Ramchandra ipqc of packaging material

H. R. Patel Institute of Pharmaceutical
Education & Research , Shirpur
Presented By
Mr. Handal Ramchandra M.
First Year M.Pharm
Department of Quality
Assurance
Guided By
Dr. G. B. Patil
Department of Quality
Assurance

Contents
 Definition
 Role of packaging
 Types of packaging
 Types of raw material used for packaging
 Q.C for Glass
 Q.C for Plastic
 Q.C for Rubber
 Q.C for Collapsible tube
 Conclusion
 References
Analysis of Packing Material Mr. Handal Ramchandra 2

 Packaging
Packaging is the art ,science and technology
of enclosing or protecting products for distribution,
storage, sale and use.
Analysis of Packing Material Mr. Handal Ramchandra
3

Role of packaging
Protection Presentation Identification
Information Convenience
against light
against reactive gases
against moisture
against microbes
against physical damage
against adulteration

Types of Packaging
Analysis of Packing Material Mr. Handal Ramchandara
5

Primary Packaging
Primary packaging is the material that first
envelops the product and holds it. This
usually is the smallest unit of distribution or
use and is the package which is in direct
contact with the contents.
Examples: Glass, plastic, rubber.
Analysis of Packing Material Mr.Handal Ramchandara 6

Analysis of Packing Materail Mr. Handal Ramchandra
77IN-PROCESS INSPECTION DURING PRIMARY
PACKAGING OPERATION
For bottle/sachet packaging operation
Inspect the empty containers and closures for some physical defects
Carry out the leak test at the start of operation and then at
regular interval not exceeding 2 hours.
If leak test is
OK
If leak test is
not OK
Inform the
packaging officer
for machine
setting
Inspect bottle/ sealing of sachet/tablet defects etc.

Secondary Packaging
Secondary packaging is outside the primary
packaging perhaps used to group primary packages
together.
Example: Cardboard cartons, cardboard boxes
8

Tertiary Packaging
Tertiary packaging is used for bulk handling,
warehouse storage and transport shipping.
Examples: Brown cardboard boxes, wood pallets
9

Types of Raw Material Used For
Pharmaceutical Packaging
Types Use
1. Glass Bottles ,Vials, Ampoules, Syringes, etc.
2. Plastic Bottles, Syringes, Bags, Tubes.
3. Rubbers Closure, Vials Wrappers, Cap, Plungers
4. Paper Label, Pouches, Cartons, Paper Drum.
5. Metals Collapsible tubes ,Foils ,Canes, Aerosol.

Glass1
11
Advantages of glass containers:
• They are transparent.
• They can withstand the variation in
temperature and pressure during
sterilization.
• They can protect the photosensitive
medicaments from light during storage.
• They are neutral after proper treatment.
• They are impermeable to moisture and
other gases.

Disadvantages of glass containers
 Glass is fragile, so its containers are easily broken
when dropped or knocked.
 Glass container are heavy.
 Glass container may release alkali to aqueous preparation.
Analysis of Packing Material Mr. Handal Ramcahndra
12

Quality Control Test For Glasses
1. Chemical resistant of glass containers
A. Powder glass test .
B. Water attack test.
2. Hydrolytic resistant of glass containers .
3. Light transmission test.
4. Arsenic test.
5. Thermal shock test.
6. Internal bursting pressure test.
7. Leakage test.
Analysis of Packing Materail Mr. Handal Ramchandra 13

Types of glass and their limits
Analysis of Packing Material Mr.Handal Ramchandara
14
Type of
glass
General
descriptio
n of glass
Type of
test
Limit size,
ml
Limits (ml
of 0.02 N
acid)
I Highly
resistant
borosilicate
glass
Powdered
glass
All 1.0
II Treated soda-
lime glass
Water attack 100 or less,
Over 100
0.7
0.2
III Soda lime
glass
Powdered
glass
All 8.5
IV General
purpose soda
lime glass
Powdered
glass
All 15.0

