Packaging
PACKAGING
Packaging is the science and art of enclosing or
protecting products for distribution, storage, sale
and use.
Packaging also refers to the process of design,
evaluation and production of packages.
Packaging may also be defined as the collection of
different components (e.g. bottle, vial, closure, cap,
ampoule, blister) which surround the pharmaceutical
product from the time of production until its use.
PACKAGIN
G
Packaging has been defined as the
means for providing :-
• Presentation
• Identification
• Protection
• Convenience
• Containment during storage
4 SELECTION OF PACKAGING
MATERIAL
Factors need to consider. . .
•The product or pack contents
•The application of the product
•Content stability, and the need of protection form any
factor (Air, water, shock, vibration, compression)
•Content reactivity ( with relevant to the packaging
material)
•Acceptability of the pack to the consumer or user
•Regulatory, legal and quality issues
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PROPERTIES OF PACKAGING MATERIAL:
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The material selected must have the following
characteristics:
•Must meet tamper-resistance requirements
•Must be legally approved
•Must be non-toxic
•Must not impart odor/taste to the product
•Must not react with the product
•They must protect the product from environmental
conditions/effects
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TYPES OF PACKAGING
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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: Ampoules,Vials ,Containers ,Dosing
dropper ,Closures
(plastic, metal) ,Syringe ,Strip package, Blister packaging.
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Secondary packaging is outside the primary packaging –
7 used to group primary packages together.
Example: Paper and boards, Cartons, fibers, Box
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8 Tertiary packaging is used for bulk handling, warehouse
storage and transport shipping. The most common form is a
palletized unit load that packs tightly into containers.
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Apart from primary and secondary packaging, two types of
special packaging are currently in use, as follows:
9 •Unit-dose packaging. This packaging guarantees. .
-Safer medication
-Reducing medication errors
-Easy for patients
•Device packaging. Packaging with the aid of an
administration device is user-friendly
Easy administration i.e. prefilled syringes, droppers,
transdermal delivery systems, pumps and aerosol sprays.
Administer correct and the right amount
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10 TYPES OF PACKAGING MATERIAL
I) Glass
II) Metals
III) Rubbers
IV) Plastics
V) Fibrous material
VI) Films, Foils and laminates
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GLASS:
Glass has been widely used as a drug packaging material.
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Glass is composed of sand, soda ash, limestone & cullet.
ADVANTAGES
• They are hygienic and suitable for sterilization
• They are relatively non reactive
• It can accept a variety of closures
• They can be used on high speed packaging lines
• They have good protection power.
• They can be easily labeled.
DISADVANTAGES
• It is relatively heavy
• Glass is fragile so easily broken.
• Release alkali to aqueous preparation
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GLASS:
Glass has een widely used as a drug packaging
b material.
Glass is mposed of sand, sh, limestone,&
co cullet. soda a
Si, Al, Na, erally used
K, Ca, Mg, Zn & into
preparation of Ba are gen glass
ADVANTAGES
• They are hygie ion
• They are relat nic and suitable for sterilizatg on the grade
chosen) ively non reactive
• They can be used on high speed packaging lines
( dependin
• They can be easily labeled.
• They are transparent.
• They are available in various shapes and sizes.
• They can withstand the variation in temperature and
pressure during sterilization.
• They are economical and easily available.
• They can protect the photosensitive medicaments from light
during their storage.
• They are neutral after proper treatment.
• They are impermeable to atmospheric gases and moisture.
• They have good protection power.
• They do not deteriorate with age.
• They can be sealed hermetically or by removable closures.
D ISADVANTAGES
• It is relatively heavy
• Glass is fragile so easily broken.
• Release alkali to aqueous preparation.
• They may crack when subjected to sudden
changesof temperature.
• Some containers can impart alkalinity and insoluble
flakes to the formulations.
Flaking
• During flaking the alkali is extracted from the surface of
the glass containers and a silica rich layer is formed
which sometimes gets detached from the surface and
can be seen in the contents in the form of
shining flakes.
