This document discusses pharmaceutical packaging. It defines pharmaceutical packaging and describes the primary and secondary/tertiary packaging systems. The key requirements for pharmaceutical packaging are to protect the product, be non-reactive, prevent contamination, and be FDA approved. Important criteria for selecting packaging materials include stability, compatibility with contents, strength, moisture protection, and cost. Common packaging materials include glass, plastic, metal, paper, rubber, and closures. Guidelines for quality control of packaging materials require containers and closures to meet pharmacopeial standards and be properly washed and sterilized.

1. s
BY,
PRAVADA NAMDEO PATIL
ROLLNO.– 022
GUIDED BY: DR. SHRUTIKA D. PATIL MAM
QUALITYASSURANCETECHNIQUE,2019-2020
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2. DEFINITION
 Packing: Packing consists of enclosing an individual
item, or several items, in a container, usually for
shipment or delivery.
 Pharmaceutical Packaging: Pharmaceutical
packaging means the combination of components
necessary to contain, preserve, protect & deliver a
safe, efficacious drug product, such that at any time
point before expiration date of the drug product, a
safe & efficacious dosage form is available.
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3. TYPES OF PACKAGING SYSTEMS
 Primary package system: Made up of those
package components & sub components that come
into direct contact with the product, or those that
may have a direct effect on the product shelf life.
 Secondary or tertiary package system: Includes
cartons, corrugated shippers & pallets.
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4. PACKAGING MUST MEET THE FOLLOWING
REQUIREMENTS
 Protect the preparation from environmental
conditions.
 Non-reactive with the product and so does not alter
the identity of the product.
 Does not impart taste or odour to the product
 Nontoxic
 FDA approved
 Protect the dosage form from damage or breakage
 Meet tamper-resistance requirements, wherever
applicable. 4

5. CRITERIA FOR SELECTION OF PACKAGE
TYPE AND PACKAGE MATERIAL
• Stability .
• Compatibility with the contents .
• Strength of container and the degree of protection
required.
• Moisture- proofness .
• Resistance to corrosion by Acids or Alkalis.
• Resistance to grease ,microorganism, insects,
rodents and the difference in the temperature.
• Protection against salt.
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6. • Protection against light, fire
• Cost
• Machine suitability of packaging and the filling
method
• Convenience of the packaging for the physician,
pharmacist and finally the patient.
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7. PACKAGING MATERIALS & CLOSURES
 Glass
 Plastic
 Metals
 Paper and Board
 Rubber
 Cotton
 Adhesive and inks
 Closures
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8. GLASS
 Advantages:
 Superior protective qualities
 Economical
 Readily available in a wide variety of sizes & shapes
 Essentially chemically inert, impermeable, strong and
rigid
 Has FDA clearance
 Does not deteriorate with age
 Provides an excellent barrier against every element
except light with a proper closure system. Coloured
glass, especially amber, can give protection against
light. 8

9.  Disadvantages:
 Fragility (easily broken).
 Heavy Weight.
 Composition of glass:
Mainly made up of
 Sand – pure silica
 Soda-ash – sodium carbonate
 Limestone – calcium carbonate
 Cullet – broken glass that is mixed with the batch &
acts as a fusion agent for the entire mixture.
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10. TYPES OF GLASS CONTAINERS
 Type-I Borosilicate Glass
 Type-II Treated Soda Lime Glass
 Type-III Regular Soda Lime Glass
 Type-NP General Purpose Soda Lime Glass
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11. TYPE-I BOROSILICATE GLASS
 This is highly resistant glass, a part of the alkali and
each cations are replaced by Boron or Aluminum &
Zinc.
 It is more chemically inert than soda lime glass.
 The addition of approx 6% boron to form type I
glass to reduces the leaching action.
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12. TYPE-II SODA LIME GLASS
 Type-II container is made up of commercial soda lime glass
that has been de-alkalized or treated to remove surface
alkali.
 The de-alkalizing process is known as Sulfur treatment.
 This prevents weathering of bottles(When glass is stored
for several time with extreme temperature the wetting of
surface takes place then salts of glass dissolved out this
called as ‘weathering’ )
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13. SULPHUR TREATMENT
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Glass is exposed to atmosphere containing vapour and acidic gases of sulphur dioxide
at elevated temperature
Which result in the reaction between glass and surface alkali
Alkali is removed from the glass
When the container are washed before filling
Sulphur dioxide treatment neutralizes alkali oxide on the surface of glass
Which makes glass chemically more resistant

