Guide to Microbiological Control in Pharmaceuticals and Medical Devices

出版者:CRC Pr I Llc

作者:Denyer, Stephen P. (EDT)/ Baird, Rosamund M. (EDT)

页数:504

出版时间:2006-12

价格:$ 214.64

装帧:HRD

isbn号码:9780748406159

Microbiological matters continue to exercise considerable influence on product quality. In both the pharmaceutical and medical device industries, products of greater sophistication, along with evolving regulatory requirements, are elevating the challenges related to maintaining microbiological integrity. Nowadays, all scientists working in product development and production need to be versed in modern methods of contamination control. Updated to reflect the technological and regulatory changes that have come into play since publication of the first edition, the "Guide to Microbiological Control in Pharmaceuticals and Medical Devices, Second Edition" covers those principal aspects of microbiology that are relevant to the preformulation, formulation, manufacturing, and license application stages involved with the production of pharmaceuticals, while expanding the book's focus to include medical devices. In recognition of the diverse disciplines involved in pharmaceutical and medical device production, this work provides a brief introduction to microbiology geared towards the nonmicrobiologist. Covering good manufacturing practice in the control of contamination, the text explores monitoring microbiological quality, the preservation of pharmaceutical formulations and principles of sterilization, including microbiological-specific considerations for biotechnological products and other medical devices. It also provides additional materials on package integrity testing, and the evaluation of contamination risks in clean rooms. The editors have produced a companion text, the "Handbook of Microbiological Quality Control in Pharmaceuticals and Medical Devices", which when paired with the Guide offers a complete theoretical and practical treatment of microbiological control. Concerns with contamination will continue to be inextricably linked to the development of pharmaceuticals and medical devices. Many new methods and regulations have been developed to meet those concerns. This book provides a comprehensive distillation of information that would otherwise remain scattered throughout the literature. It allows scientists from many fields to address potential problems in advance and implement suitable strategies at the earliest stages of development.