Microbiological Contamination Control in Pharmaceutical Clean Rooms

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Author :
Publisher : CRC Press
ISBN 13 : 1420025805
Total Pages : 198 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Microbiological Contamination Control in Pharmaceutical Clean Rooms by : Nigel Halls

Download or read book Microbiological Contamination Control in Pharmaceutical Clean Rooms written by Nigel Halls and published by CRC Press. This book was released on 2016-04-19 with total page 198 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Introduction to Contamination Control and Cleanroom Technology

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Author :
Publisher : John Wiley & Sons
ISBN 13 : 3527613137
Total Pages : 179 pages
Book Rating : 4.5/5 (276 download)

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Book Synopsis Introduction to Contamination Control and Cleanroom Technology by : Matts Ramstorp

Download or read book Introduction to Contamination Control and Cleanroom Technology written by Matts Ramstorp and published by John Wiley & Sons. This book was released on 2008-07-11 with total page 179 pages. Available in PDF, EPUB and Kindle. Book excerpt: Contamination control is being used by more and more industries where the highest level of cleanliness and hygiene is of vital importance. This book covers the basic principles of contamination control and cleanroom technology from a holistic point of view. It deals with cleanliness and hygiene and their effects on the outcome of a process, reflecting the latest results from both scientific and practical points of view. The following topics are covered: contaminants and how they are measured cleanrooms and clean zones cleaning and decontamination cleanroom clothing the impact of people on cleanliness. Intended as an introduction to the area of contamination control, the text is also an excellent source of knowledge for people with both theoretical and practical experience. The Swedish version has been used for a long time within the Nordic countries as a basic training textbook within the pharmaceutical, microelectronics, food and beverage, optics and many other industries.

Cleanroom Microbiology for the Non-Microbiologist

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Publisher : CRC Press
ISBN 13 : 9780935184730
Total Pages : 168 pages
Book Rating : 4.1/5 (847 download)

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Book Synopsis Cleanroom Microbiology for the Non-Microbiologist by : David M. Carlberg

Download or read book Cleanroom Microbiology for the Non-Microbiologist written by David M. Carlberg and published by CRC Press. This book was released on 1995-04-30 with total page 168 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written for the professional who has an immediate need for the information but has little or no training in the subject, Cleanroom Microbiology for the Non-Microbiologist introduces principles of microbiology. It explains the consequences of microbiological contamination, what contamination is all about, how microorganisms grow, and how they can be controlled. The book introduces the vocabulary of microbiology and the types, sources, control, and elimination of organisms encountered in the manufacture of sterile products. Beginning with a discussion of the various types of organisms, the text then covers applications for bacterial detection, avoidance of contamination, cleanroom design considerations, and validation of disinfection methods. This book is especially relevant for supervisors and managers who need a sound understanding of contamination control and is particularly effective for use in training. It also is an excellent resource for validation engineers, quality assurance and non-microbiologist quality-control staff, maintenance personnel, and process development staff.

Environmental Monitoring for Cleanrooms and Controlled Environments

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Publisher : CRC Press
ISBN 13 : 1420014854
Total Pages : 254 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Environmental Monitoring for Cleanrooms and Controlled Environments by : Anne Marie Dixon

Download or read book Environmental Monitoring for Cleanrooms and Controlled Environments written by Anne Marie Dixon and published by CRC Press. This book was released on 2016-04-19 with total page 254 pages. Available in PDF, EPUB and Kindle. Book excerpt: A critical technology in the science of contamination control, environmental monitoring is a technique that provides important data on the quality of a process, processing environment, and final product, which can aid scientists in identifying and eliminating potential sources of contamination in cleanrooms and controlled environments. In response

Biocontamination Control for Pharmaceuticals and Healthcare

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Author :
Publisher : Elsevier
ISBN 13 : 0443216010
Total Pages : 510 pages
Book Rating : 4.4/5 (432 download)

