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The PACKAGING refers to all those activities related to designing,
evaluating and producing the container for a product. Simply,
PACKAGING is to store and protect product from any physical
damage and at the same time attracting the customer through
its appeal is called as PACKAGIGN.
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Keeping the contents clean, fresh, sterile and safe for the
intended shelf life is a primary function.
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Packaging is an integral part of pharmaceutical product
Protection
Against light
Against reactive gases
Against moisture
Against microbes
Against physical damage
Against pilferage and adulteration
Presentation
Identification
Information
Compatible
Convenience
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Primary Tertiary
Packaging Packaging
Secondary
Packaging
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Multidose /
Bulk
Re-closeables
Unit
Dose/Non-re-
closeables
Bottles Bottles
Aerosol packs Drums/Kegs
Tubes Sacks/Bags
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Glass Metal Plastic Rubber
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Glass
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Glass
Properties of Glass
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Glass
Advantages of Glass
Waseem Ahmed
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Glass
Types of Glass Except for type I glass containers, glass containers for pharmaceutical
preparation are not to be re-used.
Type I Glass Containers
It is highly resistant glass. for human blood and blood components
Laboratory must not be re-used.
glass apparatus.
Borosilicate glass / Neutral glass It has high melting point. Can be used to contain strong acids and alkalis.
(contains 80% silica, 10% boric oxide, It is more chemically inert than the soda lime glass. Suitable for parenteral or non-parenteral.
small amount of sodium oxide and Reduce leaching action.
aluminium oxide)
Type II Glass This is a modified type of Type III glass container with a high They are suitable for most acidic and neutral
Soda-lime-silica glass/ treated soda-lime hydrolytic resistance resulting from suitable treatment of the aqueous preparations whether parenteral or non-
glass/ De alkalized soda lime glass inner surface of a type III glass with sulphur. parenteral.
This is done to remove leachable oxides and thus prevents
blooming/weathering from bottles.
Type II glass has lower melting point when compared to Type
I glass and so easier to mould.
Type III Glass This is an untreated soda lime glass with average chemical They are used as packaging material for parenteral
Regular soda lime glass resistance. products or powders for parenteral use ONLY WHERE
It contains 75% silica, 15% sodium oxide, 10% calcium oxide, there is suitable stability test data indicating that Type
small amounts of aluminium oxide, magnesium oxide, and III glass is satisfactory.
potassium oxide. They used in packaging non-aqueous preparations and
Aluminium oxide impacts chemical durability while powders for parenteral use with the exception of
magnesium oxide reduces the temperature required during freeze-dried preparations
moulding. It is also used in packaging non-parenteral
preparations.
Type IV Glass This type of glass container has low hydrolytic resistance. It is used to store topical products and oral dosage
Type NP glass/General-purpose soda This type of glass containers are not used for products that forms
lime glass need to be autoclaved as it will increase erosion reaction rate
of the glass container.
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Glass
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Glass
Examples - Glass Pharmaceutical vials
Injection vials
Lyophilization vials
Tablet vials
Large OD vials
Special vials
Two-compartment vials
Sampler vials
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Plastic
A plastic is a material that contains an essential ingredient one or more polymeric organic substances of
large molecular weight.
Plastic containers for pharmaceutical products are primarily made from the following polymers:
polyethylene, polypropylene, polyvinyl chloride, polystyrene, and to a lesser extent, polymethyl
methacrylate, polyethylene terephthalate, polytrifluoroethylene, the amino formaldehydes, and
polyamides.
Plastic containers consist of one or more polymers together with certain additives.
The amount and nature of the additives are determined by the nature of the polymer, the process used to
convert the plastic into the containers, and the service expected from the container.
For plastic containers in general, additives may consist of antioxidants, antistatic agents, colours, impact
modifiers, lubricants, plasticizers, and stabilizers.
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Plastic
Properties of Glass Disadvantages of Glass
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Plastic
Chemical Structure Orientation
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Plastic
Drug Plastic Considerations
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Plastic
Important problems
Sorption
This process involves the removable of constituents from the drug product by the
packaging material. This may effect on the therapeutic efficacy of the drug. Sorption may
change the chemical
Desorption (leaching)
Problems with the colouring agents used in plastic, these may leach into
the drug.
Permeation
Transmission of gases, vapours or liquids through packaging material to the drug that cause
oxidation or hydrolysis of the drug. This condition may worst with increase in temperature and
humidity.
Photo Degradation
Some ingredients of plastic may react chemically with the drug or vice versa and
change the appearance of the drug.
Polymer Modification
The physical or chemical alteration of the packaging material by the drug is called
modification.
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Plastic
Forms of Plastic
Amorphous Plastic Crystalline Plastic
They give good transparency. They are opaque in nature.
Hard but posses little brittleness. They are more flexible.
