Guide to Microbiological Control in Pharmaceuticals and Medical Devices
Editat de Stephen P. Denyer, Rosamund M. Bairden Limba Engleză Hardback – 26 dec 2006
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.
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Specificații
ISBN-13: 9780748406159
ISBN-10: 0748406158
Pagini: 498
Ilustrații: 49 b/w images
Dimensiuni: 156 x 234 x 35 mm
Greutate: 0.86 kg
Ediția:2
Editura: CRC Press
Colecția CRC Press
Locul publicării:Boca Raton, United States
ISBN-10: 0748406158
Pagini: 498
Ilustrații: 49 b/w images
Dimensiuni: 156 x 234 x 35 mm
Greutate: 0.86 kg
Ediția:2
Editura: CRC Press
Colecția CRC Press
Locul publicării:Boca Raton, United States
Public țintă
ProfessionalCuprins
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.
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.
Recenzii
“Considering the diversity of topics covered in the book and the diversity of the contributors, the style of writing is surprisingly consistent. Each chapter uses clear, easy-to-understand English… this book should appeal to a wide range of employees within the pharmaceutical and medical device industries, from Chief Executive Officers to managers, quality assurance/regulatory affairs assistants and laboratory staff.”
—David Pickard, Senior Technical Specialist and Microbiologist, London, UK, in Journal of Medical Device Regulation
—David Pickard, Senior Technical Specialist and Microbiologist, London, UK, in Journal of Medical Device Regulation
Notă biografică
Stephen P. Denyer, Rosamund M. Baird
Descriere
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.