CLEANROOM VALIDATION PROCESS
Whether using sterilization methods such as moist heat, dry heat, gamma or electron radiation, filtration, UV, hydrogen peroxide, etc., a validation study must follow established procedures. It requires looking at sterility assurance level (SAL) or the probability a single unit that has been sterilized in fact remains nonsterile. There’s never a 0% chance a microorganism hasn’t survived, and one can’t prove all of them have been eliminated.
In general, a sterilization process must deliver an SAL of one in a million.
Prudential Cleanroom Services provides Rx compounding companies compliant cleanroom gowning systems that are required for USP 797. PCS specializes in cleanroom garment processing services for aseptic, particulate & ESD controlled environments. All PCS Cleanroom Services Garment Processing Facilities (excludes Cleanroom Service Centers) are validated for sterile garment processing, and have a quality management system that is ISO 9001 certified.
This post is related to:
Contamination Control: Cleanrooms, Gloveboxes, Hoods, Isolators
