Monday 25 March 2019

Biocontamination control for pharmaceuticals and healthcare

A new book has been published – “Biocontamination Control for Pharmaceuticals and Healthcare” by written Tim Sandle.

The book 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 of the book are:

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

Table of Contents

1 Introduction
2. Sources of microbial contamination and risk profiling
3. GMP, regulations and standards
4. Biocontamination control
5. Introduction to cleanrooms and environmental monitoring
6. Viable monitoring methods
7. Selection of culture media
8. Non-viable monitoring
9. Rapid microbiological methods
10. Designing an environmental monitoring programme
11. Special Types of Environmental Monitoring
12. Cleanrooms and microflora
13. Assessment of pharmaceutical water systems
14. Data handling and trend analysis
15. Bioburden and endotoxin assessment of pharmaceutical processing
16. Risk assessment and investigation for environmental monitoring
17. Assessing and removing contamination risks from the process
18. The human factor
19. Biocontamination deviation management

374 pages


Sandle, T. (2019) Biocontamination Control for Pharmaceuticals and Healthcare, Academic Press, London, UK

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Monday 18 March 2019

Kenneth G. Chapman Award

Tim Sandle, Ph.D., Head of Microbiology and Sterility Assurance, Bio Products Laboratory Limited, has been awarded the prestigious Kenneth G. Chapman Award by the Institute of Validation Technology.

Ken Chapman served with Pfizer Inc for 43 years in various Production, R&D, and QC roles, retiring as Director of Corporate Quality Assurance Audit in 1994. He served on the Editorial Review Board of Pharmaceutical Technology and, in October 1988, was presented the Pharm. Tech. Publisher's Award at E. Rutherford, NJ. He also served on the Editorial Advisory Board of the Journal of Validation Technology and was honored with the Life Time Achievement Award by the Institute of Validation Technology (IVT).

See IVT -

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Wednesday 13 March 2019

Review of Standards for Disinfectants; and associated guidance

The Australian TGA have initiated a review into hard surface disinfectants. The TGA
invites comments on their proposed update. It is intended that the updated TGO will incorporate all relevant regulatory requirements, comprising:

Updated sections of TGO 54 that clarify existing requirements,
The labelling requirements of the former TGO 37(which has now sunset), and,
Standards and requirements contained within the guidelines for the evaluation of disinfectants.


Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Tuesday 12 March 2019

Pharmig News #74

A new edition of Pharmig News has been published. In the latest issue:
  • The hidden problems with relaundering microfibre mops by Karen Rossington
  • Endotoxin hot topics and issues by Ruth NoĆ© and Julie Roberts
  • Validation of contact plates for environmental monitoring by Merck KGaA, Darmstadt, Germany
  • Pharmig Membership Survey by Tim Sandle
  • Latest regulatory news
  • And more!
Copies have been sent out. If you would like to see a copy, please email:

Key reference:

Sandle, T. (2019) Pharmig membership survey, Pharmig News, Issue 74, pp9-12

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

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