Packging material

1. • PRESENTD BY :-
• PATIL PRANJAY SADASHIV.
• FIRST YEAR M.PHARM.
• DEPARTMENT OF QUALITY ASSURANCE.
H. R. Patel Institute of Pharmaceutical Education
and Research, Shirpur
PACKGING MATERIAL

2. • 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
Conclusion
References

3. • Packaging
Packaging is the art ,science and technology of
enclosing or protecting products for distribution, storage,
sale and use.

4. Role of packaging1
Protection Presentation Identification
Information Convenience
against light
against reactive gases
against moisture
against microbes
against physical damage
against adulteration

5. Types of Packaging

6. 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.

7. 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.

10. Glass1
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.

11. 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.

12. Types of glass and their limits
Type of
glass
General
description
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

13. 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. 13
Shake the sieve and remove the glass from 20#sieve

14. 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.

15. 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

16. 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

17. 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

18. 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)

19. 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.
Plastic2

20. 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.

21. 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.

22. 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%

23. 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.

24. 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.

25. 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

26. 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

27. 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.

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

29. 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)

30. 3) 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.
4) 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.

31. 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.

32. Reference
 Jain N. K, “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.