Management Forum courses now available at IPI Academy - visit IPI for an updated experience and a broader selection of courses and subjects

Sterilization of Medical Devices Training Course

Sterile devices are free of viable microorganisms and sterilization is one of the key processes in the production of sterile medical devices. Regulations for medical devices include particular requirements for devices supplied or intended to be used in a sterile state. These regulatory requirements relate to general safety and performance aspects for the products, and the requirements for independent, third-party conformity assessment of the processes for achieving sterility. Evidence of successful sterilization is important and expected when demonstrating conformity with the regulations. This course provides a comprehensive overview of these regulatory requirements and how to comply, together with the science and standards that support them.

20-21 Oct 2022

& 2-3 Feb 2023 , 1-2 Jun 2023

Book now

Details

Overview

Sterile devices are free of viable microorganisms and sterilization is one of the key processes in the production of sterile medical devices. Regulations for medical devices include particular requirements for devices supplied or intended to be used in a sterile state. These regulatory requirements relate to general safety and performance aspects for the products, and the requirements for independent, third-party conformity assessment of the processes for achieving sterility. Evidence of successful sterilization is important and expected when demonstrating conformity with the regulations. 

These requirements have been supported by a portfolio of standards on:

  • Designating products as sterile;
  • Validating and routinely controlling the sterilization process; and
  • Maintaining sterility over time with appropriate sterile barrier systems

This course provides a comprehensive overview of these regulatory requirements and how to comply, together with the science and standards that support them.

Benefits in attending

  • Gain a comprehensive overview of medical device sterilization
  • Recognise the principles of the commonly applied methods of sterilization
  • Learn the regulatory requirements for sterilization and how to comply
  • Understand the portfolio of supporting standards and their interrelationships

Who should attend

  • Microbiologists and sterilization professionals
  • Quality Management System (QMS) specialists
  • Regulatory Compliance specialists
  • Internal Auditors
  • Regulatory and Quality professionals

Programme

Introduction and welcome

The use of standards and overview of standards for sterilization

  • Role of standards
  • Interaction of standards and regulations for medical devices
  • Portfolio of sterilization standards

General requirements

  • ISO 14937 - Sterilization of health care products – General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
  • Structure of sterilization standards
  • Common features of validation and routine control

Microbiology quality

  • Introduction to microbiology
  • Sources of microbial contamination
  • Contamination control

Microbiology methods

  • Bioburden estimation – EN ISO 11737-1 Sterilization of medical devices – Microbiological methods - Part 1: Determination of a population of microorganisms on products
  • Test of sterility – EN ISO 11737-2 Sterilization of medical devices – Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process

Microbial inactivation

  • Inactivation kinetics
  • Sterility assurance
  • EN 556-1 Sterilization of medical devices – Requirements for a terminally-sterilized device to be labelled “Sterile”

Sterilization by irradiation

  • Nature of ionizing radiation
  • Sources of ionizing radiation
  • Measurement of radiation dose
  • Installation Qualification, Operational Qualification and Performance Qualification
  • EN ISO 11137-1 1 Sterilization of health care products - Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
  • EN ISO 11137-3 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control
  • EN ISO 11137-4 Sterilization of health care products — Radiation — Part 4: Guidance on process control

Q & A

Introduction and recap of day one

Sterilization by irradiation (cont.)

  • Establishing the sterilization dose
  • EN ISO 11137-2 Sterilization of health care products - Radiation – Part 2: Establishing the sterilization dose
  • ISO/TS 13004 Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD

Biological indicators

  • EN ISO 11138 series - Sterilization of health care products — Biological indicators

Syndicate exercise - Radiation sterilization

  • Feedback and discussion 

Ethylene oxide sterilization

  • EN ISO 11135 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices

Ethylene oxide sterilizaton (cont.)

  • EN ISO 11135 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices

Syndicate exercise - Ethylene oxide sterilization

  • Feedback and discussion 

Moist heat sterilization

  • EN ISO 17665-1 Sterilization of health care products - Moist heat – Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices

Wrap up and Q & A

Presenter

Eamonn Hoxey (More...)

Eamonn Hoxey, is a technical author, trainer and consultant in life science areas including regulatory compliance, quality management, sterility assurance and standards development. Eamonn worked for Johnson & Johnson for 17 years in positions of increasing responsibility for Quality and Regulatory including Vice President of Compliance for J&J’s medical devices companies. Prior to joining J&J, Eamonn spent 16 years with the UK Medical Devices Agency, including six years as Head of Device Technology and Safety.

Eamonn is past chair of ISO TC 210 ‘Quality management and related general aspects for medical devices’ and ISO TC 198, ‘Sterilization of Healthcare products’. He is past chair of the Board of Directors of AAMI.

Dr Hoxey graduated as a Bachelor of Pharmacy and has a Ph.D. in Pharmaceutical Microbiology from the University of Bath. He was designated a Fellow of the Royal Pharmaceutical Society of Great Britain in 2004. He received the BSI Wolfe-Barry medal in 2016 for his contribution to standards development.

 


Book now

Book now

NEW higher discounts for booking multiple places - bring your colleagues to make your training budget go further:

  • 30% off the 2nd delegate
  • 40% off the 3rd delegate
  • 50% off the 4th delegate
20-21 Oct 2022
Live webinar
09:30-17:30
UK (London)
20-21 Oct 2022
Live webinar
09:30-17:30
UK (London)
GBP 1,299 1,099
EUR 1,859 1,579
USD 2,098 1,786
Until 15 Sep*
Enrol now
to attend
Live webinar
2-3 Feb 2023
Face-to-face, (venue not yet confirmed)
09:00-17:30
UK (London)
2-3 Feb 2023
Face-to-face
(venue not yet confirmed)
09:00-17:30
UK (London)
GBP 1,499 1,299
EUR 2,099 1,819
USD 2,338 2,026
Until 29 Dec*
Enrol now
to attend
Face-to-face
(venue not yet confirmed)
  • 2 days classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy
1-2 Jun 2023
Live webinar
09:30-17:30
UK (London)
1-2 Jun 2023
Live webinar
09:30-17:30
UK (London)
GBP 1,299 1,099
EUR 1,859 1,579
USD 2,098 1,786
Until 27 Apr 23*
Enrol now
to attend
Live webinar

Learn more about our face-to-face and webinar training formats.

* Note the early booking discount cannot be combined with any other offers or promotional code. As such, discounts for the 2nd/3rd/4th attendees are based on the full price of the course. Please contact us for pricing if you wish to send more than 4 delegates.

Continuing professional development

This course qualifies for 12 hours for your CPD records.
More about CPD

Customised in-house training

We can customise this course to meet the requirements of your organisation and deliver it at your location and/or online.

Contact us