Types of glass (USP)
Type General
description
properties suitability
I Highly resistant,
borosilicate glass
Alkalinity is removed by using boric
oxide to neutralize the oxides of
potassium & sodium.
Preparation for
parenteral
administration.
II Treated soda-
lime glass
Obtained by treating the hot surface of
Type III glass by sulphur
dioxide/ammonium
sulphate/ammonium chloride
Preparation for
parenteral
administration.
III soda-lime glass It is an alkaline glass having high
percentage of lime & soda & no boric
oxide as compared to Type I glass.
Not generally used
for parenteral
preparations until &
unless indicated.
NP General purpose
soda-slime glass
It has similar composition to that of
Type III glass but there is no guarantee
of similar properties.
Non parenteral
products (oral or
topical use).
15

Rinse and dry 6 or more containers. Crush into fragments.
Divide 100g of coarsely crushed powder into 3 equal parts and
place one portion in mortar.
Powdered glass test
A) Preparation of specimen:
Crush further by striking 3-4 blows with
hammer
Nest the sieves & empty the mortar into 20#sieve
Spread the specimen on glazed paper and remove iron particles
with the help of magnet. 16
Shake the sieve and remove the glass from
20#sieve
16

Wash with six 30ml portions of acetone
Decant the acetone & dry the contents for 20 min.at140°c
Transfer to weighing bottle & cool in a desiccator.
Final specimen to be used in powder glass test.
17

B) Powdered glass test(USP):
Transfer 10g of prepared specimen in a 250 ml conical flask digested
previously with high purity water in bath at 90°c
Decant water& wash residual powdered glass
Reduce the heat& wait for autoclave to cool &cool the flask
Autoclave (Continue heating for 10 min)&Close vent cock . Adjust
temperature to 121°C &Hold the temp(121°C ±2°C for 30 min)
Add to conical flask containing 50ml of high purity water & Cap all
flasks.
Add the decanted washing to main portion
18

Volume doesn’t exceed that indicated in table for type of glass
concerned.
Record the volume of 0.02N sulphuric acid.
Titrate immediately with 0.02 N sulphuric acid
Add 5 drops of methyl red solution
19

Water attack test (USP)
Empty the contents & transfer the contents in 250ml conical flasks to a
volume of 100ml
Add 5 drops of methyl red solution
Titrate with 0.02N sulphuric acid while warm
Cap all the flasks & autoclave for 60 min
Fill each container to 90% of its overflow capacity
Rinse 3 or more containers twice with high purity water
20

Volume should not exceed that indicated in table for type of glass
concerned.
Record the volume consumed (corrected for blank obtained by
titrating 100ml of high purity water at same temp & same amount of
indicator)
21

Plastic container for pharmaceutical product are
made from plastic based polymer such as
polyethylene ,polypropylene, polyvinyl chloride.
The containers consist of one or more polymer
together with certain additives if necessary.
Analysis of Packing Material Miss .Shweta Baviskar
22
Plastic2

Advantages:
1.Very good mechanical strength.
2.Poor conductor of heat.
3.Low freight cost due to less weight.
4.Non breakable.
Disadvantages:
1.Drug –plastic interaction may occur due to
presence of many additives.
2.Permeated by vapors.
23

Test for plastic containers
For non-injectable preparations
1) Leakage test
Fill 10 container with water & fit the closure
Keep them inverted at RT for 24 hrs.
No sign of leakage form any container.
2) Collapsibility test
This test is applicable for those containers, which have to be
squeezed for the withdrawal of the product.
A container by squeezing yields at least 90% of its nominal
content at required flow rate at ambient temp.
24

For injectable preparations
1) Water vapour permeability test
Fill 5 containers with nominal volume of water & seal
Weigh each container & allow to stand for 14 days at RH 60 ±
5% at 20° to 25°C
Reweigh the container
Loss of weight in each container should not be more than 0.2%
25

Solution S :
1) Fill the container to its nominal capacity with water and
close it with the help of sheet of pure aluminium.
2) Heat in an autoclave so that a temperature of 121 ± 2°C
is reached within 20 to 30 min & maintain at this temp for
30 min.
3) Use the solution S within 4 hours of preparation.
Blank :
Prepare a blank by heating water in a borosilicate glass
flask closed by sheet of pure aluminium at same temp &
time used for the preparation of solution S.
Analysis of Packing Material Mr. Handal Ramchanndra
26

2) Acidity or alkalinity
To a volume of solution S corresponding to 4 % of the
nominal capacity of the container add 0.1 ml of
phenolphthalein solution.
The solution is colourless. Add 0.4 ml of 0.01 M NaOH.
The solution is pink.
Add 0.8 ml of 0.01 M HCl & 0.1 ml of methyl red solution.
The solution is orange – red or red.
27

