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 director of Hutch2O Limited, a company providing training, trouble shooting and technical support services for Pharmaceutical water systems.
  • PhD in organic synthetic chemistry followed working in down stream processing at Beecham Pharmaceuticals.
    Senior Research Chemist at Scottish and Newcastle Breweries.
  • Sales and design of water systems, filtration systems, chromatography and microbiological monitoring systems for Millipore.
  • Founding member of Ionpure Technologies Ltd. and 10 years working in 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.
  • 4 years with the Christ group as Pharmaceutical Global market manager and UK & Ireland Sales Manager
  • Author of papers on water purification and speaker at technical conferences.  Lecturer at Cranfield University, University of Manchester and Brighton university in addition to presenting on other training courses on water treatment, particularly with David Begg Assocaites.