Dixon A.M. (Ed.) Environmental Monitoring for Cleanrooms and Controlled Environments

Informa Healthcare USA, Inc., 2006. — 254 p. — (Drugs and the Pharmaceutical Sciences 164) — ISBN: 0824723597.A critical technology in the science of contamination control, environmental monitoring is a technique that provides important data on the quality of a process, processing environment, and final product, which can aid scientists in identifying and eliminating potential sources of contamination in cleanrooms and controlled environments. In response to the scattered industry and ISO standards and technical reports on the subject, this title provides comprehensive information about environmental monitoring, including monitoring of viable and non-viable air, surfaces, water, alert and action levels, trending, procedures for responding to excursions, certification/requalification, and the application of new ISO standards. Because the interpretation of results is vital in controlling contamination, several chapters discuss the presentation of data, trending, and investigations, and how they are valuable in reducing risk to the product, process, and patient.The Behavior of Particles in Cleanrooms
The Application of the New International Standards Organization Cleanroom Standards
Cleanroom Certification and Particulate Testing
Monitoring of Airborne Viable Particles
Microbial Surface Monitoring
Process Simulations (Media Fills)
Water Monitoring
Bacterial Endotoxin Testing
Fault Tree Analysis of the United States Pharmacopeia Sterility Test
Appendix 1.The Sterility Test—Big Moving Parts
Appendix 2. The Statistics of Endotoxin and Sterility Testing