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Book Synopsis Biocontamination Control for Pharmaceuticals and Healthcare by : Tim Sandle

Download or read book Biocontamination Control for Pharmaceuticals and Healthcare written by Tim Sandle and published by Elsevier. This book was released on 2024-01-28 with total page 510 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Microbial Contamination Control in Parenteral Manufacturing

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Publisher : CRC Press
ISBN 13 : 113553621X
Total Pages : 671 pages
Book Rating : 4.1/5 (355 download)

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Book Synopsis Microbial Contamination Control in Parenteral Manufacturing by : Kevin Williams

Download or read book Microbial Contamination Control in Parenteral Manufacturing written by Kevin Williams and published by CRC Press. This book was released on 2004-05-20 with total page 671 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Contamination Control in Practice

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Publisher : John Wiley & Sons
ISBN 13 : 3527612610
Total Pages : 202 pages
Book Rating : 4.5/5 (276 download)

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Book Synopsis Contamination Control in Practice by : Matts Ramstorp

Download or read book Contamination Control in Practice written by Matts Ramstorp and published by John Wiley & Sons. This book was released on 2008-06-25 with total page 202 pages. Available in PDF, EPUB and Kindle. Book excerpt: Contamination control has received great interest and found increasing use within several industrial branches including microelectronics, pharmaceuticals, food and beverages using various concepts of contamination control in their production, purification or packaging process. The book supplies a holistic view of contamination control, presenting the different types of contaminants in a summarized form. The focus is on how to protect products and processes from external contamination and also on different ways to take care of and control contaminants generated in the process. The aim is to eliminate them from a product or a process flow (e.g. through filtration), or to render them harmless (e.g. through sterilisation by moist heat). Product purity or the cleanliness of process flows are often complex matters and hard to define in easily understood terms. This book covers a variety of different techniques used in order to achieve and maintain certain overall cleanliness levels for both microbiological or inanimate particle contaminants. It supplies basic knowledge including validation aspects for industrial branches working with increased demands of cleanliness, for instance water purification, steam, pressurized gases and different flows in a process together with finished products.

Contamination Control and Cleanrooms

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Author :
Publisher : Springer Science & Business Media
ISBN 13 : 1468465120
Total Pages : 419 pages
Book Rating : 4.4/5 (684 download)

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Book Synopsis Contamination Control and Cleanrooms by : Alvin Lieberman

Download or read book Contamination Control and Cleanrooms written by Alvin Lieberman and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 419 pages. Available in PDF, EPUB and Kindle. Book excerpt: Contamination control standards and techniques for all phases of the production of high-technology products are spelled out in this applications-orientated guide. Practical cleaning methods for products and process fluids are accompanied by tips on selecting operations based on economy and efficiency. Explanations of contaminant measurement devices cover operation, error sources and remedial methods. Engineers will find vital data on contaminant sources, as well as coverage of operations and procedures that aggravate contaminant effects.

Pharmaceutical Microbiology

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Publisher : Woodhead Publishing
ISBN 13 : 0081000448
Total Pages : 318 pages
Book Rating : 4.0/5 (81 download)

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Book Synopsis Pharmaceutical Microbiology by : Tim Sandle

Download or read book Pharmaceutical Microbiology written by Tim Sandle and published by Woodhead Publishing. This book was released on 2015-10-09 with total page 318 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical Microbiology: Essentials for Quality Assurance and Quality Control presents that latest information on protecting pharmaceutical and healthcare products from spoilage by microorganisms, and protecting patients and consumers. With both sterile and non-sterile products, the effects can range from discoloration to the potential for fatality. The book provides an overview of the function of the pharmaceutical microbiologist and what they need to know, from regulatory filing and GMP, to laboratory design and management, and compendia tests and risk assessment tools and techniques. These key aspects are discussed through a series of dedicated chapters, with topics covering auditing, validation, data analysis, bioburden, toxins, microbial identification, culture media, and contamination control. Contains the applications of pharmaceutical microbiology in sterile and non-sterile products Presents the practical aspects of pharmaceutical microbiology testing Provides contamination control risks and remediation strategies, along with rapid microbiological methods Includes bioburden, endotoxin, and specific microbial risks Highlights relevant case studies and risk assessment scenarios