14. TYPE-III REGULAR SODA LIME GLASS
 Containers are untreated & made up of commercial
soda lime glass of average & better than average
chemical resistance.
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15. TYPE-NP GENERAL PURPOSE SODA
LIME GLASS
 Containers are made up of soda lime glass are
supplied for non- parentral products, those
intended for oral or topical use.
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16. PLASTIC
 Advantages:
 Ease of manufacturing
 Available in various types of quality
 Freedom of design to which they lend themselves
 Extremely resistant to breakage
 COMMONLY USED POLYMERS:
• Polyethylene Polypropylene
• Polyvinyl chloride (PVC)
• Poly tri-fluoro ethylene
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17.  LESS COMMONLY USED POLYMERS:
• Polymethyl methacrylate
• Polyethylene terephthalate
• Polystyrene Amino formaldehydes
• Polyamides
 Limitations of Plastic Materials:
• Permeation
• Leaching
• Sorption
• Chemical modification
• Alteration on the properties of plastics or product
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18. TYPES OF PLASTIC CONTAINER
 Thermosetting Type :-
• It is used in packing industry for bottles & closures.
• These are usually hard & brittle at room
temperature & cannot be remelt without
decomposition.
• The main types are Formaldehyde & Urea
formaldehyde resins.
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19.  Thermoplastic Type :-
• It includes material which can be converted into an
unlimited range of shapes & sizes.
• This type of plastic can be remelted without
decomposition.
• The commonly used materials are low density
polythene, high density polythene, polyvinyl
chloride, Poly methyl meth-acrylate (PMMA),
polystyrene polyamide (Nylon), polypropylene,
polytetra-fluoroethylene (PTFE).
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20. METAL
 Aluminium & stainless steel are the metals of choice
for both primary & secondary pharmaceutical
packaging.
 Form excellent tamper-evident containers.
 Metals are strong, impermeable to gases so they
are ideal packaging material for pressurized
containers.
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21. PAPER AND BOARD
 The paper-based materials are the important part
of pharmaceutical packaging.
 Paper-based materials include: Labels, Cartons,
Bags, Outers, Trays For Shrink Wraps, Layer Boards
On Pallets, etc.
 The Advantages of Cartons include: -
• Increases display area
• Provides better stacking for display of stock items -
Assembles leaflets
• Provides physical protection especially to items like
metal collapsible tubes.
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22. RUBBER
 Mostly used to make stoppers and bulbs for
dropper assemblies.
 Examples of rubber for pharmaceutical products
include:
1. Natural rubber
2. Neoprene rubber
3. Nitrile rubber
4. Butyl rubber
5. Chlorobutyl rubber
6. Bromobutyl rubber
7. Silicone rubber 22

23. CLOSURES
 Depending upon the type of container, closures
may have different shapes & sizes.
 Special design of stopper may also be required
for some pharmaceutical production processes
such as lyophilization.
 Closures, which form a part of the primary
packaging system, are very important & should
be therefore carefully selected. They form
essential component of the container & an
integral part of the drug preparation.
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24. TYPES OF CLOSURES
The basic types of caps and closures include:
 Thread Screw : This provides physical and chemical barrier to the
contents in the container. They are either made of plastic or made
of metal.
 Lug Cap: This differs from the thread screw closure due to the
presence of continuous thread on the container. It is more
commonly used in food industries rather than pharmaceutical
industry.
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25.  Crown Cap : It is a crimped closure more commonly used in
beverage industry.
 Rubber Closures: Rubber consists of several ingredients
one of which is an elastomer. Rubber compounds used in
pharmaceutical packaging contain only limit number of
ingredients which are difficult to extract. These closures do
not pose any problem and can be used in contact with a
large number of drug preparations.
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26.  Roll on Closure Pilfer proof: resealable and non resealable
type of roll on closures are available. These are dimension
specific. Roll on closure hence require an easy to mould
material such as aluminium.
 Pilfer Proof Closure :This differs from standard roll on
closure in that it has a longer skirt length. When this
closure breaks at the bridge, the bank remains at the neck
of the container.
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27.  Tamper – Evident Closures : Tamper evident
closures are designed to prevent accident and
intentional tampering to create safe packaging. The
main concept of the tamper- evident packaging is
increasingly being recognized in pharmacopoeias.
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28. WHO GUIDELINES FOR QUALITY
CONTROL OF PACKAGING MATERIALS :
 All the containers and closures anticipated for use
should fulfill the pharmacopoeial indicated
requirements.
 All the containers and closure should be washed before
sterilization with water for injection according to the
procedure.
 The design of the closures, containers and stoppers
should have an airtight seal when fitted to the bottles.
 When the glass containers are used, the composed
calendar of purging might be set down and followed.
 Containers of parenteral and ophthalmic preparation
should be scrutinized against dark or white background
to guarantee freedom from impurities 28

29. REFERENCE
 Book of Packaging of Pharmaceutical and Healthcare by Paine and
Lokhard.
 Handbook of Pharmaceutical Packaging by Edward and J Bauer
 Book of Pharmaceutical Packaging and Technology by Evans and
Hall.
 file:///G:/presentations/pics/FeaturesfunctionsandselectionofPharmaceutic
alpackaging.pdf
 file:///G:/presentations/pics/hitesh-
pharmaceutical_packaging_component_and_evaluation.pdf
 file:///G:/presentations/pics/packagingevaluation.pdf
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