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 : 4/5 from 21 reviews
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Read or download book entitled Biocontamination Control for Pharmaceutical and Healthcare written by Tim Sandle which was release on 15 January 2019, this book published by Academic Press. Available in PDF, EPUB and Kindle Format. Book excerpt: 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 ...

Biocontamination Control for Pharmaceuticals and Healthcare

Biocontamination Control for Pharmaceuticals and Healthcare
  • Author : Tim Sandle
  • Publisher : Academic Press
  • Release Date : 2018-11-30
  • Total pages : 374
  • ISBN : 9780128149119
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Summary : 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. This key part of controlling risk escalation can lead to the contamination of medicinal products, hence necessary tracking precautions are essential. Regulatory authorities have challenged ...

Aulton s Pharmaceutics E Book

Aulton s Pharmaceutics E Book
  • Author : Kevin M.G. Taylor,Michael E. Aulton
  • Publisher : Elsevier Health Sciences
  • Release Date : 2021-04-23
  • Total pages : 968
  • ISBN : 9780128149119
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Summary : The essential pharmaceutics textbook One of the world’s best-known texts on pharmaceutics, Aulton's Pharmaceutics offers a complete course in one book for students in all years of undergraduate pharmacy and pharmaceutical sciences degrees. Thoroughly revised, updated and extended by experts in their fields and edited by Professors Kevin Taylor ...

An Industrial IoT Approach for Pharmaceutical Industry Growth

An Industrial IoT Approach for Pharmaceutical Industry Growth
  • Author : Valentina Emilia Balas,Vijender Kumar Solanki,Raghvendra Kumar
  • Publisher : Academic Press
  • Release Date : 2020-05-15
  • Total pages : 382
  • ISBN : 9780128149119
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Summary : An Industrial IoT Approach for Pharmaceutical Industry Growth, Volume Two uses an innovative approach to explore how the Internet of Things (IoT) and big data can improve approaches and make discoveries. Rapid growth of the IoT has encouraged many companies in the manufacturing sector to make use of this technology ...

Cannabis Laboratory Fundamentals

Cannabis Laboratory Fundamentals
  • Author : Shaun R. Opie
  • Publisher : Springer Nature
  • Release Date : 2021-03-09
  • Total pages : 325
  • ISBN : 9780128149119
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Summary : The legislative requirement for cannabis to undergo laboratory testing has followed legalization of medical and recreational use in every U.S. state to date. Cannabis safety testing is a new investment opportunity within the emerging cannabis market that is separate from cultivation, processing, and distribution, allowing individuals and organizations who ...

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 ...

Healthcare Sterilisation

Healthcare Sterilisation
  • Author : Wayne J Rogers
  • Publisher : Smithers Rapra
  • Release Date : 2014-06-09
  • Total pages : 540
  • ISBN : 9780128149119
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Summary : The collection of topics in the second volume of this book challenges the reader to think beyond standard methods and question why certain current procedures remain static while technological advances abound in other aspects of sterilisation technology. By small means, better practices may come to pass to help answer some ...

Pharmaceutical Microbiological Quality Assurance and Control

Pharmaceutical Microbiological Quality Assurance and Control
  • Author : David Roesti,Marcel Goverde
  • Publisher : John Wiley & Sons
  • Release Date : 2020-01-02
  • 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 ...

Clean Room Technology in ART Clinics

Clean Room Technology in ART Clinics
  • Author : Sandro C. Esteves,Alex C. Varghese,Kathryn C. Worrilow
  • Publisher : CRC Press
  • Release Date : 2016-11-18
  • Total pages : 424
  • ISBN : 9780128149119
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Summary : Regulatory agencies worldwide have issued directives or such requirements for air quality standards in embryology laboratories. This practical guide reviews the application of clean room technology or controlled environments specifically suited for Assisted Reproductive Technology (ART) Units. Its comprehensive coverage includes material on airborne particles and volatile organic compounds, including ...

Sterility Sterilisation and Sterility Assurance for Pharmaceuticals

Sterility  Sterilisation and Sterility Assurance for Pharmaceuticals
  • Author : Tim Sandle
  • Publisher : Elsevier
  • Release Date : 2013-10-31
  • Total pages : 362
  • ISBN : 9780128149119
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Summary : Failure to adequately control any microbial challenge associated within process or product by robust sterilisation will result in a contaminated marketed product, with potential harm to the patient. Sterilisation is therefore of great importance to healthcare and the manufacturers of medical devices and pharmaceuticals. Sterility, sterilisation and sterility assurance for ...

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 ...

Antisepsis Disinfection and Sterilization

Antisepsis  Disinfection  and Sterilization
  • Author : Gerald E. McDonnell
  • Publisher : John Wiley & Sons
  • Release Date : 2020-07-10
  • Total pages : 410
  • ISBN : 9780128149119
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Summary : Antisepsis, Disinfection, and Sterilization: Types, Action, and Resistance, by Gerald E. McDonnell, is a detailed and accessible presentation of the current methods of microbial control. Each major category, such as physical disinfection methods, is given a chapter, in which theory, spectrum of activity, advantages, disadvantages, and modes of action of ...