This document discusses various aspects of pharmaceutical packaging. It begins by defining primary, secondary, and tertiary packaging. The objectives of packaging include marketing, identification, protection, and convenience. Selection of packaging depends on factors like content stability and compatibility. Common packaging materials include glass, plastic, rubber, metals, and paper. The document then discusses various packaging types like containers, closures, collapsible tubes, and unit dose packaging. It outlines tests for evaluating different packaging materials and provides an overview of FDA regulations for pharmaceutical packaging.

1. Vani.ch
Vani.CH
I/II M PHARM
Y17MPH0554

2. Introduction:
What is packag?
It is art and science of preparing articles for transport, storage,
display and use.
The selection of a package therefore begins with a
determination of the product’s physical and chemical
characteristics, its protective needs, and its marketing
requirements.
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3. Objectives of packaging
 Marketing potential and presentation of packaging.
 Identification , information, protection.
 Preserves integrity of product.
 Convenience, compliance and containment during storage.
 Brand identity.
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4. Selection of type of pack depends upon its :
 Content stability
 Content reactivity with packaging material(drug compatibility).
 Accessibility of pack to user.
 Packaging process.
 Regularity ,legal, quality issues.
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5. TYPES OF PACKAGING:
Primary packaging is the material that envelopes 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.
Primary packaging :
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6. Secondary packaging
Is outside the primary packaging-perhaps used to group
primary packages together.
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7. Tertiary packages:
Is used for bulk handling, warehouse storage and transport shipping.
The most common form is a palletized unit load that packs tightly into
the container.
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8. Containers and closures
Types of containers
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9. CLOSURE:
A closure is the part of the package which prevent the contents from
escaping and allow no substance to enter the container.
Closures are available in five basic designs
1. Screw on, threaded or lug
2. Crimp on(crowns)
3. Press on(snap)
4. Roll on and
5. Friction
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10. CLOSURE LINERS:
A liner may be defined as any material that inserted in a cap to effect a seal
between the closure and the container.
It is of two types:
1. Homogeneous liners
These are one piece liners available as disk or a ring of rubber or plastic.
It can be withstand high temperature sterilization.
2. Heterogeneous liners
These are composed of layers of different materials chosen for specific
requirements.
It consists of facing and backing. Facing is in contact with product and backing
provides questioning effect. 10

11. Unit dose packaging
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12. Types of unit dose packaging
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13. Packaging materials:
 Glass.
 Plastics.
 Metals.
 Paper and paper board.
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14. MATERIALS USED FOR MAKING OF CONTAINERS:
GLASS-
e.g.bottles,vials,ampules,syringes,i.v containers, aerosol containers.
PLASTIC-
e.g.bottlespouches,tapes,tubes,aerosolcontainers,laminates.
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15. RUBBER-
e.g. closures, caps,vialswrapers,plungers.
Metals-
e.g. collapsabletubes,foils,needles,aerosol containers
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16. Paper or cardboard:
e.g. secondary packaging
labels,inserts,displayunits,pouches,laminates,cartons,carrogated
boxes,foils,paper drums
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17. Composition of glass:
Glass is composed principally of sand, soda ash, lime stone and
cullet.
Sand is almost pure sillica,soda ash is sodium carbonate, lime
stone is calcium carbonate.
Cullet is broken glass that is mixed with the batch and acts as
fusion agent for the entire mixture.
GLASS CONTAINERS:
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18. TYPES OF GLASS
 Type I—Highly resistant borosilicate glass.
 Type II—Treated soda lime glass.
 Type III—soda lime glass.
 NP—soda glass (non parenteral usage).
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19. Glass used in Laboratory vails
Colored Glass
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20. EVALUATION OF PACKAGING
MATERIALS
TESTS FOR GLASS CONTAINERS:
1) Powdered glass test
2) Water attack test
Preparation of specimen for powdered glass test:
Rinse 6 or more containers and dry them
Crushed in to fragments
Divide 100gms of coarsely crushed glass in to
three equal parts 20