3) Reducing substances
To a 20 ml of solution S add 1 ml of dilute sulphuric acid & 20
ml of 0.002M potassium permagnet .
Boil for 3 min &cool immediately ,add 1g of potassium iodide
Titrate immediately with 0.01M sodium thiosulphate, using
0.25ml of starch solution.
Carry out the titration using 20.0 ml of blank solution, the
difference between the titration volume not more than 1.5ml
28

4) Transparency test
Fill 5 container with diluted suspension their nominal capacity
Cloudiness of diluted suspension in each container is
detectable
By comparing with same container filled with water.
5) Light absorption test
The light absorption in the range 230nm to 360nm of
solution S using a blank prepared as described under
solution S is not more than 0.20
29

Rubber1
 Rubber consist of several ingredients, one of
which is an elastomer.
 Rubber compounds used in pharmaceutical
packaging contain only limited number of
ingredients, which are difficult to extract.
 These closure do not pose a problem & can
be used in contact with a large number of
drug preparations.
Analysis of Packing Material Mr.Handal Ramchandra
30

Test for rubber closures
1)Fragmentation test
2)Self sealability test
3)Extractive test
4)Compatibility test
31

1) Fragmentation test
Place a volume of water corresponding to nominal volume minus
4ml in each of 12 clean vials.
Close a vial with closure & secure cap for 16hrs
.
Pierce the closure with 21 SWG hypodermic needle & inject 1ml
water & remove 1ml air.
Repeat the above operation 4 times for each closure
Count the no. of fragments visible to the naked eye.
Total no. of fragments should not more than 10 (Except butyl
rubber where fragments should not exceed than 15)
Analysis of Packing Material Mr.Handal Ramchandara
32

2)Self sealability test
 Fill 10 vials with water to nominal volume and close the vials with
closure , secure the cap.
Pierce the cap 10 times at different site with 21 SWG hypodermic
needle.
Immerse the vials 0.1%w/v soluation of methylene blue under
reduced pressuer (27 Kpa)for 10 min.
Restore the normal pressure and keep the container immersed for 30
min.& wash the vials
None of the vials should cintain trace of colored trace of colored
soluation.
Note : Test is applicable to multidose containers only.

2)Extractive test
• In this test, the closure is boiled with water for 4 hours
under reflux & The water evaporated to dryness.
The residue must not exceed the specified amount.
3) Compatibility test
• This test is performed to check the compatibility of the
rubber closures with various types of the substances.
• Since it is necessary to ensure that there is no interaction
between the contents of the bottle & the closure.
34

Quality Control Of Collapsible Tubes
1. Leakage test.
2. Lacquer curing test.
a) Power of adhesion.
b) flexibility test.
3. Lacquer compatibility test.
a) Product compatibility.
b) Lacquer compatibility.

Leakage test :
Water was filled in the tube & tightly closed.
The tube is kept inverted on filer paper at base. allow to stand
for 1 hr .
Filter paper shows absorption at anytime during test period.
Power of adhesion :
Tube was spitted along the length & flattened.
Then cotton wool soaked in acetone was rubbed over lacquer
surface for 20 min.
Lacquer should not lift from surface & cotton wool shall
remain colourless.

Flexibility test :
The tube was folded in such a manner that internal
lacquer surface is outside.
The lacquer coating should not be peeled off when
the holded position is rubbed with finger.
Product compatibility test :
Content should not show any discolouration or
change in colour or gas formation.
37

Conclusion
 Packaging plays an important role in
pharmaceutical industries.
 Packaging has a great role in protection of
pharmaceutical product.
 The testing of packaging materials is
almost requirement for any pharmaceutical
industry.
 The material of package affects quality,
safety and efficacy of the drug product.
38

Reference
 N.K.Jain “Pharmaceutical Product
Development”, Second edition, CBS
Publication 2011 , Page no.427- 464.
 “Indian Pharmacopoeia”, 2014, Government
of Indian ministry of health and family
welfare, The Indian pharmacopoeia
commission, Ghaziabad, volume-I, 6.1, 6.2,
6.3, 889- 893.
39

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