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Biocontamination Control for Pharmaceuticals and Healthcare by Tim Sandle

Biocontamination Control for Pharmaceuticals and Healthcare

by Tim Sandle
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₹10,433.00
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Book cover type: Paperback
  • ISBN13: 9780443216008
  • Binding: Paperback
  • Subject: N/A
  • Publisher: Academic Press
  • Publisher Imprint: Academic Press
  • Publication Date:
  • Pages: 508
  • Original Price: USD 180.0
  • Language: English
  • Edition: 2nd Ed.
  • Item Weight: 1070 grams
  • BISAC Subject(s): Quality Control, Industries / Pharmaceutical & Biotechnology, and Pharmacology

Biocontamination Control for Pharmaceuticals and Healthcare, Second Edition 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 covers 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), this new edition expands coverage of quality risk management and contains completely new examples to help professionals bridge the gap between regulation and implementation.

This book offers professionals in pharma quality control and related areas guidance on building a complete biocontamination strategy.

Sandle, Tim: - Dr. Sandle is a chartered biologist and holds a first class honours degree in Applied Biology; a Masters degree in education; and has a doctorate from Keele University.

He has over twenty-five years experience of microbiological research, quality assurance, and biopharmaceutical processing. This includes experience of designing, validating and operating a range of microbiological tests including sterility testing, bacterial endotoxin testing, bioburden and microbial enumeration, environmental monitoring, particle counting and water testing. In addition, Dr. Sandle is experienced in quality risk assessment, root cause analysis, and investigation.

Dr. Sandle is a tutor with the School of Pharmacy and Pharmaceutical Sciences, University of Manchester for the university's pharmaceutical microbiology MSc course, and at University College, London. In addition, Dr. Sandle has served on several national and international committees relating to pharmaceutical microbiology and cleanroom contamination control (including the ISO cleanroom standards and the National Blood Service advisory cleaning and disinfection committee).

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