Presented by
Management Forum
Sterilization of Medical Devices In-house Training
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.
★★★★★ "[Speaker] very experienced, knowledgeable and approachable. Webinar [was] prepared taking into accou... more"
- Format: Live online
- CPD: 12 hours for your records
- Certificate of completion
- UK Conformity Assessed (UKCA) Marking for Medical Devices
- Sterilization of Medical Devices
- An Introduction to Ethylene Oxide (EO) Sterilization for Medical Devices
- Unique Device Identification (UDI) and Labelling for Medical Device Manufacturers
- Non-Conformance and Corrective Action for Medical Device Manufacturers
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.
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.
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 of 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
This course will cover:
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
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
Annette Callaghan
Sterile Management Systems
A quality management professional, chartered biologist and member of the Royal Society of Biology, with over 35 years’ experience in the medical device, pharmaceutical, biotechnology and food industries. Extensive knowledge of quality and environmental management systems, internal and third-party auditing and personnel training. Eligible to act as a Qualified Person as defined in Directive 2001/83/EC, as amended (previously 75/319 et al.) since 1993. A Qualified Notified Body Lead Auditor since 2002 (IRCA ref: 1182641).
Reviews of IPI's Sterilization of Medical Devices training course
[Speaker] very experienced, knowledgeable and approachable. Webinar [was] prepared taking into account all of the participants with the general information as well as with the direct individual requirements in mind. Questions answered at the time as well as within time given after the webinar. Thank you.
Oct 17 2024
Dorota Seweryn 
Quality Engineer, First Water Ramsbury Limited
Jun 6 2024
The Speaker was very knowledgeable and the inside stories are great!
Priya Woodun
Senior QA Compliance Officer, Endomagnetics Ltd
Jun 1 2023
Very structured training at perfect pace, covering all important point. Very good interaction.
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
United Kingdom
- Endomagnetics Ltd
- Endomagnetics Ltd.
- First Water Ramsbury Limited
- Gentell
- JenaValve
- Mercian Surgical Co Ltd
Sweden
- Bactiguard AB
- Oticon Medical
- Oticon Medical AB
Finland
- Icare Finland Oy
- Innokas Medical
France
- BD
- Beckton Dickinson
Switzerland
- Gerresheimer
- Tecan
Belgium
- Nikkiso Belgium
Brazil
- Ul Solutions
Canada
- SterileCare Inc.
Greece
- EKAPTY SA
Ireland
- SymPhysis Medical
Liechtenstein
- Ivoclar Vivadent AG
Norway
- Norwegian Medical Products Agency
Poland
- Paul Hartmann Manufacturing Sp. z o.o.
Thailand
- UNFPA
United States of America
- QIAGEN Sciences LLC
Run Sterilization of Medical Devices Live online for your team
2 days
Typical duration
Pricing from:
- GBP 800
- Per attendee, based on 10 attendees
- Course tailored to your requirements
- At your choice of location, or online
We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.
Contact our in-house training experts Aleksandra Beer and Yesim Nurko to discuss your requirements:
