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 ml 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of a dose Antibiotic vial vehicle is added to dissolve the powder Multiple dose provide flexibility in the dose to be withdrawn Greater risk of contamination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 Multiple doseSingle dose Allow variations in dose withdrawnDifficult to manipulate Rubber- preservative loss/ particulate contamination Closures -air-tight Indrawing of air may lead to contamination of unused product Essential for packaging of drugs under Nitrogen 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