Guide to Microbiological Control in Pharmaceuticals and Medical Devices, Second Edition

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Author :
Publisher : CRC Press
ISBN 13 : 1420021621
Total Pages : 500 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Guide to Microbiological Control in Pharmaceuticals and Medical Devices, Second Edition by : Stephen P. Denyer

Download or read book Guide to Microbiological Control in Pharmaceuticals and Medical Devices, Second Edition written by Stephen P. Denyer and published by CRC Press. This book was released on 2006-12-26 with total page 500 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Preliminary Report on Microbiological Studies in a Laminar Down-flow Clean Room

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Author :
Publisher :
ISBN 13 :
Total Pages : 32 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Preliminary Report on Microbiological Studies in a Laminar Down-flow Clean Room by :

Download or read book Preliminary Report on Microbiological Studies in a Laminar Down-flow Clean Room written by and published by . This book was released on 1965 with total page 32 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Contamination Control Handbook

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Publisher :
ISBN 13 :
Total Pages : 420 pages
Book Rating : 4.F/5 ( download)

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Book Synopsis Contamination Control Handbook by : Sandia Laboratories

Download or read book Contamination Control Handbook written by Sandia Laboratories and published by . This book was released on 1969 with total page 420 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Microbial Contamination Control in the Pharmaceutical Industry

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Publisher : CRC Press
ISBN 13 : 9780367393946
Total Pages : 328 pages
Book Rating : 4.3/5 (939 download)

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Book Synopsis Microbial Contamination Control in the Pharmaceutical Industry by : Luis Jimenez

Download or read book Microbial Contamination Control in the Pharmaceutical Industry written by Luis Jimenez and published by CRC Press. This book was released on 2019-10-17 with total page 328 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 :
Publisher : John Wiley & Sons
ISBN 13 : 1119356121
Total Pages : 511 pages
Book Rating : 4.1/5 (193 download)

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Book Synopsis Pharmaceutical Microbiological Quality Assurance and Control by : David Roesti

Download or read book Pharmaceutical Microbiological Quality Assurance and Control written by David Roesti and published by John Wiley & Sons. This book was released on 2019-12-02 with total page 511 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Guide to Microbiological Control in Pharmaceuticals

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Author :
Publisher : Taylor & Francis Group
ISBN 13 :
Total Pages : 400 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Guide to Microbiological Control in Pharmaceuticals by : S. P. Denyer

Download or read book Guide to Microbiological Control in Pharmaceuticals written by S. P. Denyer and published by Taylor & Francis Group. This book was released on 1990 with total page 400 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Microbial Contamination Control Facilities

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Publisher :
ISBN 13 :
Total Pages : 218 pages
Book Rating : 4.:/5 (42 download)

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Book Synopsis Microbial Contamination Control Facilities by : Robert S. Runkle

Download or read book Microbial Contamination Control Facilities written by Robert S. Runkle and published by . This book was released on 1969 with total page 218 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Microbial Contamination Control in Parenteral Manufacturing

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Author :
Publisher : CRC Press
ISBN 13 : 9780824753207
Total Pages : 760 pages
Book Rating : 4.7/5 (532 download)

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Book Synopsis Microbial Contamination Control in Parenteral Manufacturing by : Kevin Williams

Download or read book Microbial Contamination Control in Parenteral Manufacturing written by Kevin Williams and published by CRC Press. This book was released on 2004-05-20 with total page 760 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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, processes, and manufacturing settings become contaminated through contact with the air, water, raw materials, and the actions of personnel, as well as the current methods necessary to successfully preclude contamination.