Sterilization Validation of Pharmaceuticals

Abstract

Bioburden is measure of microbial contamination or microbial load; the amount of microorganisms contaminating an object. Each lot of a component, drug product container, or closure with potential for microbiological contamination that is frightful in perspective of its planned utilize might be subjected to microbiological tests before utilize. Appropriate written procedures, designed to prevent objectionable microorganisms in drug products not required to be sterile, shall be established and followed. Microbiological monitoring of the manufacturing environment can serve as an adjunct to control and generally is a qualitative assessment tool in a properly implemented formal risk-based microbiological control program. A monitoring program corresponding with the product bioburden risk can help confirm the effectiveness of microbiological controls and may facilitate early detection of potential problems. The techniques utilized for microbial monitoring should be capable of isolating the numbers and types of organisms that have been deemed significant relative to in-process system control and product impact for each individual system