Presented by
Management Forum
An Introduction to Ethylene Oxide (EO) Sterilization for Medical Devices Training Course
An Essential Overview
Sterile devices are free of viable microorganisms and EO sterilization is one of the key processes in the production of sterile medical devices. This course provides an introduction to the regulatory requirements as they relate to EO sterilisation and how manufacturers may demonstrate compliance.
21 November 2023
from £299
- Format: Live online
- CPD: 3 hours for your records
- Certificate of completion
- Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations
- 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 EO 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 by Ethylene Oxide 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;
- Determining whether the sterilization process has any adverse effect on the devices; and
- Maintaining sterility over time with appropriate sterile barrier systems
This course provides an introduction to these regulatory requirements as they relate to EO sterilization and how manufacturers may demonstrate compliance.
This course is part of our GxP (Good x Practice) training course collection, which feature a variety of topic areas to ensure you comply with the regulations and quality guidelines.
Benefits in Attending
- Gain an overview of medical device sterilization by EO
- Understand the principles of EO validation for medical devices
- Learn the regulatory requirements for EO sterilization and how to comply
- Gain an awareness 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 a copy of ISO 11135 to gain the most from this training. If you do not already have access to this through your organisation, please see below the ways to acquire it:
ISO 11135 - https://www.iso.org/standard/56137.html
This standard is also available from national standards organizations such as BSI, DIN, AFNOR, AAMI, NSAI, etc
The An Introduction to Ethylene Oxide (EO) Sterilization for Medical Devices course will cover:
Ethylene Oxide Sterilisation Principles
- Background and the ISO 11135 standard
- Microbiocidal principles of ETO
- ETO sterilisation process stages and critical parameters
- Product characteristics affecting / affected by ETO
Validation of Ethylene Oxide Sterilisation Installation and Operational Qualification (IQ & OQ)
- Microbiological performance qualification (MPQ)
- Use of biological and chemical indicators
- Physical performance qualification (PPQ)
- Product adoption into existing validations – ISO 11135 and AAMI TIR 28
Routine Monitoring and Control
- Product release from sterilisation
- Assessment of change and revalidation
- Bioburden monitoring and ISO 11737-1
Ethylene Oxide Residual Control and Testing
- Establishing limits – ISO 10993-7
- Testing process and considerations
- Product release considerations
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).
Book An Introduction to Ethylene Oxide (EO) Sterilization for Medical Devices Live online training
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
21 November 2023
Live online
13:30-17:00 UK (London) (UTC+00)
14:30-18:00 Paris (UTC+01)
08:30-12:00 New York (UTC-05)
Course code 14234
- GBP 299 349
- EUR 429 499
- USD 501 579
Until 17 Oct
- 3 hours of live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
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.
