Alan’s entry into the world of sterilization
Alan G Heavey
Authorising Engineer (Decontamination), previously named Authorised Person (Sterilizers)
Consultant Sterilizing Engineer
I’ve been involved for 34 years in the field of sterilization within the Pharmaceutical, Biotech and Healthcare industries.  During this time period I have specialised in moist heat sterilization; stumbling into it many years ago, almost by accident.  As an engineer first getting involved in this field a long time ago, ‘the autoclave and sterilization process’ fascinated me.
Although at the time I knew very little about this subject, my background had been in steam, pneumatics, hydraulics, fluidics, controls and a cross-platform of mechanical engineering.  Back in those early days I had recently joined the National Health Service (NHS) in England, where I was given responsibility to look after these ‘things’ called autoclaves.  As I got heavily involved I became ‘hungry’ to know more.  It became increasingly clear to me that not many others had the same interest as me, but no matter.  I would shadow the contract service and commissioning technicians to learn as much as I could from them; although it became abundantly clear that their knowledge of the sterilization process, even on their own equipment was limited.  So over the next few years I purposed to learn (at many times lying on my back underneath these, at times, complex pieces of equipment), and determined to understand as much as I could.
Over the next 9 years in the NHS, through my time in the Area and then Regional Authorities, I learnt a lot about the moist heat, dry heat, depyrogenation, low temperature steam and formaldehyde processes etc. before moving into the Pharmaceutical and Biotech industry.  
I was registered by the Institute of Healthcare Engineering and Estate Management (IHEEM) as an ‘Authorised Person (Sterilizers)’ in May 1995.  This AP(S) registration was formally reviewed and approved in April 2000, and again in December 2005.
The Pharmaceutical and Biotech industry has long recognised the AP(S) as an expert professional in the field of sterilization.  Unfortunately the name has now changed!  On the 1st July 2008, IHEEM migrated the register for all ‘Authorised Persons (Sterilisation)’, which it has maintained on behalf of the Department of Health in the UK since 1996, to the new ‘Authorising Engineer (Decontamination) Register.  Apparently the new ‘Authorising Engineer’ role has meant that some changes to the Register have been made to reflect the Health Technical Memorandums (HTMs) and their equivalent guidance.  For me personally it is a source of confusion for the Pharma and Biotech industry.  However that’s how it is; I still offer the same professional service as I did prior to this name change – for more information on this please visit; IHEEM
An engineer by profession, I have experience in most areas of sterilization technology and its application, from system and equipment design, through to qualification, maintenance, troubleshooting and management of operational, validation and qualification activities.  I provide consultancy advice, audits, system reviews, training courses and technical support for autoclaves, SIP systems and dry heat/depyrogenation systems.
Based in the UK, I travel worldwide in my capacity to assist companies with their specific needs.  The uniqueness of my experience enables me to advise in many areas, including assistance with the expectations of regulatory bodies.
I have run my own business since 1989, becoming established internationally in consulting, lecturing and training roles, working for organisations in the United Kingdom, Ireland, mainland Europe, the Middle East, South Africa and the United States of America.
Although being an independent consultant, I have an association with the pharmaceutical consultants, ‘David Begg Associates’ of York – now operating as NSF Health Sciences.  I have had the pleasure of working with DBA for many years now; assisting them with training, lecturing and consulting activities.
As well as being involved with sterilizers, I have also worked in different areas within the industry, e.g. the sterilization of Freeze Driers and monitoring of temperature/humidity sensitive environments, Stability Rooms, incubators, cold storage areas, warehouses etc.
In order to keep up to date with developments in these areas, I have attended various technical training courses, including the AE (D) meetings and technical seminars.  I am also on the Management Committee of the Pharmaceutical and Healthcare Sciences Society (PHSS) and a member of the Parenteral Drug Association (PDA), and the International Society for Pharmaceutical Engineering (ISPE).
About Alan