Guide To Microbiological Control In Pharmaceuticals And Medical Devices Second Edition PDF Download
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Author | : Stephen P. Denyer |
Publisher | : CRC Press |
Total Pages | : 500 |
Release | : 2006-12-26 |
Genre | : Science |
ISBN | : 1420021621 |
Download Guide to Microbiological Control in Pharmaceuticals and Medical Devices, Second Edition Book in PDF, ePub and Kindle
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.
Author | : S. P. Denyer |
Publisher | : |
Total Pages | : 482 |
Release | : 2007 |
Genre | : MEDICAL |
ISBN | : 9780367800925 |
Download Guide to Microbiological Control in Pharmaceuticals and Medical Devices Book in PDF, ePub and Kindle
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 applica.
Author | : Rosamund M. Baird |
Publisher | : CRC Press |
Total Pages | : 274 |
Release | : 2000-08-17 |
Genre | : Medical |
ISBN | : 0203305191 |
Download Handbook of Microbiological Quality Control in Pharmaceuticals and Medical Devices Book in PDF, ePub and Kindle
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
Author | : Stephen P. |
Publisher | : |
Total Pages | : |
Release | : 2007 |
Genre | : |
ISBN | : |
Download Guide to Microbiological Control in Pharmaceuticals and Medical Devices Book in PDF, ePub and Kindle
A comprehensive review of the practical issues facing the industrial microbiologist of today including the appreciation of the developing role of rapid methods and the accompanying regulatory requirements.
Author | : David Roesti |
Publisher | : John Wiley & Sons |
Total Pages | : 594 |
Release | : 2020-01-02 |
Genre | : Technology & Engineering |
ISBN | : 1119356075 |
Download Pharmaceutical Microbiological Quality Assurance and Control Book in PDF, ePub and Kindle
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
Author | : S. P. Denyer |
Publisher | : Taylor & Francis Group |
Total Pages | : 400 |
Release | : 1990 |
Genre | : Business & Economics |
ISBN | : |
Download Guide to Microbiological Control in Pharmaceuticals Book in PDF, ePub and Kindle
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.
Author | : Denise Bohrer |
Publisher | : John Wiley & Sons |
Total Pages | : 592 |
Release | : 2012-09-25 |
Genre | : Science |
ISBN | : 1118449053 |
Download Sources of Contamination in Medicinal Products and Medical Devices Book in PDF, ePub and Kindle
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.
Author | : Lucia Clontz |
Publisher | : CRC Press |
Total Pages | : 344 |
Release | : 2008-10-14 |
Genre | : Science |
ISBN | : 1420053493 |
Download Microbial Limit and Bioburden Tests Book in PDF, ePub and Kindle
In recent years, the field of pharmaceutical microbiology has experienced numerous technological advances, accompanied by the publication of new and harmonized compendial methods. It is therefore imperative for those who are responsible for monitoring the microbial quality of pharmaceutical/biopharmaceutical products to keep abreast of the latest c
Author | : Tim Sandle |
Publisher | : Elsevier |
Total Pages | : 510 |
Release | : 2024-02-09 |
Genre | : Medical |
ISBN | : 0443216010 |
Download Biocontamination Control for Pharmaceuticals and Healthcare Book in PDF, ePub and Kindle
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
Author | : |
Publisher | : |
Total Pages | : 964 |
Release | : 2011 |
Genre | : Pharmaceutical microbiology |
ISBN | : 9788190646741 |
Download Microbiology and Sterility Assurance in Pharmaceuticals and Medical Devices Book in PDF, ePub and Kindle