Validation and Routine Control of Sterilization Processes in the Manufacture of Sterile Medical Devices

About this course

This two-day course is intended to provide an introduction to the validation and routine control of the common sterilization processes that may be used in manufacture of sterile medical devices, including how to satisfy current regulatory expectations.

What You Will Learn

• An introduction to sterilization kinetics and the concept of SAL
• General principles related to the validation and routine control of irradiation, ethylene oxide, steam and dry heat sterilization processes
• How current standards are applied to the validation and routine control of sterilization processes
• When and how to use biological and chemical indicators correctly
• The use of risk management processes in managing sterilization
• Factors to consider when selecting a sterilization process
• The role and responsibilities of the manufacturer and a sterilization subcontractor

Who Should Attend

The course is designed for Development Engineers, Manufacturing Engineers, Validation Engineers, Quality Assurance and Regulatory personnel involved in the design, validation and routine control of sterilization processes used during the manufacture of sterile medical devices.

This course forms part of the ‘Managing Cleanrooms & Sterile Medical Device Products’ suite

Enjoy a discount by attending more than one course in this suite. Please contact our team at NSF-DBA for further details

Course outline

• The concept of sterility and the definition of Sterility Assurance Levels (SAL)
• Regulatory and quality system requirements related to sterilization and examples of sterilization-related quality system failures
• An introduction to the validation and routine control of the main sterilization processes (ie ethylene oxide, irradiation, moist heat and dry heat)
• Other sterilization processes, including requirements for the characterisation of a sterilizing agent and the development, validation and routine control of the process
• Microbiological methods associated with validation and control of sterilization processes (including bioburden determination and tests of sterility)
• The use (and misuse) of biological and chemical indicators
• Managing the use of a sterilization subcontractor

This course forms part of the ‘Managing Cleanrooms & Sterile Medical Device Products’ suite

Venue

AMP Technology Centre, Sheffield, UK & 'In House' company course available

We have selected the Advanced Manufacturing Park (AMP) Technology Centre near Sheffield as its location and environment are ideal to centralise and control our services. Based in a region well known for its expertise in healthcare manufacturing technologies and supported by clinical and academic excellence, the Centre provides an ideal location for business events, meetings, seminars, training events and small scale trade shows. With free parking, proximity to the M1 and M18, and within an hour’s drive of Leeds, Manchester, Sheffield, Bradford, Nottingham and Leicester, it is a convenient and accessible location.

The AMP has been designed to accommodate a range of manufacturing related activities, from the work of fledgling engineering and technology companies to the University of Sheffield’s collaboration with some of the world’s foremost advanced manufacturing technology businesses, such as Boeing and Rolls Royce.

Hotel Accommodation

We have a block booking of bedrooms at both the Aston Hotel Sheffield and the Holiday Inn Rotherham-Sheffield at a specially negotiated bed and breakfast rate. Hotel reservations should be made directly with the hotel. Please quote ‘NSF’ at the time of booking.

Any charges made by the hotel as a result of you not taking up your reservation for any reason will remain your responsibility, therefore please ensure that you are aware of the hotel’s cancellation policy.

Aston Hotel Sheffield, to book please call the hotel on +44 (0) 1142 615690, quoting ‘NSF’.

Holiday Inn Rotherham-Sheffield, to book please call the hotel on +44 (0) 1709 830630, quoting ‘NSF’.

Venue Address and Contact Details

AMP Technology Centre
Advanced Manufacturing Park
Brunel Way
Rotherham
S60 5WG
England

Tel: +44 (0)114 254 1200
Fax: +44 (0)114 254 1201

Tutors

We believe that our team of experts are the best available. Not only have they got years of experience in the industry, but they are committed to tutoring and helping those inside the industry to improve and raise the standards. We understand that you attend courses to learn about the latest regulations and to get your questions answered.

Our experts for this course are:

• 

  Simon Richards
  NSF-DBA Medical Devices Consultant
  

  • [email protected]
  • +44 (0) 1143 600868

What you've said

“Very good overview of the sterilisation process. Went into a good level of detail of specific procedures in discussion with delegates.”

“EtO was the best part for me as I found that this helped me understand about the processes/SAL & microbiological determination. Overall good session”