Guide to Microbiological Control in Pharmaceuticals and Medical Devices

Providing a brief introduction to microbiology for the nonmicrobiologist, this book covers principal aspects of microbiology regarding the preformulation, formulation, manufacturing, and licensure of pharmaceuticals and medical devices. Covering good manufacturing practice in the control of contamination, the text explores monitoring microbiological quality, preserving pharmaceutical formulations, and applying principles of sterilization, including microbiologically specific considerations for biotechnology products and other medical devices. It also provides additional materials on testing package integrity and evaluating contamination risks in clean rooms.