Guide To Microbiological Control In Pharmaceuticals And Medical Devices

Author : Stephen P. Denyer,Rosamund M. Baird
Publisher : CRC Press
Page : 500 pages
File Size : 46,7 Mb
Release : 2006-12-26
Category : Science
ISBN : 9781420021622

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Guide to Microbiological Control in Pharmaceuticals and Medical Devices, Second Edition by Stephen P. Denyer,Rosamund M. Baird Pdf

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,Rosamund M. Baird
Publisher : Unknown
Page : 482 pages
File Size : 55,5 Mb
Release : 2007
Category : MEDICAL
ISBN : 0367800926

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Guide to Microbiological Control in Pharmaceuticals and Medical Devices by S. P. Denyer,Rosamund M. Baird Pdf

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,Norman A. Hodges,Stephen P. Denyer
Publisher : CRC Press
Page : 274 pages
File Size : 54,6 Mb
Release : 2000-08-17
Category : Medical
ISBN : 9780203305195

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Handbook of Microbiological Quality Control in Pharmaceuticals and Medical Devices by Rosamund M. Baird,Norman A. Hodges,Stephen P. Denyer Pdf

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 : S. P. Denyer,Rosamund M. Baird
Publisher : Taylor & Francis Group
Page : 400 pages
File Size : 40,7 Mb
Release : 1990
Category : Drugs
ISBN : UOM:39015019810871

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Guide to Microbiological Control in Pharmaceuticals by S. P. Denyer,Rosamund M. Baird Pdf

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 : David Roesti,Marcel Goverde
Publisher : John Wiley & Sons
Page : 594 pages
File Size : 46,8 Mb
Release : 2020-01-02
Category : Technology & Engineering
ISBN : 9781119356073

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Pharmaceutical Microbiological Quality Assurance and Control by David Roesti,Marcel Goverde Pdf

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 : Denise Bohrer
Publisher : John Wiley & Sons
Page : 592 pages
File Size : 40,9 Mb
Release : 2012-11-19
Category : Science
ISBN : 9780470487501

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Sources of Contamination in Medicinal Products and Medical Devices by Denise Bohrer Pdf

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 : Anonim
Publisher : Unknown
Page : 964 pages
File Size : 43,7 Mb
Release : 2011
Category : Pharmaceutical microbiology
ISBN : 8190646745

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Microbiology and Sterility Assurance in Pharmaceuticals and Medical Devices by Anonim Pdf

Author : United States Food and Drug Administration
Publisher : Createspace Independent Publishing Platform
Page : 92 pages
File Size : 51,8 Mb
Release : 2017-09-21
Category : Electronic
ISBN : 1976578671

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Pharmaceutical Microbiology Manual by United States Food and Drug Administration Pdf

Manual and is a supplement to the United States Pharmacopeia (USP) for pharmaceutical microbiology testing, including antimicrobial effectiveness testing, microbial examination of non-sterile products, sterility testing, bacterial endotoxin testing, particulate matter, device bioburden and environmental monitoring testing. The goal of this manual is to provide an ORA/CDER harmonized framework on the knowledge, methods and tools needed, and to apply the appropriate scientific standards required to assess the safety and efficacy of medical products within FDA testing laboratories. The PMM has expanded to include some rapid screening techniques along with a new section that covers inspectional guidance for microbiologists that conduct team inspections. This manual was developed by members of the Pharmaceutical Microbiology Workgroup and includes individuals with specialized experience and training. The instructions in this document are guidelines for FDA analysts. When available, analysts should use procedures and worksheets that are standardized and harmonized across all ORA field labs, along with the PMM, when performing analyses related to product testing of pharmaceuticals and medical devices. When changes or deviations are necessary, documentation should be completed per the laboratory's Quality Management System. Generally, these changes should originate from situations such as new products, unusual products, or unique situations. This manual was written to reduce compendia method ambiguity and increase standardization between FDA field laboratories. By providing clearer instructions to FDA ORA labs, greater transparency can be provided to both industry and the public. However, it should be emphasized that this manual is a supplement, and does not replace any information in USP or applicable FDA official guidance references. The PMM does not relieve any person or laboratory from the responsibility of ensuring that the methods being employed from the manual are fit for use, and that all testing is validated and/or verified by the user. The PMM will continually be revised as newer products, platforms and technologies emerge or any significant scientific gaps are identified with product testing. Reference to any commercial materials, equipment, or process in the PMM does not in any way constitute approval, endorsement, or recommendation by the U.S. Food and Drug Administration.

