Guide to microbiological control in pharmaceuticals and medical devices / edited by, Stephen P. Denyer, Rosamund M. Baird

Rev. ed. of: Guide to microbiological control in pharmaceuticals, 1990

Includes bibliographical references and index

Updated to reflect technological and regulatory changes, this book covers those principal aspects of microbiology that are relevant to the preformulation, formulation, manufacturing, and license application stages involved with the production of pharmaceuticals and 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 quality control, the preservation of formulations, and principles of sterilization, including microbiological-specific considerations for biotechnological products and other medical devices. It also provides additional materials on package integrity and contamination risks in clean rooms