Weatherin
g
Weathering is a common problem with glass
containers in which sometimes moisture
condensed on the surface of glass
container, can extract some weakly
bonded alkali, leaving behind a white
Tdeposit
YPES OFof alkali
GLAScarbonate.
S:
• Type I ( Neutral or Borosilicate Glass)
• Type II ( Treated Soda-lime glass)
• Type III ( Soda-lime glass)
• NP—soda glass (non parenteral usage)
• Colored glass
MINIMUM QUALITY
TYPE OF FORMULATION CAN BE
OF GLASS THAT CAN
PACKAGE TYPE PACKED
BE USED
Aqueous Injectables Of Any pH Type I
Aqueous Injectables Of pH Less Than 7
Ampoule Type II
Non-Aqueous Injectables Type III
Aqueous Injectables Of Any pH
Type I
Aqueous Injectables Of pH Less Than 7
Type II
Vial Non-Aqueous Injectables Type III
Dry Powders For Parenteral Use (Need To
Be Reconstituted Before Use) Type IV
MINIMUM
TYPE OF FORMULATION CAN BE PACKED
QUALITY OF
PACKAGE GLASS THAT
TYPE CAN BE USED
Tablets, Capsules, Oral Solids & Other Solids For
Reconstitution Type IV
Oral Liquids (Solutions, Suspensions, Emulsions)
Type IV
Nasal & Ear Drops Type IV
Bottle
s and Certain Types Of External Semisolids
(Rubeficients, Local Irritants) Type IV
Jars
Blood & Related Products Type I
Auxiliary Packaging Device With Certain Kind Of
Dropper Products
Type IV
Aerosol product ( solution, suspension, emulsion or
Aerosol semisolid type)
container Type I
METALS
Metal containers are used solely for medicinal products for
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non-parenteral administration.
Metal is strong, opaque, impermeable to moisture, gases,
odors, light, bacteria,
it is the ideal packaging material for pressurized containers.
It is resistant to high and low temperatures
They include tubes, packs made from foil or blisters, cans,
aerosol and gas cylinders.
ALUMINIUM
• It is relatively light
• Inert and resistant
• Barrier to light and chemicals
• Impermeable and easy to work into a variety of formats.
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ALUMINIUM
• It is used for aerosol cans and tubes for effervescent tablets,
19 collapsible tubes for semi solid preparations or roll on screw
caps, laminated packaging material.
Disadvantages
• Major disadvantage is its reactivity in raw state,
• liable to corrosion ( when exposed to some liquids and semi
solid formulations, particularly at extreme pH or if the
product contains electrolytes.
To overcome this problem, Aluminium is lined with epoxide,
vinyl or phenolic resins.
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RUBBERS
• Used to form closures such as bungs for vials or in similar
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applications such as gaskets in aerosol cans.
• Used in multiple use closures for injectable products as
rubber reseals after multiple insertion of needle.
• Disadvantages are;
i. It doesn't well tolerate multiple autoclaving becoming
brittle and leads to relative degree of extractable
material in presence of additives.
ii. Risk of product absorbing on or in to a rubber.
iii. It has certain degree of moisture & gas permeation.
2) Synthetic rubber:
• Experience less sorption of product ingredients.
• Are less suitable for repeated insertions of needle
• E.g. Silicone, butyl, bromobutyl, chlorobutyl etc.
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PLASTICS
21 Thermoplastic
Capable of being shaped after initial heating and solidifying
by cooling.
Resistant to reaction, heat, breakage
Moldable into desired shapes
E.g. Polystyrene, polyethylene and polyvinyl chloride.
Thermosets
They have permanent crosslinking
Solid and no softening.
E.g. Phenolic, urea and melamine
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Used for;
rigid bottles for tablets and capsules, squeezable bottles for
22 eye drops and nasal sprays, jars, flexible tubes and strip and
blister packs.
Advantages
• Least expensive than glasses
• Ease of transportation
• No risk of breakage
• Flexible
• Light in weight
Disadvantages
• They are not as chemically inert as glass.
• They are not as impermeable to gas and vapour as glass.
