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.
- Tim Coles & Dr Helen Hale Article – Taming the Tyrannosaurus of Validation - 6th February 2018
- Exclusive ISPE Decontamination & Validation ½ Day Workshop and Focus Group - 18th January 2018
- The Shortfalls Of Biological Indicators For HPV Decontamination Validation - 7th September 2017
- Protak Features In Clean Air & Containment Review - 1st August 2017
- Protak Scientific At Pharma Integrates 2017 In November As Sponsor & Panelist - 1st July 2017
- Enzyme Indicators Proven As Viable Alternative For HPV Decontamination Validation - 20th June 2017
- Protak Scientific At The ISPE UK Summer Conference: Containment & Decontamination – 14/6 - 6th June 2017
- Howorth Air Technology Trials Enzyme Indicators Successfully - 26th May 2017
- Clean Air & Containment Review – “EI’s Will Eventually Take Over BI’s” - 5th May 2017
- Protak Scientific Announce Appointment of Netsteril As Distributor for Spain To Supply Revolutionary Alternative To Biological Indicators - 15th February 2017