(60
min)
Containers are cooled
& liquids are
combined and
measured
10ml is taken & to it add
10ml HNO3,dried at
130°C 10ml molybdate
is added & refluxed
Measure absorbance at
840nm& perform blank test
(abs of test solution< absof std
arsenic solution 10ppm)
7

8. 4.Thermal shock test
• Sample container is placed in upright position in tray & tray immersed in hot water for giventime
• Then container is transferred in cold water bath,cracks are examined before and after
test(45°C temp. diff)
Small bottles-60-80 °C
Pin bottles-30-40 °C
5.Internal bursting pressure test
The most common instrument is the American Glass Research increment
pressure tester.
• Bottle is filled with water ,placed inside chamber
• Internal press. automatically raised by series of increment at set time
• Bottle checked at selected press. level until container finally bursts
8

9. QC Test For PlasticContainer
Leakage test:10 containers filled with water & fitted closure,kept
inverted for 24 hrs,passes test if no signs of leakage
Transperancy test:5 containers filled to their nominal
capacity(as per IP 1996),cloudiness of suspension compared
against container filled with water
Water vapour permeability test:Fill five containers with nominal volume
of water and heat seal the bottles with an aluminum foil-poly ethylene
laminate or other suitable seal. Weigh accurately each container and
allow to stand (without any overwrap) for 14 days at a relative
humidity of 60+5% and a temperature between 20 -25 °C.Reweigh
the containers. The loss in weight in each container is not more than
0.2%.
9

10. Collapsibility test:This test applicable to containers. Which are
to be squeezed in order toe remove the contents. A container
by collapsing inwards during use yields at least 90% of its
nominal contents at the required rate of flow at ambient
temperature.
Clarity test:Select unlabelled, portions from suitable
containers, taken at random sufficient to yield a total area of
sample required taking into account the surface area of both
sides. Cut these portions into strips none of which has a total
area of more than 20 cm2. Wash the strips free from
extraneous matter by shaking them with at least two separate
portions of distilled water for about 30 seconds in each case,
then draining off the water thoroughly.
10

11. QC Test For MetalContainer
Take 50 empty tubes filled with ointment base ,sealed and kept
overnight
A metal bacteriological filter assembly is set with filter & heated to the
m.p of ointment base
Base from all tubes squeezed at certain rate & passed through filter
under
vacuum.Wash with CHCL3 and observe particles
11

12. QC Test ForClosures
• To measure the force required to make
hypodermic needle penetrate through
closure
Penetratio
n test
• Vol. of NaOH-NMT 0.3ml
• Vol. of HCL –NMT 0.8ml
• (titration using bromothymol blue
indicator)
• Methylene blue used to check
sealability of container
• Applicable to multidose containers
Alkalinity
or acidity
Self
sealability
test
12

13. Applicable to closures intended to
be pierced by hypodermic needle
Fragmentatio
n
test
• 50 ml sol. Is evaporated at
105°C
• Residue obtained NMT 4mg
Residue
on
evaporatio
n
• Measure light abs. at220-
360nm
• Absorbance NMT 2
Light
absorption
13

14. QC Test For Secondary PackagingMaterials
Cartons:
1.compression:used to asses the strength of erected
package thereby estimating degree of protection that it will
provide to the content
2.Carton opening force:carton should spring open to its
original shape without need for extra force
14

15. Papers and cardboards
1. Moisture content
2. Folding
endurance
3. Air permeability
4. Tensile strength
5. Tear strength
6. Stiffness
7. Bursting strength
15

16. FLEXIBLE PACKAGING
1.- POLYETHYLENE (PE)
• It is the oldest thermoplastic film
It can be: Transparent, Metallized,
• Thickness range between 25µ to 100µ
• Excellent heat sealability
• It is only suitable for flexo printing
• PE is a film with very low barrier properties
• It is only suitable to protect against moisture
• This material is mainly used as an inner layer for laminates
• It is also used as single layer to pack products requiring low
protection like: Frozen vegetables, Frozen Fish, Napkins, …

