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Monitoring and Controlling Microorganisms in the Manufacture of Medical Products

G.A. Mosley
Biotest Laboratories, Inc., US

Keywords:
aseptic, microorganisms, pathogens

Abstract:
Manufacturing medical products aseptically or for terminal sterilization requires monitoring and control of microorganisms. The microbes that may adversely affect the product quality attributes will depend on the product, its intended application, method of manufacture and sterilization. If an organization manufactures multiple products in a single facility, each product may have different microbes with the potential to produce undesirable product results. Potential contaminants may involve hundreds or thousands of species. Any approach to this problem must consider the cost/benefit of the start-up and maintenance of such a program. This presentation will present the concept of managing microbes as an approach which is both cost effective and proactive and should prove useful to those responsible for operation, testing and quality control functions.

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