Title 12. STERILIZATION METHODS FOR ALL PHARMACEUTICAL PRODUCTS.pdf ✅

PHARMD GURU Page 1 STERILIZATION METHODS FOR PHARMACEUTICAL PRODUCTS: Sterile products are the products subjected to sterilization with no micro organisms in it. Examples include parenterals, dressings, sutures, materials or instruments used during surgery, ophthalmic products, irrigation fluids used for irrigating tissues, dusting powders, ointments and creams, dialysis solutions, implants, culture media, filters, air, fermentation vessel and media and equipments. All these are categorized under two categories. Products that are sterilized in the final container is called terminal sterilization (autoclave and gamma radiation sterilization) and the other is aseptic processing, where sterilization is required separately for the product, closure, container and other articles. The commonly used sterilizations are dry heat and moist heat, radiation and filtration sterilization, and others like UV. The moist heat comes under terminal sterilization, and filtration comes under aseptic processing. The moist heat sterilization is not suitable for non aqueous preparations, and dry heat is used for products that can withstand high temperatures (glass articles).  Ethylene oxide sterilization is done for heat labile products which cannot withstand heat sterilization and filtration is used for bulk liquids and gases.  Injections or parenterals, aqueous solutions in small quantity which can withstand high temperature can be filled into vials or ampoules, which are then subjected to terminal sterilization by autoclaving.  Oily Injections, small volume are subjected to dry heat sterilization.  Suspensions (both aqueous and oily suspensions) are subjected to terminal sterilization.  IV fluids of high volume can be sterilized by using autoclave or by terminal sterilization or by filtering.  TPN (total protein nutrition) by aseptic processing.  Closures are sterilized by radiation sterilization.  BFS (blow filled sealed containers) used for vaccines, anaesthetics etc which involves multi step processes are sealed aseptically. STERILIZATION METHODS FOR ALL PHARMACEUTICAL PRODUCTS
PHARMD GURU Page 2  Non injectables like irrigation fluids, dialysis fluids are needed to be sterilized by an autoclave.  Ophthalmic preparations are sterilized by aseptic processes.  Dressings containing cellulose are sterilized by autoclaving, if it withstands the temperature.  Wax containing materials has to be sterilized by dry heat sterilization.  Implants present in small cylinders, which contain some hormones and polymers withstanding the temperature are sterilized by autoclaving and dry heat sterilization.  Sutures and ligatures, in case of absorbable sutures, are sterilized by terminal sterilization using gamma radiation.  Non absorbable sutures are sterilized by autoclaving.
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