Guide to microbiological control in pharmaceuticals and medical devices
著者
書誌事項
Guide to microbiological control in pharmaceuticals and medical devices
CRC Press, c2007
2nd ed
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注記
Includes bibliographical references and index
内容説明・目次
内容説明
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 from many fields to address potential problems in advance and implement suitable strategies at the earliest stages of development.
目次
Introduction to microbiology. Microbial contamination: spoilage and hazard. Microbial ecology of the production process. The design of controlled environments. Microbiological considerations for biotechnological products. Microbiological considerations in the production of medical devices. Good manufacturing practice in the control of contamination. Dispersion of airborne contaminants and contamination risks in clean rooms. Monitoring microbiological quality: conventional testing methods. Monitoring microbiological quality: application of rapid microbiological methods to pharmaceuticals. Principles of sterilization. Sterilization methods. Assurance of sterility by process validation. Principles of preservation. Antimicrobial preservatives and their properties.
Preservative stability and efficacy: formulation influences. Package integrity testing. Official methods of preservative evaluation and testing. Preservative evaluation and testing : the linear regression method. Preservatives, antimicrobial agents and antioxidants: registration and regulatory affairs. Microbial standards for pharmaceuticals. Risk management and microbiological auditing.
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