21. place 1 portion in a mortar
Crush further by striking 3 or 4 blows with hammer
Nest the sieves (# 20,40 at least)
Empty the mortar in to sieve 20
Shake the sieves and remove the glass particles from # 20 and 40
Crush them again and sieve them
Transfer the retained portion on # 50
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22. Spread the specimen on a glazed paper
and remove iron particles with the help of magnet
Wash with 6 portions of 30ml acetone
Dry the contents for 20mins at 140oc
Transfer to weighing bottle and cool in a desiccator.
Final specimen should be used in powdered glass test
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23. 1) POWDERED GLASS TEST: (according to USP volume 27)
Transfer 10gms of prepared specimen in a 250ml conical flask
digested previously with high purity water in a bath at 90o c
Add to conical flask containing 50ml high purity water
Cap all the flasks and auto clave
Adjust temperature to 150oc
Cold the temperature to 121oc for 30mins
Cool the flasks under running water
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24. Wash the residue powdered glass(4 times with 15ml purity water)
Add the decanted washings to main portion.
add five drops of methyl red solution.
Titrate immediately with 0.02N sulphuric acid.
Record the volume of 0.02N sulphuric acid.
Volume does not exceed i.e. indicated in the USP as per the type
of glass concerned
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25. 2).WATER ATTACK TEST:(USP)
rinse 3 or more containers with high purity water
fill each container to 90%of its over flow capacity
cap all the flasks and autoclave for 60mints
empty the contents and cool 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
record the volume of 0.02Nsulphuric acid consumed
volume should not exceed as indicated in USP as for type of
glass
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26. PLASTIC CONTAINERS:
Plastics are synthetic polymers of high molecular weight.
Plastics as packaging have proved useful for a number of
reasons, including the ease with which they can be formed,
their high quality and the freedom to design.
Plastic containers are extremely resistant to breakage and
offer safety consumers. Two types of plastic are available in
market.
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27. Thermoplastic type :-
On heating, they are soften to viscous fluid which hardens again
on cooling.
e.g. polyethylene ,PVC ,Polystyrene, polypropylene, Polyamide,
Polycarbonate.
Thermosetting type :-
When heated , they may become flexible but they do not become
liquid.
Phenol formaldehyde ,urea formaldehyde, melamine
formaldehyde
TYPES OF PLASTICS:
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28. DRUG-PLASTIC CONSIDERATIONS
A packaging system must protect the drug without altering the
composition of the product until the last dose is removed.
Drug-plastic considerations have been divided into five categories:
1. Permeation
2. Leaching
3. Sorption
4. Chemical reaction
5. Alteration 28

29. TESTS FOR PLASTIC CONTAINERS
1.Leakage test for plastic containers(non injectables and
injectables 1996 IP):
fill 10 plastic containers with water and fit the closure
keep them inverted at room temperature for 24 hrs
no sign of leakage should be there from any container
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30. 2.WATER PERMEABILITY TEST FOR PLASTIC
CONTAINERS(INJECTABLE PREPARATIONS IP 1996):
fill 5 containers with nominal volume of water and sealed
weigh each container
allow to stand for 14 days at relative humidity of 60% at 20-250C
reweigh the container
loss of weight in each container should not be more than 0.2%
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31. COLLAPSIBLE TUBES
Metals:
The collapsible metal tube is an attractive container that permits
controlled amounts to be dispensed easily, with good reclosure,and
adequate protection of the product.
It is light in weight and unbreakable and lends itself to high speed
automatic filling operations.
Any ductile metal that can be worked cold is suitable for collapsible
tubes, but the most commonly used are tin, aluminium and lead. Tin is
most expensive and lead is cheapest.
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32. RUBBER:
Rubber is used mainly for the construction of closure meant for
vials, transfusion fluid bottles, dropping bottles and as washers in
many other types of product.
BUTYL RUBBER:
Advantages:
Permeability to water vapor .
Water absorption is very low.
They are relatively cheaper compared to other synthetic rubbers.
Disadvantages:
Slow decomposition takes place above 1300C.
Oil and solvent resistance is not very good.
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33. NITRILE RUBBER:
Advantages:
Oil resistant due to polar nitrile group.
Heat resistant.
Disadvantages:
Absorption of bactericide and leaching of extractives are considerable.
CHLOROPRENE RUBBERS:
Advantages:
Oil resistant.
heat stability is good.
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34. SILICON RUBBERS:
Advantages:
Heat resistance.
Extremely low absorption and permeability of water.
Excellent aging characteristic.
Disadvantages:
They are very expensive.
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35. TESTS FOR RUBBER/RUBBER CLOSURES
1.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
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36. 2.SELF SEALABILITY TEST FOR RUBBER CLOSURES
APPLICABLE TO MULTI DOSE CONTAINERS ONLY(IP
1996):
fill 10 vials with water to nominal volume and close the
vials with closures
pierce the cap and closures 10 times at different places
with no 21 syringe needle
immerse the vials in 0.1 %W/v solution of methylene
blue under reduced pressure
restore the nominal pressure and keep the container for
30 min and wash the vials
none of the vial should contain traces of colored
solution 36