More permeable to gases and vapour. They are less permeable to gases and vapour.
Less inert. More Inert.
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Plastic
Types of Plastic
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Plastic
Plastic used for Pharmaceutical Products are primarily made form
the following polymers
Polyethylene
Polypropylene
Poly Vinyl Chloride
Poly vinylidene chloride (PVdC)
Polystyrene
Polymethyl Methacrylate
Amino Formaldehyde
Poly Carbonate
Ionomer
Polymonochlorotrifluoroethylene
(PCTFE)
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Plastic
Polyethylene
1. Low density polyethylene (LDPE) – branched
chain
2. High density polyethylene (HDPE) – linear
chain
High density Characteristics: Advantages: Disadvantage:
polyethylene
(HDPE) Low cost Low cost Poor barrier for oxygen
Moderately flexible Good moisture barrier and other gases
Stiffer and has better barrier properties Not attack by most Orders and flavours are
Chemical resistant solvent sometime lost
Poor clarity Perfume or flavouring oil
Translucent in natural start and can be tinted can transpire rapidly
with any opaque colour Stress-crack in the
Odourless and tasteless presence of some
products
Applications:
Polyethylene
1. Low density polyethylene (LDPE) – branched
chain
2. High density polyethylene (HDPE) – linear
chain
Low density Characteristics: Advantages: Disadvantage:
polyethylene
(LDPE) Odourless and tasteless Low cost Prone to stress cracking in
Easily blended with copolymers. Flexible the presence of
Highly resistant to most solvents Light weight surfactants, vegetable or
Poor barrier for gases Moisture barrier mineral oils.
Softening temperature is around 110 – 150 oC Tough May have problem with
Easily pigmented Chemical resistant flavour or odors.
Good Transparency Heat sealable
Translucent
Applications:
Polypropylene (PP)
Characteristics:
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Plastic
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Plastic
Polystyrene (PS)
Characteristics:
It is used for jars ointments and cream with low water content.
Also used to manufacture syringes.
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Plastic
Polycarbonates
Characteristics:
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Plastic
Ionomer
Characteristics:
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Plastic
Polymonochlorotrifluoroethylene (PCTFE)
Characteristics:
Laminated PCTFE (Aclar)/PVC sheet is used widely in thermoformed blister pack for
moisture-sensitive solid dosage form.
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Plastic
Advantages of Plastic
Disadvantages of Plastic
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Rubber
Rubber is used mainly to manufacture closures for vials, transfusion fluid bottles, dropping
bottles and washer in many other types of products.
NATURAL Rubber – suitable for closures for injectable products as rubber reseal after multiple
insertion of needle.
SYNTHETIC Rubber – have fever additives and thus fewer extractable and tends to experience
less sorption of product ingredients. Not suitable for repeated insertion of needle because it
fragment or pushing small particles of the rubber into the product.
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Rubber
Types of Rubber
Butyl Nitrile Neoprene Silicone
These are copolymers of These are polymers of 1:4
isobutylene with 1-3% of chloprene
isoprene or butadiene
Advantages Resistant to aging and Oil resistant due to Resistant to oxidation Heat resistant up to
chemical attack polar nitrile group hence these rubbers 250 oC
Very low permeability Heat resistant age well Extremely low
to water vapours and Oil resistant absorption and
air Heat stability is up to permeability of water
Low water absorption 150 oC Excellent aging
Cheaper compared to Less water absorption
other synthetic and permeable than
rubbers. natural rubbers
Disadvantages Decomposition takes Absorption of Poor tensile strength
place above 130 oC bactericide and Expensive
Oil and solvent leaching of extractives
resistance is not very are considerable
good
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Metal
Metals have been the base of packaging industry since a long time. Different type and varieties of
metals are used in the packaging.
In packaging the metals used in general are Aluminium, Tin, Lead and Stainless steel.
Metals have the highest temperature tolerance, highest physical strength, most durability, excellent
light, gas and moisture barrier, and stiffness. Some forms of metal packaging also have significant
operational advantages. For example, metal cans can be produced and filled at higher speeds than
glass or plastic bottles.
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Metal
Advantages of Metal
Disadvantages of Metal
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Metal
Aluminum
Lead
Tin
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Metal
Aluminum
Characteristics:
Aluminum is used in several products in the packaging industry, such as tubes & foils, aluminum
containers, bottles & cans, caps & closures, lidding materials, casseroles, etc.
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Metal
Examples - Aluminum
Tubes
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Metal
Lead
Characteristics:
Applications:
With lining lead tubes are used for such product as fluoride toothpaste.
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Metal
Tin
Characteristics:
Tin-free steel are generally used for screw & lug caps, tops, snap & press on closures and
shallow drawn food cans.
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What could I have left out?
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Thankyou
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