Vial filling and terminal sterilisation for drug in pharmacology FDA Essay

Vial filling and terminal sterilisation for drug in pharmacology FDA - Essay Example The main sterilization processes relate to terminal sterilization and aseptic filing process which incorporates the vial filling and syringe filling. The Closed Vial Filling System (CVFS) is composed of containers that are sterile and closed and are filled through their stoppers, then resealed again immediately to avoid entry of bacteria. The main characteristics of the process relate to a surrounding environment of ISO 8 minimum operation, an enclosure system, sanitization and prevention of material entry. The enclosure system includes a rig was to separate the operation from operators, HEPA-filtered air flow supplied from the ceiling with air exit, locked doors, with alarms, glove ports for area access entry of product to be filled and through aseptic connector. The entry of material is through closed vials that have been pre-sterilized by gamma rays, through rapid transfer ports (RTP) and through VHP airlock using PE wrapped vial. Entry can also be through caps which are sterilized earlier and a fluid path sterilized by gamma rays. Sanitation is through disinfection of all contact places, bags for fluid path and within the vials using an agent with spores. High quality and design are observed in the terminal sterilization