Packaging.

1. Packaging
Definition
the process by which the pharmaceuticals are suitably packed
they should retain their therapeutic effectiveness from the
time of their packaging till they are consumed
art and science of enclosing products
It involves preparing the articles for transport, storage, display and use
a bridge connecting the production with the marketing
functions
(objectives)
Physical protection
Barrier protection
Convenience
Containment
Security
Information communication Marketing
all external influences that can alter the properties of the product.
biological contamination.
physical damage.
Carry the correct information and identification of the product.
Allow Security
Tamper evident/ child resistance.
Anti counterfeiting
Protect against
Levels of
packaging
Primary
the material that first envelops the product and hold it.
It is usually the smallest unit of distribution.
direct contact with the contents
Secondary
outside the primary packaging
used to group primary packages together
Tertiary used for bulk handling, warehouse storage and transport shipping
Closures
Materials
used
Cork
Glass
Plastic
Metal
Rubber
Disadvantages
Mold growth when used for aqueous preparation.
May shed particles to products.
Advantages
Inert
Don't impart undesirable odor or flavor to the
preparation
They are an ideal materials for making the stoppers
their use is restricted to laboratory glass apparatus as they can
slip out of neck of the containers easily during transport and
handling
Advantages
Advantages
Disadvantages
Disadvantages
Unbreakable
Light in weigh
Easily moulded into various shapes and sizes
Plastic closures selected must be tested before use due
to
Leaching
Adsorption
Chemical reaction
Tin plated and aluminum closures are most widely used.
mainly used for
vials
multi-dose containers
I/V fluid bottles
because of its self sealing
properties
Advantages
Good quality
not deteriorate with age
resistant to sterilization conditions
Self seal
Although porous, they are non permeable as they
do not allow the transfer of water vapors or
gases.
Unbreakable
tough
can be easily transported.
Disadvantages
The manufacture process is complicated.
Rubbers need
especial
treatment to prevent
absorption of the parenteral solution.
Leaching of one or more constituents of the
rubber.
Closures liners
Materials that are placed in a closure to
provide an effective fitting between the
closure & the neck of the container to
prevent
leakage of the product.
decomposition of the product due to
microbial contamination.
moisture and gas penetration
Closures and packaging
specifications
should protect the product and provide air tight closing to the container (Closure liners)
should not react with the product
should not migrate any additive to the preparation
should withstand the sterilization temperature if terminal sterilization.
Can be adapted to high speed packaging machines and equipment.