Report On The Prevention Of Microbial Contamination Of Medicinal Products
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Report On The Prevention Of Microbial Contamination Of Medicinal Products
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Author : Great Britain. Medicines Commission
language : en
Publisher:
Release Date : 1973
Report On The Prevention Of Microbial Contamination Of Medicinal Products written by Great Britain. Medicines Commission and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1973 with Medical categories.
Microbial Contamination Control In The Pharmaceutical Industry
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Author : Luis Jimenez
language : en
Publisher: CRC Press
Release Date : 2019-10-17
Microbial Contamination Control In The Pharmaceutical Industry written by Luis Jimenez and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-10-17 with categories.
This authoritative reference presents an up-to-date review of the testing methods, emerging technologies, and analytical systems and procedures used to prevent the microbial contamination of pharmaceutical processes, products, and environments. It identifies new tools for sample analysis and evaluation and the impact of these advancements on the continuous supply and manufacturing of pharmaceutical products. With more than 100 tables and 430 current references, the book contains a detailed analysis of microbial contamination recalls for nonsterile and sterile pharmaceutical products, demonstrating the distribution of microorganisms worldwide and the identification by geographical regions.
Pharmaceutical Microbiological Quality Assurance And Control
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Author : David Roesti
language : en
Publisher: John Wiley & Sons
Release Date : 2020-01-02
Pharmaceutical Microbiological Quality Assurance And Control written by David Roesti and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-01-02 with Technology & Engineering categories.
Relying on practical examples from the authors’ experience, this book provides a thorough and modern approach to controlling and monitoring microbial contaminations during the manufacturing of non-sterile pharmaceuticals. Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC Presents the latest developments in both regulatory expectations and technical advancements Provides guidance on statistical tools for risk assessment and trending of microbiological data Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC Presents the latest developments in both regulatory expectations and technical advancements Provides guidance on statistical tools for risk assessment and trending of microbiological data Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks
Microbial Contamination Control In Parenteral Manufacturing
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Author : Kevin Williams
language : en
Publisher: CRC Press
Release Date : 2004-05-20
Microbial Contamination Control In Parenteral Manufacturing written by Kevin Williams and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2004-05-20 with Medical categories.
This reference surveys emerging trends, concepts, and procedures used in the characterization and control of contaminants; the sterile production of traditional drugs and biologics; the design, construction, and validation of new parenteral facilities; and the monitoring of clean environments-vividly illustrating the routes by which products, proce
Microbiological Contamination Control In Pharmaceutical Clean Rooms
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Author : Nigel Halls
language : en
Publisher: CRC Press
Release Date : 2016-04-19
Microbiological Contamination Control In Pharmaceutical Clean Rooms written by Nigel Halls and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-04-19 with Medical categories.
Contamination control in pharmaceutical clean rooms has developed from a jumble of science and engineering, knowledge of what has worked well or badly in the past, dependent upon the technology available at the time the clean room was built and subsequent technological developments. Surrounding it all is a blanket of regulations. Taking a multidisc
Guide To Microbiological Control In Pharmaceuticals
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Author : S. P. Denyer
language : en
Publisher: Taylor & Francis Group
Release Date : 1990
Guide To Microbiological Control In Pharmaceuticals written by S. P. Denyer and has been published by Taylor & Francis Group this book supported file pdf, txt, epub, kindle and other format this book has been release on 1990 with Business & Economics categories.
A handbook to the micro-organism as a contaminant and as a potential growth medium, focusing on the problems of microbiological control in pharmaceutical product design and manufacture. Topics include the relative susceptibilities of product types and ingredients and factory hygiene.
Handbook Of Microbiological Quality Control In Pharmaceuticals And Medical Devices
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Author : Rosamund M. Baird
language : en
Publisher: CRC Press
Release Date : 2000-08-17
Handbook Of Microbiological Quality Control In Pharmaceuticals And Medical Devices written by Rosamund M. Baird and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2000-08-17 with Medical categories.
Microbiologists working in both the pharmaceutical and medical device industries, face considerable challenges in keeping abreast of the myriad microbiological references available to them, and the continuously evolving regulatory requirements. The Handbook of Microbiological Quality Control provides a unique distillation of such material, by provi
Guide To Microbiological Control In Pharmaceuticals And Medical Devices Second Edition
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Author : Stephen P. Denyer
language : en
Publisher: CRC Press
Release Date : 2006-12-26
Guide To Microbiological Control In Pharmaceuticals And Medical Devices Second Edition written by Stephen P. Denyer and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2006-12-26 with Science categories.
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.
Biocontamination Control For Pharmaceuticals And Healthcare
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Author : Tim Sandle
language : en
Publisher: Elsevier
Release Date : 2024-02-09
Biocontamination Control For Pharmaceuticals And Healthcare written by Tim Sandle and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-02-09 with Medical categories.
Biocontamination Control for Pharmaceuticals and Healthcare outlines a biocontamination strategy that tracks bio-burden control and reduction at each transition in classified areas of a facility. The first edition of the book covered many of the aspects of the strategy, but the new official guidance signals that a roadmap is required to fully comply with its requirements. Completely updated with the newest version of the EU-GPM (EN17141) the new edition expands the coverage of quality risk management and new complete examples to help professionals bridge the gap between regulation and implementation. Biocontamination Control for Pharmaceuticals and Healthcare offers professionals in pharma quality control and related areas guidance on building a complete biocontamination strategy. Includes the most current regulations Contains three new chapters, including Application of Quality Risk Management and its Application in Biocontamination Control, Designing an Environmental Monitoring Programme, and Synthesis: An Anatomy of a Contamination Control Strategy Offers practical guidance on building a complete biocontamination strategy
Sources Of Contamination In Medicinal Products And Medical Devices
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Author : Denise Bohrer
language : en
Publisher: John Wiley & Sons
Release Date : 2012-09-25
Sources Of Contamination In Medicinal Products And Medical Devices written by Denise Bohrer and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-09-25 with Science categories.
The first one-volume guide to sources of contamination in pharmaceuticals and medical devices Most books dealing with contaminants in medicinal products often focus on analytical methods for detecting nonspecific impurities. Key to the work of the pharmaceutical chemist, this unique reference helps identify the sources of contamination in medicinal and pharmaceutical products and medical devices. Divided into three parts, Sources of Contamination in Medicinal Products and Medical Devices covers chemical, microbiological, and physical (particulate matter) contamination, including those originating from sterilization procedures. As compelling as a medical documentary, the book sheds light on how impurities and contaminants can enter the human body transported via a specific product or treatment. Focusing on only those medicinal products and medical devices that may lead to exposure to contaminants harmful to human health, the book offers a comprehensive, systematic look at the entire universe of medical contamination: Chemical contaminants including residual solvents, catalyst residuals, and genotoxic impurities in active pharmaceutical ingredients (APIs) Diagnostic imaging agents (i.e., radiopharmaceuticals and contrast agents) Microbiological and endotoxin contamination involving single and multiple dose products, medical devices, and biofilms Contamination from sterilization procedures, residuals from radiation sterilization, ionizing radiation on packaging materials and medical devices Medicinal gases and volatile anesthetics Biopharmaceuticals including recombinant DNA technology products Extractables and leachables from containers made of glass, plastics, and metal Each section of the book contains information on what contaminants could be expected in a particular product, and how they were generated and reached that product. With up-to-date regulatory guidelines for determining contamination, as well as methods for assessing, quantifying, avoiding and removing contaminants, Sources of Contamination in Medicinal Products and Medical Devices is essential to fully understanding the specific threats that undermine the safety of medicines and medical devices.