Vial filling and terminal sterilisation for drug in pharmacology FDA - Essay Example

Topic The current sterilization process for drug application has been in question for a long period. The provisions for Food and Drug Administration on the sterilization process validity and documentation represents the thinking of the process of drug application. The efficiency of a sterilization process depends on the series of protocols, scientific experiments and demonstrations that show that associated procedures of control are right and can produce a sterile product. The results, conclusion, method and procedure determine whether the process of sterilization is valid.

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 processReferenceShayne,S,(2008), Pharmaceutical Manufacturing Handbook: Production and Processes (Pharmaceutical Development Series)