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Gordon Farquharson will give two presentations at Tema Renrum 2023 – Read more about the presentations below
Principal of Critical Systems Ltd
Gordon Farquharson, B.Sc. (Hons), C.Eng. is a Chartered Consulting Engineer with more than 40 years’ experience of quality & safety critical processes and facilities used by industries such as Healthcare, Life Science, Micro-electronics, etc. He is Principal consultant and Managing Director of Critical Systems Ltd, an international consultancy firm. In the Asian and ASEAN regions, he also provides consultancy services in association with Airex (Japan), Pharma solutions (Japan), FactoryTalk (Thailand), CM-Plus (Japan & Vietnam), Tofflon (China) and PharmOut (Australia).
In recent years Gordon has focused on technologies such as isolators, barrier technology, mini-environments, critical utility systems and bio-containment applications. He has been responsible for the development of technical solutions in product development, primary manufacturing and device and dosage form manufacturing.
Standards and regulatory compliance issues in the Pharma/Life Science sectors are a major interest and responsibility. In this context he has a high degree of expertise in the practical interpretation & application of EU/PIC-S/WHO GMPs and US FDA cGMP requirements. In recent years, he has been heavily involved in the development of the new regulatory guidance and standards. In particular, he is active working on CEN/ISO Cleanroom & Contamination Control Standards, WHO GMP guidance and ISPE Baseline Guides. He is Chairman of BSI’s LBI 30 Committee and of CEN Technical Committee 243 and is a UK expert working on the ISO TC209 and CEN TC243 family of contamination control standards that provide the platform for contamination control standardisation and practice. He has provided technical guidance and input into the cleanroom classification and monitoring requirements in the 2008 & 2022 version of Annex 1 of the EU and PIC/S GMPs and has contributed writing WHO’s Pharmaceutical water GMP Guidance.
He is a founding member, management committee member, past Chairman, and Honorary Member of the UK Pharmaceutical & Healthcare Sciences Society (PHSS) (formerly Parenteral Society), and is President of the Contamination Control Network, an international not for profit society based in the UK. He is a past chair of the ISPE European Education Committee and was voted ISPE International Member of the year 2001, UK Affiliate Member of the year in 2008, and recipient of the Richard B Purdy Distinguished Achievement Award 2009. He has been a member of the PDA Science Advisory Board (SAB). In the academic world, he is an honorary senior lecturer at UCL (London) and the University of Manchester PEAT, PIAT & PMAT programmes.
He lectures and teaches extensively, is an author of articles and papers, and contributor to books on engineering and technology applications in the in the field of environmental control and contamination control.
Gordon Farquharson’s Presentation no. 1 (of 2)
Annex 1 2022 Issues and Solutions
This presentation will focus on the errors, lack of clarity and confusions related to “cleanroom and associated controlled environments”, their specification, testing and monitoring.
Our industries we should be debating product quality, not spending so much time and effort discussing interpretation of regulatory requirements. Much of the science and background, will have been debated in the PHSS SIG and ISO TC209 tech report working groups.
The issues I plan to cover are:
- Fundamental issue with the weight given to 5 micron and greater particles considerations. Are they really important?
- The 1 m sample tube length confusion.
- Better understanding of measurement uncertainty (sampling efficiency) when using LSAPCs.
- Issues of isokinetic sampling error.
- Developing a sensible specification for unidirectional airflow systems (UDAF systems) including velocity and airflow visualisation.
Gordon Farquharson’s Presentation no. 2 (of 2)
Net-Zero Carbon 2050 & Energy Reduction for Cleanrooms and Associated processes – Opportunities, standards/guidance and GMP risks
- The 2050 aspirations.
- ISO energy management standards ISO 50001:2018; ISO 14644-16:2019 and ISO 14644-4:2022.
- Energy profile for typical pharmaceutical manufacturing operations.
- Energy saving opportunities – for new & legacy facilities, including some important risks.
- Making a plan.
- Implementing energy reduction and monitoring outcomes.