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Guide to Microbiological Control in Pharmaceuticals and Medical Devices (Hardcover, 2nd edition)
Loot Price: R6,321
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Guide to Microbiological Control in Pharmaceuticals and Medical Devices (Hardcover, 2nd edition)
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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.
Updated to reflect technological and regulatory changes, the Guide
to Microbiological Control in Pharmaceuticals and Medical Devices,
Second Edition covers thoseprincipal aspects of microbiology that
arerelevant 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.
The editors have produced a companion text, the Handbook of
Microbiological Quality Control in Pharmaceuticals and Medical
Devices ("see reverse"), which when paired with the Guide offers a
complete theoretical and practical treatment of microbiological
control.
This book provides a comprehensive distillation of information
concerning methodology and regulations that would otherwise remain
scattered throughout the literature. It allows scientists frommany
fields to address potential problems in advance and implement
suitable strategies at the earliest stages of development.
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