Author : United States. Food and Drug Administration. Division of Microbiology
Publisher : Unknown
Page : 180 pages
File Size : 40,8 Mb
Release : 1969
Category : Microbiology
ISBN : STANFORD:36105214583721

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Bacteriological Analytical Manual by United States. Food and Drug Administration. Division of Microbiology Pdf

Author : Lucia Clontz
Publisher : CRC Press
Page : 280 pages
File Size : 51,8 Mb
Release : 2008-10-14
Category : Science
ISBN : 1420053493

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Microbial Limit and Bioburden Tests by Lucia Clontz Pdf

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 changes. Microbial Limit and Bioburden Tests: Validation Approaches and Global Requirements guides readers through the various microbiological methods listed in the compendia with easy-to-follow diagrams and approaches to validations of such test methodologies. Includes New and Updated Material Now in its second edition, this work is the culmination of research and discussions with technical experts, as well as USP and FDA representatives on various topics of interest to the pharmaceutical microbiologist and those responsible for the microbial quality of products, materials, equipment, and manufacturing facilities. New in this edition is an entire chapter dedicated to the topic of biofilms and their impact on pharmaceutical and biopharmaceutical operations. The subject of rapid methods in microbiology has been expanded and includes a discussion on the validation of alternative microbiological methods and a case study on microbial identification in support of a product contamination investigation. Substantially updated and revised, this book assists readers in understanding the fundamental issues associated with pharmaceutical microbiology and provides them with tools to create effective microbial contamination control and microbial testing programs for the areas under their responsibility.

Author : Tim Sandle
Publisher : Elsevier
Page : 510 pages
File Size : 43,7 Mb
Release : 2024-02-09
Category : Medical
ISBN : 9780443216015

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Biocontamination Control for Pharmaceuticals and Healthcare by Tim Sandle Pdf

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 : Brendan F. Gilmore,Stephen P. Denyer
Publisher : John Wiley & Sons
Page : 580 pages
File Size : 53,7 Mb
Release : 2023-04-10
Category : Medical
ISBN : 9781119434498

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Hugo and Russell's Pharmaceutical Microbiology by Brendan F. Gilmore,Stephen P. Denyer Pdf

Hugo & Russell’s Pharmaceutical Microbiology Discover the very latest developments in pharmaceutical microbiology in the 9th edition of this popular textbook Microbiology is one of the essential pharmaceutical sciences upon which the study and practice of pharmacy is built. It has a bearing on all aspects of the manufacture of medicines and sterile products, from their design and development to their delivery as quality products. Few interventions are more central to modern medicine than the treatment of infection, where antibiosis, vaccination and hygienic practices have essential roles to play. The COVID-19 pandemic, the appearance of new pathogens and the rise of antibiotic resistance have demonstrated most completely the need for pharmaceutical practitioners, researchers and industrial scientists to be fully conversant with this field. The 9th edition of Hugo and Russell’s Pharmaceutical Microbiology has been updated to meet this need. Having long served as the sole comprehensive textbook covering this subject, it has now been adapted to a critical new period in the advancement of medical and pharmaceutical research and development. Its experienced editors have incorporated contributions from subject experts and created a text which will serve the next generation of pharmacy students, pharmaceutical industry scientists and researchers. In this ninth edition of Hugo and Russell’s Pharmaceutical Microbiology, readers will find: A mix of established and new authors bringing practical and research experience to their chapters Material covering the fundamentals of microbiology, microbial behavior and laboratory investigation Revised chapters incorporating new material on microbe-host interactions, antibiotic resistance, emerging pathogens, public health microbiology, healthcare-associated infection and pharmaceutical manufacture Emerging understandings from the COVID-19 pandemic on infection prevention and control and vaccine development Practitioners providing their insights on clinical practice and pharmaceutical production An accompanying website incorporating teaching resources Hugo and Russell’s Pharmaceutical Microbiology, 9th edition promises to remain the essential text for pharmacy and medical students, as well as researchers and industry professionals.

