Biocontamination Control for Pharmaceutical and Healthcare

Written By Tim Sandle
Biocontamination Control for Pharmaceutical and Healthcare
  • Publsiher : Academic Press
  • Release : 15 January 2019
  • ISBN : 9780128149119
  • Pages : 250 pages
  • Rating : /5 from reviews
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Download or read book entitled Biocontamination Control for Pharmaceutical and Healthcare by author: Tim Sandle which was release on 15 January 2019 and published by Academic Press with total page 250 pages . This book available in PDF, EPUB and Kindle Format. Biocontamination control concerns the risks to medicinal products from microorganisms, microbial by-products, and particulates. The risks of biocontamination in a well-designed facility stem from transfer on people and material surfaces, airborne contamination, and via utilities and interfaces. Biocontamination Control for Pharmaceutical and Healthcare outlines elements in a biocontamination strategy that tracks through a facility with bio-burden control and reduction at each transition in classified areas; this is a key part of controlling risk escalation to contaminating medicinal products. Regulatory authorities have challenged pharmaceutical and healthcare sectors, and those involved in Good Manufacturing Practice (GMP), to adopt a holistic approach to contamination control. Established ways of assessing contamination are limited, and therefore risk-based approaches are required. As well as using risk to assess types of contamination and where contamination can arise, new technologies are needed to introduce barriers between personnel and the environment, and to provide a rapid and more accurate assessment of risk. This book offers guidance on building an up to date and complete biocontamination strategy. Provides the information for a facility to build a complete biocontamination strategy Allows a facility to understand the main biocontamination risks to medicinal products Assists the reader in navigating regulatory requirements and reducing process risks Provides insight into developing an environmental monitoring programme Covers the types of rapid microbiological monitoring methods now available, as well as current legislation

Biocontamination Control for Pharmaceutical and Healthcare

Biocontamination Control for Pharmaceutical and Healthcare
  • Author : Tim Sandle
  • Publisher : Academic Press
  • Release Date : 2019-01-15
  • Total pages : 250
  • ISBN : 9780128149119
GET BOOK

Summary : Biocontamination control concerns the risks to medicinal products from microorganisms, microbial by-products, and particulates. The risks of biocontamination in a well-designed facility stem from transfer on people and material surfaces, airborne contamination, and via utilities and interfaces. Biocontamination Control for Pharmaceutical and Healthcare outlines elements in a biocontamination strategy that ...

Guide to Microbiological Control in Pharmaceuticals and Medical Devices Second Edition

Guide to Microbiological Control in Pharmaceuticals and Medical Devices  Second Edition
  • Author : Stephen P. Denyer,Rosamund M. Baird
  • Publisher : CRC Press
  • Release Date : 2006-12-26
  • Total pages : 504
  • ISBN : 9780128149119
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Summary : 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 ...

Pharmaceutical Microbiological Quality Assurance and Control

Pharmaceutical Microbiological Quality Assurance and Control
  • Author : David Roesti,Marcel Goverde
  • Publisher : John Wiley & Sons
  • Release Date : 2019-12-02
  • Total pages : 592
  • ISBN : 9780128149119
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Summary : 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 ...

Pharmaceutical Microbiology

Pharmaceutical Microbiology
  • Author : Tim Sandle
  • Publisher : Woodhead Publishing
  • Release Date : 2015-10-09
  • Total pages : 316
  • ISBN : 9780128149119
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Summary : 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 ...

Aseptic Pharmaceutical Manufacturing II

Aseptic Pharmaceutical Manufacturing II
  • Author : Michael J. Groves,Ram Murty
  • Publisher : CRC Press
  • Release Date : 1995-05-31
  • Total pages : 520
  • ISBN : 9780128149119
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Summary : Asceptic Pharmaceutical Manufacturing II explores the sophisticated technology, developments, and applications that allow aseptic processing to approach the sterility levels achieved with terminal sterilization. Written by experts in sterile manufacturing, this book covers aseptic technology, developments, and applications and makes a valuable contribution to understanding the issues involved in aseptic ...

Consultants and Consulting Organizations Directory

Consultants and Consulting Organizations Directory
  • Author : Anonim
  • Publisher : Unknown
  • Release Date : 2009
  • Total pages : 212
  • ISBN : 9780128149119
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Summary : Indexes are arranged by geographic area, activities, personal name, and consulting firm name....

The Future Practice of Contamination Control

The Future Practice of Contamination Control
  • Author : Anonim
  • Publisher : Mechanical Engineering Publications Limited
  • Release Date : 1992
  • Total pages : 656
  • ISBN : 9780128149119
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Summary : Read online The Future Practice of Contamination Control written by , published by Mechanical Engineering Publications Limited which was released on 1992. Download full The Future Practice of Contamination Control Books now! Available in PDF, ePub and Kindle....