37. TAMPER RESISTANT PACKAGING:
The requirement for tamper resistant packaging is now one of the
major considerations in the development of packaging for
pharmaceutical products.
Tamper resistant package is one having an indicator to entry in
which, if breached or missing, can reasonably be expected to provide
visible evidence to consumers that tampering has occurred.
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38. FDA approves the following configurations as tamper resistant
packaging:
1. Film wrappers
2. Blister package
3. Strip package
4. Bubble pack
5. Shrink seals and bands
6. FOil, paper, plastic pouches
7. Bottle seals
8. Tape seals
9. Breakable caps
10. Aerosol containers
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39. FDA REGULATIONS
 When the FDA evaluates a drug, the agency must be firmly
convinced that the package for a specific drug will preserve the
drug’s efficacy as well as its purity, identity, strength and quality
for its entire shelf life.
 The FDA does not approve containers as such, but only the
materials used in the container . A list of substances considered
``Generally Recognised As Safe’’ (GRAS) has been published
by the FDA.
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40. FDA Regulations for Tablets and Capsules
 Description: Overall general
description of container
closure system, plus:
For Each Packaging Component:
Name, product code, manufacturer.
Materials of construction.
Description of any addition treatments.
Suitability:
Protection: Light exposure .
Moisture permeation.
Seal integrity or leak tests for
unit-dose packaging.
Safety: (for each material of construction, as
appropriate)
 Chemical composition of all plastics,
elastomers, adhesives, etc.
 For tablets, capsules, and powders,
appropriate reference to the indirect food
additive regulation may be submitted.
 For rayon and cotton fillers, data from USP
monographs. For non-USP materials, data
acceptance criteria should be provided.
 For desiccants and other absorbent
materials: the size and shape should differ
from that of the dosage form.
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41. Description: Same as for tablets and capsules.
Suitability :Protection: Light exposure
Reactive gases(e.g., oxygen)
Solvent loss
Moisture permeation
Microbial contamination
Seal integrity or leak testing of tubes and
unit dose containers .
Safety: (for each material of composition, as
appropriate)
 Chemical composition of all plastics,
elastomers, adhesives, etc.
 For topical drug products (plastic
coatings for metal tubes), and plastic
drug delivery system components:
USP Containers testing.
 For topical delivery systems:
appropriate reference to indirect food
additive regulations.
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42. CONCLUSION :
Packaging is one of the most important part of pharmaceutical
industries .
Quality maintenance is major role played by packaging
material.
 Along with that it gives pharmaceutical elegance and
convenience to user to product.
 Many a times the packaging is may become a ideal unique
identification for some of brand in market.
Quality control of such important part is also a vary valuable
work .
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43. References:
 Leon Lachman , Herbert A. Liberman , The Theory & Practice Of Industrial
Pharmacy. Pg. 711-732
 Dean DA, Evans ER, Hall H. Pharmaceutical packaging technology
Pg:210-65.
 Remington. The Science and Practice of Pharmacy, Vol-1;Pg:1047-10 .
 Howard C. Ansell Loyd V. Allen, Pharmaceutical dosage forms, Pg. 67-91.
 N.k. Jain Pharmaceutical product development pg no 341-378
 Cooper and Gunn’s –dispensing for pharmaceutical students pg no13-22
 Michael E. Aulton the design and manufacturing of medicines no 626-639
 Copper and Gunn's tutorial pharmacy Materials of plant pharmaceutical
plant construction .Pg no
 R.M.MEHTA Packaging materials Pharmaceutics-I Pg no
 Indian Pharmacopiea,2007,Vol-1;Pg:599-25
 Encyclopedia of Packaging Technology",
 http://www.pharmaceutical-technology.com.
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