Transcript Packaging of injections

Packaging of injections
Containers for injection
ideal properties
• Does not affect its contents
• No surface changes at temp. & pressure
associated with sterilization
• Should protect from light when the contents
are photosensitive
• Container should be cheap enough to dispose
after one use or be easy to clean & reuse
• Contents should be easy to examine through
the container to detect particles,
contamination & decomposition
Types of containers
• Ampoules: single-dose glass containers with
capacity of 0.5-50ml
• Made from neutral or soda glass
• Liberate gas particles on opening
• Sealed by heat fusion to exclude MO
• Used for solutions or powders
• Cartridges: cylindrical glass tubes sealed by
rubber at each end
• Holding slightly more than 1 ml
• They are inserted into a metal syringe barrel
• Used once
• Prepacked syringes: contain one dose of
medication
• No danger of particulate contamination due to
glass
• Antibiotic vials & multiple-dose containers:
• Rubber capped & allow withdrawal of a dose
• Antibiotic vial vehicle is added to dissolve the
powder
• Multiple dose provide flexibility in the dose to
be withdrawn
• Greater risk of contamination
• Large volume fluids
• Plastic or glass
• Glass: thick walled & sealed with materials
other than glass ( plastic, rubber with AL
screw cap)
• Plastic: unbreakable, light & disposable less
transparent than glass, easily punctured,
difficulty in estimating unused vol.
Single dose vs. multiple dose
Single dose
Multiple dose
Difficult to manipulate
Allow variations in dose withdrawn
Closures -air-tight
Rubber- preservative loss/ particulate
contamination
Essential for packaging of drugs under
Nitrogen
Indrawing of air may lead to
contamination of unused product
No possibility of solvent loss
Sterilization of injections
• If possible, Injections should be sterilized in
their final containers to reduce to a minimum
the possibility of contamination
Dry heat sterilization
• Used for oily injections
• Progesterone injection BP
• Proyliodone injection BP is thermolabile so it
is prepared by addition of the serile powder
by aseptic techniques to arachis oil previously
sterilized by dry heat
Moist heat sterilization
• Autoclaving is used for thermostable aq.
Preparations
• Closures may be sterilized by autoclaving
them in solutions containing preservatives ( &
medicaments) at concentarions twice those
found in the injection
Heating with a bactericide
• For injections that are thermolabile to
autoclaving
• Not used for all routes
Sterilization by filtration
• Alternative to dry heat for oils
• May avoid slight changes in heat sterilized
products
• Suitable for thermolabile stable aq.
Preparations
• Certain drugs may adsorb to filter
• Reconstitution by aseptic process at time of
injection
• Terminal sterilization with gaseous
disinfectants may be used provided no
chemical changes will happen in the drug
• Ex. Erythromycin unharmed by this process