MODULE 6

QUALIFICATION OF FACILITIES, UTILITIES, AND EQUIPMENT: WATER SYSTEMS, HVAC, COMPRESSED AIR BMS

Aims

The aims / objectives of this module are to provide the student with an understanding of:· 

• facility validation.
• the validation requirements for HVAC (Heating, Ventilation and Air Conditioning) systems.·
• the validation requirements for pharmaceutical water systems.
• the validation requirements for product contact compressed air systems.

Learning outcomes

On completion of this module the student should be able to:

• describe the principles of facility design.
• set acceptance criteria for pharmaceutical facilities and utilities.
• prepare validation protocols for pharmaceutical facilities and utilities.

Tutor Information

Dr John Hutcheson  C.Chem., MRSC

• Currently Pharmaceutical and Life Sciences Business Unit Manager, Christ Water Technologies and UK/Ireland General manager.
• PhD in organic synthetic chemistry followed by 3 years working in down stream processing at Beecham Pharmaceuticals.
• 2 years as Senior Research Chemist at Scottish and Newcastle Breweries.
• 5 years designing and selling water systems, filtration systems, chromatography and microbiological monitoring systems for Millipore.
• Founding member of Ionpure Technologies Ltd. This company became the leading supplier of Purified Water systems in the UK over a 5 year period.
• 10 years working in Ionpure, then USF Ionpure, then USF Ionpure Permutit (ultimately as General Manager) prior to managing a European Pharmaceutical Technology and Marketing Group for USF.
• 2 years working as Operations Manager for BioKinetics, world leading engineering and high purity piping company.
• Author of a number of papers on aspects of water purification and speaker at a number of conferences on water purification. Lecturer at Cranfield University and Brighton University in addition to presenting on other training courses on water treatment, particularly David Begg Associates courses.