Environmental Monitoring for Cleanrooms and Controlled Environments

ISBN-13: 9780824723590 / Angielski / Twarda / 2006 / 230 str.

Dixon; Dixon Edward Dixon; C. Edward Dixon

Opis

Spanning every subject of critical importance to the field of environmental monitoring, this guide offers step-by-step guidance on the assessment of air, surfaces, water, action levels, instruments, and procedures in cleanroom facilities. Emphasizing the importance of data gleaned from evaluation and sampling studies, this guide shows how to use this information to reduce contamination risks and provide safe and stable operating conditions for the development of pharmaceutical products. This reference also covers certification/requalification and new ISO standards.

Spis treści

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.

O autorze

Anne Marie Dixon