17. 2.- CAST POLYPROPYLENE (CPP)
• It is very similar to PE but with better machinability properties
• Thickness range between 20µ to 40µ
• It is transparent, but with a more crystalic view compared to PE
• It has very low protection barrier values
• Better printability properties than PE, but still must be printed in
flexo
• Used as simple layer for applications such as toast bread or
cupcakes
• Not used as laminating layer

18. 3.- BI-ORIENTED POLYPROPYLENE (BOPP)
• It is the most used thermoplastic film • Thickness range between 15µ to 40µ (most
between 20µ-30µ) • It can be : transparent, white, opaque, metallized, lacquered, pearly, …
• It has very lower heat sealing properties than PE or CPP • Better barrier properties than
PE or CPP • Excellent printability in flexo • Used as simple- or laminated layer • Used in
Snacks, pasta, dish was powders, biscuits, frozen food, …
4.- (BI) ORIENTED POLYESTER (BOPET - PET)
• Thickness: 12µ (recently found in 8/9µ) • It has no heat sealing capability • Very high
barrier properties • Excellent printability properties • Used as part of a lamination • Used in
Cheese, meat, detergents, coffee, soups, …
5.- ORIENTED POLYAMIDE (OPA)
Most usual thickness: 15µ • It has no sealing properties (needs a sealing layer) • It has
high protection barrier values • Medium printability properties • Used in laminations in
combination (at least) with a sealing layer • Applications: Chesse & meat (thermoforming),
spaghetti, …, • Pharma applications: Mainly in cold forming, …

19. 6. PAPER
It is not (obviously) a plastic film • It has no sealing properties
(needs a sealing layer) • It has no protection barrier values •
Printable in flexo • Used in laminations in combination (at
least) with a sealing layer • Applications: Sachets (Pharma &
Food), bread, Tee, Coffee, …
7.- ALUMINIUM
It is not (obviously) a plastic film • It has no sealing
properties (needs a sealing layer) • It has excellent barrier
properties • Its printability is relatively poor • Used in
laminations in combination (at least) with a sealing layer •
Usually it is combined in a sendwich between a sealing- &
printing layer • Applications: Sachets (Pharma & Food), Tee,
Coffee, …

20. Stability aspect of packaging

21. EVULATION OF PHARMACUTICAL
PACAKGING MATERIALS
Evaluation of closures
.FRAGMENTATION TEST(IP 1996)
• place a volume of water corresponding to nominal volume-4ml in
each of 12 clean vials, close vial with closure and secure caps for
16hrs. • pierce the closure with number 21 hypodermic needle(bevel
angle of 10 to 140c)and inject 1ml water and remove 1ml air
• repeat the above operation 4 times for each closure
•count the number of fragments visible to naked eye
•Total number of fragments should not be more than 10.

22. Evaluation of Plastic
1.Leakage Test Fill 10 containers with water, fit with intended
closures and keep them inverted at room temperature for 24hr.The
test is said to be passed if there is no signs of leakage from any
container.
2. Collapsibility Test This test is applicable to the containers which
are to be squeezed for removing 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.
3.Water Vapour Permeability Test Fill 5 containers with normal
volume of water and heat seal the bottles with an aluminium foil.
Weigh accurately each container and allowed to stand for 14days at
a relative humidity of 60±5% and a temperature between 20 and
25⁰C.Reweigh the containers. The loss in weight in each container
is NMT 0.2% .

23. References:
23
1. Lachman., & Liebarman’s. (2013). Industrial pharmacy ( IV ed.).CBS
Publisher and Distributors.1004-1007
2. Evans, E. R., & Halls, I. H. (2005). Pharmaceutical packaging
technology.(D.
A. Dean, Ed.). Taylor & Francis.182,183,335-337
3. QUALITY CONTROL TESTING OF PACKAGING MATERIALS |
PharmaTutor
4.Indian Pharmacoepia Goverment Of India Ministry Of Health And
Family Welfare(2018). (8𝑡ℎ Ed., Vol. I). The Indian Pharmacoepia
Commission.1025,1057-1060