Tim Coles & Dr Helen Hale Article – Taming the Tyrannosaurus of Validation

Tim Coles, BSc (Hons), M.Phil., Technical Director, Pharminox Isolation Ltd., has worked in the field of isolator technology for over twenty years. He was a founding member of the UK Pharmaceutical Isolator Working Party that produced Pharmaceutical Isolators, Pharmaceutical Press, 2004, and more recently of the PDA committee that produced Technical Report No 51. “Biological Indicators for Gas and Vapour Phase Decontamination Processes” [for the validation of isolator sanitisation]. His book Isolation Technology – a Practical Guide, CRC Press Inc. 2004, is now in its second edition.

Dr Helen Hale has been Managing Director of Pharminox Isolation since 2015. Helen holds an MBA from the University of Leicester and a DBA in Management from Bradford University. She has spent most of her career in the financial services industry, as qualified financial advisor, consultant, and, finally, head of a several departments. Following a change in personal circumstances, Helen joined Pharminox Isolation in 2012 as Business Manager and found the shift into the pharmaceutical industry refreshing, although she has discovered that the complexities of compliance and validation in both industry sectors are similarly over-complicated, and could almost be complementary in many ways.

Their recent article “Taming the Tyrannosaurus of Validation” appearing in this months Clean Air & Containment Review, is an excellent read evaluating the current validation process as we know it.

We have made it available for you to read here – click here to read the article.

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