Author : Michael J. Akers
Publisher : CRC Press
Page : 516 pages
File Size : 40,9 Mb
Release : 2016-04-19
Category : Medical
ISBN : 9781420020564

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Sterile Drug Products by Michael J. Akers Pdf

Sterile Drug Products: Formulation, Packaging, Manufacturing, and Quality teaches the basic principles of the development and manufacture of high quality sterile dosage forms. The author has 38 years of experience in the development and manufacture of sterile dosage forms including solutions, suspensions, ophthalmics and freeze dried products. This book is based on the courses he has delivered for over three decades, to over 3000 participants, and is intended to remain relevant for the indefinite future even as new technologies and new applications of old technologies become common. This is an ideal reference book for those working directly and indirectly with sterile dosage forms, be it product development (formulation, package, process, analytical), manufacturing, quality control, quality assurance, regulatory, purchasing, or project management. This book is also intended as an educational resource for the pharmaceutical and biopharmaceutical industry and pharmacy schools, providing basic knowledge and principles in four main areas of parenteral science and technology: Product development, including formulation, packaging, and process development. Manufacturing, including basic teaching on all the primary unit operations involved in preparation of sterile products and the underlying importance of contamination control. Quality and regulatory, including the application of good manufacturing practice regulations, aseptic processing guidelines, and unique quality control testing methods for the sterile dosage form Clinical aspects, including administration, potential hazards, and biopharmaceutics of sterile products in a clinical setting.

Author : Adam P. Fraise,Jean-Yves Maillard,Syed Sattar
Publisher : John Wiley & Sons
Page : 626 pages
File Size : 54,7 Mb
Release : 2013-02-18
Category : Medical
ISBN : 9781444333251

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Russell, Hugo and Ayliffe's Principles and Practice of Disinfection, Preservation and Sterilization by Adam P. Fraise,Jean-Yves Maillard,Syed Sattar Pdf

The new edition of this established and highly respected text is THE definitive reference in its field. It details methods for the elimination or prevention/control of microbial growth, and features: New chapters on bioterrorism and community healthcare New chapters on microbicide regulations in the EU, USA and Canada Latest material on microbial resistance to microbicides Updated material on new and emerging technologies, focusing on special problems in hospitals, dentistry and pharmaceutical practice Practical advice on problems of disinfection and antiseptics in healthcare A systematic review of sterilization methods, with uses and advantages outlined for each Evaluation of disinfectants and their mechanisms of action with respect to current regulations The differences between European and North American regulations are highlighted throughout, making this a truly global work, ideal for worldwide healthcare professionals working in infectious diseases and infection control.

Author : Stephen P. Denyer,Norman A. Hodges,Sean P. Gorman,Brendan F. Gilmore
Publisher : John Wiley & Sons
Page : 456 pages
File Size : 53,7 Mb
Release : 2011-11-22
Category : Medical
ISBN : 9781118293829

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Hugo and Russell's Pharmaceutical Microbiology by Stephen P. Denyer,Norman A. Hodges,Sean P. Gorman,Brendan F. Gilmore Pdf

Pharmaceutical microbiology has a bearing on all aspects of pharmacy, from the manufacture and quality control of pharmaceutical products through to an understanding of the mode of action of antibiotics. Fully revised and restructured, drawing on the contributions of subject experts, and including material relevant to the European curricula in pharmacy, the eighth edition covers: biology of micro-organisms pathogens and host response prescribing therapeutics contamination and infection control pharmaceutical production current trends and new directions Hugo and Russell’s Pharmaceutical Microbiology, a standard text for Schools of Pharmacy for seven editions, continues to be a user-friendly and authoritative guide for both students and practitioners of pharmacy and pharmaceutical microbiology. 'Highly Commended' in the Pharmacology section of the 2012 BMA Book Awards