• They may possess an electrostatic charge which will attract
particles.
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EXAMPLES OF PLASTICS
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Plastic bottles made from PP, HDPE and Plastic pouches of HDPE Bottle- PET and spray- PP
PS
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FIBROUS MATERIALS
Fibrous materials include: Papers, Labels, Cartons, Bags,
24 Outers, Trays For Shrink Wraps, Layer Boards On Pallets,
etc.
The Applications as well as 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.
for bulk shipments.
Corrugated Fiber board
Paper
FILMS, FOILS & LAMINATES
• Regenerated cellulose film, cellulose coatings, foil and paper
play different roles such as supportive, barrier, heat seal &
decorative.
• For Example:
• Aluminum foil offers the best barrier properties than most
impermeable plastics.
• Uses of films, foils, laminations:
Strip packs
Blister packs
Sachets
25 Diaphragm seals for bottles
Liners for boxes either attached or loose bag-in-box
systems & bags.
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is the best pharmaceutical packaging film for
Alu-alu foil
tablets, capsules, which is taking place of PVC film.
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Characteristics:
Applicable to tablets, capsules, pills, etc.
It's a good substitute for PVC sheet.
No cracking, delamination or pinholes
It has the quite good blocking properties effectively
protecting drugs from water vapor, oxygen and ultraviolet.
It is particularly suitable for packing moisture-sensitive
drugs
It is shaped easily by changing the mold.
Attractive appearance can upgrade drug's image
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BLISTER PACK
Blister packs are for pharmaceutical tablets, capsules or lozenges
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Consist of two principal components : 1) cavity inside which
the product fits and 2) the lidding foil of the pack.
Working: a plastic film or sheet is unwound from the reel and
guided though a pre-heating station on the blister line
The temperature of the pre-heating plates (upper and lower
plates) is such that the plastic will soften and become
moldable.
Then aluminum foil is sealed on plastic and cut into desired
shape blister pack
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STRIP PACKING
A strip is formed by feeding two sheet of a heat sealable
28 flexible film through a heated crimping roller.
The product is dropped into the pocket formed before forming
the final set of seals.
A continuous strip of packets is formed which is cut to the
desired number of packets in length.
The materials used for strip package are cellophane, polyester,
polyethylene, polypropylene, polyvinylchloride.
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CLOSURES
Closures are the devices by means of which containers can be opened
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and closed. Proper closing of the container is necessary because
It prevents loss of material by spilling or volatilization.
It avoids contamination of the product from dirt, microorganisms or
insects.
It prevents deterioration of the product from the effect of the
environment such as moisture , oxygen or carbon dioxide.
Material used for closures are;
Cork
Glass
Plastic
Metal
Rubber01/23/2025
SYMBOLS USED ON PACKAGES AND LABELS
30 Many types of symbols for package labeling are
nationally and internationally standardized. For product
certifications, trademarks, proof of purchase, etc.
identification code .
Fragile This way up Keep away from Keep away from
sunlight water
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Tests of packaging materials
31 Tests
Quality control tests are following:
— visual inspection (cleanliness, defects)
—Environmental Test (Water absorption, light transmission etc)
— Mechanical tests (tensile strength, Creasing)
— chemical tests (glass alkalinity, plastic chemical test)
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USES OF PACKAGING:
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•Physical protection: mechanical shock, vibration, electrostatic
discharge, compression, temperature etc.
•Information transmission: Packages and labels communicate
how to use, transport, recycle, or dispose of the package or
product.
•Marketing: The packaging and labels can be used by marketers
to encourage potential buyers to purchase the product.
•Convenience: Packages can have features that add convenience
in distribution, handling, stacking, display, sale, opening, re-
closing, use, dispensing, reuse, recycling and ease of disposal.
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•Barrier protection: A barrier from oxygen, water vapor,
dust, etc., is often required. Permeation is a critical factor in
design. Keeping the contents clean, fresh, sterile and safe for
the intended shelf life is a primary function.
•Security: Packaging can play an important role in reducing
the security risks of shipment.
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