QC tests for packaging materials are described

1. Packaging Material Testing
Presentation by
Miss Utkarsha Sukhdev Shivsharan
M.Pharm (Quality Assurance)
Assistant Professor
DSTSM’s College of Pharmacy, Solapur

2. Introduction
Packaging
Material
Glass
Plastic
Paper &
Cardboard
Rubber
Metals
Definition: Art & science
of preparing the articles
for transport, storage,
display& use.
1. Primary Packaging
Material
e.g. Bottles, tubes etc.
2. Secondary Packaging
Material
e.g. Cartons, boxes etc.

3. Quality Control Tests for Glass
1. Light Transmission Test
2. Hydrolytic Resistance Test
3. Powdered Glass test
4. Water Attack Test
Type of Glass Material Test Use
Type I Borosilicate
Glass
Powdered
Glass Test
Parenterals
Type II Treated soda-
Lime Glass
Water Attack
Test
Acidic & Neutral Parenterals
Type III Soda-Lime
Glass
Powdered
Glass Test
Not for Parenterals
Type IV or NP General soda-
Lime
Powdered
Glass Test
Oral or Topical Preparations

4. Light Transmission Test
Break the
Container
Cut the specimen
And Wash it
Mount the
specimen in the slit
Place it parallel to
plane of the slit
Light beam is
normal & reflection
takes place
Measure the
transmittance at
290-450nm
Normal
size
Max. % of light
Transmission
Flame
Sealed
Container
Closure
Sealed
Container
1 50 25
2 45 20
5 40 13
10 35 13
20 30 12
50 15 10
Procedure

5. Hydrolytic Resistance Test
Principle :Amount of alkali leached from glass is determined in
this test. The container is filled with pure water and maintained at
specified autoclaving condition for specified time period. The
leached alkalis titrated against the acid at neutralization point it
will give the amount of alkali leached.
Nominal capacity of
container (ml)
Number of containers
to be used
Volume of test
solution to be used
for titration (ml)
Up to 3 20 25
5 or less 10 50
6 to 30 5 50
More than 30 3 100
Wash with CO2 free water
Fill it with CO2 free water (up to
Maximum Volume
Autoclave at 120° C for 60
min
Take sample of water and titrate against 0.01N HCl
Amount of acid required must meet the
specification of IP

6. Powdered Glass Test

7. Water Attack Test

8. TEST FOR ARSENIC
Carry out test on ampoules,
inner and outer surfaces
are washed five times with
distilled water
Prepare a test solution as
described for adequate
ampoules to 50ml
Pipette 10ml of test solution
from combined contents of
all ampoules into flask
Add 10ml of nitric acid and
evaporate to dryness on
water bath
Dry the residue in an oven
At 130‫°ﹾ‬C for 30 min
Cool ,add to the residue to 10 ml
ofhydrazine molybdate reagent
Heat under reflux on water
bath for 20 min
Cool to room temperature.
Determine absorbance of
resulting solution at 840 nm
using 10.0 ml of hydrazine
molybdate reagent as blank
The absorbance of test
should not exceed that
obtained by 0.1ml of
arsenic standard solution.

9. QC Tests for Collapsible Tubes
1. Breakage Test
2. Lacquer Curing Test
3. Flexibility Test
4. Lacquer Porosity Test
5. Lacquer Product compatibility Test
6. External Decoration Test
a. Product Compatibility
b. Metal Particle Test

10. QC Tests for Plastic
Tests comply for non-parenteral preparations
1.Leakage test:
Fill ten container with water. Fit with intended
closures and keep tem inverted at room
temperature for 24 hour. There are no signs of
leakage from any container.
2. Collapsibility Test:
This test applicable to containers. Which are to be
squeezed in order to 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.

11. QC Tests for Plastic
Water Vapor 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
temperature between 20°C and 25°C.
Reweigh the containers. The loss in weight in
each container is not more than 0.2%.

12. QC Tests for Plastic
Plastic containers for ophthalmic preparations
comply with the following tests:
1 Leakage test; Collapsibility test Clarity of
aqueous extract; Non- volatile residue Comply
with the tests described under Plastic
containers for Non- Parenterals Preparations.
2. Systemic injection test; Intracutaneous test
Comply with the tests described under Plastic
containers for Parenteral Preparations.
3. Eye irritation test. This test is designed to
evaluate responses to the instillation of extracts of
material under examination in the eye of a rabbit.

13. QUALITY CONTROL TESTING FOR
CLOSURES
1. Fragmentation test
2. Residue on evaporation
3. Sterilization test
4. pH
5. Self Sealability

14. QUALITY CONTROL TESTING FOR PAPER, PAPERBOARD &
CORRUGATED FIBREBOARD
Physical
1.
Thickness
2.Gramma
ge
3. Bulk
Chemical
1.pH
2.Moisture
content
3.Water
absorbing
4.Water
penetration
5,Water
Penetration
6.Grease
Resistance
7.Ash
content
8.Resistanc
e of Writing
paper to
feathering
Mechanical
1.Tensile
Strength
2.Bursting
strength
3.Tearing
Resistance
4.Folding
endurance
5.Bending
Strength
6.Stiffness
7.Impact
strength
8.Flat Crush
9.Puncture test
Optical
1. Gloss
2.Brightness
3. Opacity
Microbiol
ogical
Fungus
Resistance
Other
1. Odor
2. Ply Separation
3. Reducible
Sulphur
4. Wax
Abstrictiveness
5. Conductivity

15. QUALITY CONTROL TESTS FOR FOILS
1. Strength
2. Peelability
3. Push through capability
4. Opacity
5. Temperature Resistance
6. Sterilizer Resistance
7. Tamper Evidence
8. Formability
9. Compatibility