Environmental Monitoring and Certification in Controlled Environments

Meeting Regulations and Achieving Effective Microbial Control for Pharmaceutical and Medical Device Manufacturers

Environmental Monitoring and Certification in Controlled Environments: Meeting Regulations and Achieving Effective Microbial Control for Pharmaceutical and Medical Device ManufacturersA white paper by Steven Wieczorek, Microtest.

Environmental testing and monitoring programs are essential elements in pharmaceutical and medical device manufacturing. Companies must understand industrial sterilization and contamination control procedures to bring products to market on time and on budget. Steven Wieczorek of Microtest Laboratories reviews the key elements of a best-practice environmental testing program, including sterilization standards, FDA requirements, and the critical factors in maintaining controlled environments.

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