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Sterilization of Medical Devices Training Course

A comprehensive introduction

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.

★★★★★ "Very structured training at perfect pace, covering all important point. Very good interaction."

6-7 June 2024
+ 17-18 October 2024 »

from £1099

Need help?  Enrol or reserve

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.

This course is part of our GxP training (Good x Practice) course collection, which features a variety of topic areas to ensure you comply with the most recent quality guidelines. For more information on the latest EU GMP regulations, see our GMP training course covering the Annex 1.

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

Please note that delegates will require access to copies of ISO 11135 and ISO 11137-1 in order to take part in the exercises. If you do not already have access to these through your organisation, please see below the ways to acquire them:

ISO 11135 - https://www.iso.org/standard/56137.html

ISO 11137-1 - https://www.iso.org/standard/33952.html and amendment at https://www.iso.org/standard/72106.html

These standards are also available from national standards organizations such as BSI, DIN, AFNOR, AAMI, NSAI, etc.

Enrol or reserve

The Sterilization of Medical Devices course will cover:

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

Enrol or reserve

Annette Callaghan
Sterile Management Systems

More details

NEW higher discounts for multiple bookings - 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*

Please contact us for pricing if you are interested in booking 5 or more delegates

6-7 June 2024

Live online

09:30-17:30 UK (London) (UTC+01)
10:30-18:30 Paris (UTC+02)
04:30-12:30 New York (UTC-04)
Course code 14184

  • GBP 1,099 1,299
  • EUR 1,589 1,869
  • USD 1,817 2,129

Until 02 May

View basket 

 
Not ready to book yet?

for 7 days, no obligation

17-18 October 2024

Live online

09:30-17:30 UK (London) (UTC+01)
10:30-18:30 Paris (UTC+02)
04:30-12:30 New York (UTC-04)
Course code 14185

  • GBP 1,099 1,299
  • EUR 1,589 1,869
  • USD 1,817 2,129

Until 12 Sep

View basket 

 
Not ready to book yet?

for 7 days, no obligation

* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price.

Reviews of IPI's Sterilization of Medical Devices training course


Very structured training at perfect pace, covering all important point. Very good interaction.

Jun 1 2023

Marijana Jelecevic Kakouros
RA Manager, Beckton Dickinson

Oct 19 2023

Training materials were detailed and easy to follow. Trainer was engaged and made sure that contents were delivered in a way that the Trainees could relate to.

Esther Okeudo
QA Specialist, JenaValve

Jun 1 2023

An excellent webinar that delivered above and beyond. Eamonn would be a great contact to keep for the future. His knowledge is top class.

Kerry Poole
Mercian Surgical Co Ltd

Sweden

  • Bactiguard AB
  • Oticon Medical
  • Oticon Medical AB

Finland

  • Icare Finland Oy
  • Innokas Medical

France

  • BD
  • Beckton Dickinson

United Kingdom

  • JenaValve
  • Mercian Surgical Co Ltd

Belgium

  • Nikkiso Belgium

Brazil

  • Ul Solutions

Canada

  • SterileCare Inc.

Ireland

  • SymPhysis Medical

Liechtenstein

  • Ivoclar Vivadent AG

Poland

  • Paul Hartmann Manufacturing Sp. z o.o.

Switzerland

  • Gerresheimer

United States of America

  • QIAGEN Sciences LLC

Enrol or reserve

Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra Beer

Aleksandra BEER
Training expert

Yesim Nurko

Yesim NURKO
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy