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Elsevier

Biocontamination Control for Pharmaceuticals and Healthcare

Biocontamination Control for Pharmaceuticals and Healthcare outlines a biocontamination strategy that tracks bio-burden control and reduction at each transition in classifie… Read more

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Description

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 pharmaceutical companies, healthcare providers, and those in manufacturing practice to adopt a holistic approach to contamination control. 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 a complete biocontamination strategy.

Key features

  • Provides the information necessary for a facility to build a complete biocontamination strategy
  • Helps facilities understand the main biocontamination risks to medicinal products
  • Assists the reader in navigating regulatory requirements
  • Provides insight into developing an environmental monitoring program
  • Covers the types of rapid microbiological monitoring methods now available, as well as current legislation

Readership

Researchers in pharmaceutical companies, pharmacies, biotechnology companies, graduate and postgraduate students in pharmaceuticals and healthcare; Engineers, pharmacologists, Quality Assurance personnel; Medical professionals, medical device specialists

Table of contents

1. Introduction2. Sources of microbial contamination and risk profiling3. GMP, regulations and standards4. Biocontamination control5. Introduction to cleanrooms and environmental monitoring6. Viable monitoring methods7. Selection of culture media8. Non-viable monitoring 9. Rapid microbiological methods10. Designing an environmental monitoring programme11. Special Types of Environmental Monitoring12. Cleanrooms and microflora13. Assessment of pharmaceutical water systems14. Data handling and trend analysis15. Bioburden and endotoxin assessment of pharmaceutical processing16. Risk assessment and investigation for environmental monitoring17. Assessing and removing contamination risks from the process18. The human factor19. Biocontamination deviation management

Product details

About the author

TS

Tim Sandle

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).
Affiliations and expertise
Head of Microbiology, Bio Products Laboratory, Elstree, UKVisiting Tutor, School of Pharmacy and Pharmaceutical Sciences, Manchester University, UKCommittee Member of the Pharmaceutical Microbiology Interest Group (Pharmig), UK

View book on ScienceDirect

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