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EU Sterilization Explained

With the masses of regulations and standards in the US and Europe, knowing exactly which standards to follow can be confusing. That is why we have a developed this course which provides a detailed insight into how to satisfy all the EU requirements for moist heat sterilization.

Topics include:

  • History & Regulatory background
  • Cycle design criteria
  • Equilibration times and other measures
  • Bowie Dick/DART tests – theory and practice
  • Steam quality and steam quality testing
  • Leak rate tests and test specifications
  • Test frequency’s
  • Load configurations for validation/revalidation
  • Choice of biological indicators
  • Long hold times
  • Air detector’s

After completion of the masterclass, delegates receive comprehensive notes and Certificates of Attendance. Formal assessments and certification of competence are also available on request.

The EU Sterilization Explained info pack can be downloaded here


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Your Tutor

Keith Shuttleworth is the Senior Consultant at KS & A, which provides a range of specialist products, consultancy and training services associated with sterilization processes and steam quality testing to an international market. He has some 25 years practical experience in the procurement, commissioning, validation and maintenance of sterilizers.

Keith was registered as an Authorised Person (Sterilizers) in October 1994 and is currently a member of the British Standards Institute Committee CH/198 (Sterilization of Medical Devices), is Chair of the P & HSS Sterilization Special Interest Group and has been a member of the PDA Task forces for Sterilizer Validation and SIP Technical Reports.

Keith has provided a wide range of presentations for ISPE, PDA and P&HSS, in addition to providing numerous in house training sessions throughout the world (including the UK’s MRHA Inspectors).