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.
Table of Contents
The Behavior of Particles in Cleanrooms. The Application of the New ISO Cleanroom Standards. Cleanroom Certification and Particulate Testing. Air Viable Monitoring. Microbial Surface Sampling. Endotoxin. Water Monitoring. Process Simulations (Media Fills). Sterility Testing.