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Biocontamination Control for Pharmaceutical and Healthcare
Sandle T
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Book Information
Edition:
1st
Publisher:
Saunders, W. B.
ISBN:
0-12-814912-4 (0128149124)
ISBN-13:
978-0-12-814912-6 (9780128149126)
Binding:
E E Book + ProQuest Ebook Central
Copyright:
2019
Publish Date:
01/19
Weight:
0.00 Lbs.
Subject Class:
RET (Returns)
Remarks:
A New Edition of this Title is Available
Return Policy:
Non-Returnable.
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Class Specifications
Discipline:
Pharmacology
Subject Definition:
Technology, Pharmaceutical; Sterilization; Drug Contaminatio
NLM Class:
QV 778
LC Class:
RS199
Abstract:
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 Pharmaceuticals 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 strategyAllows a facility to understand the main biocontamination risks to medicinal productsAssists the reader in navigating regulatory requirements and reducing process risksProvides insight into developing an environmental monitoring programmeCovers the types of rapid microbiological monitoring methods now available, as well as current legislation
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