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Understanding Ethylene Oxide Sterilisation for Medical Devices

1 December 2022 | Short Online Course

£236.00£295.00

1 day live online training | Starts 10 AM UK Time

Master ethylene oxide sterilisation for your devices with this 1-day course – Click Here to Download the Agenda

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Course Overview

 

Many medical devices must be sterilised to ensure they are safe for the patient. One of the most popular methods to sterilise a device is using ethylene oxide. Manufacturers using Ethylene Oxide Sterilisation (EOS) on their devices need to comply with international regulations and standards such as ISO 11135:2014, AAMI TIR28:2016 and ISO 10993-7:2008+AMD1:2019.

 

This short live online course will provide you an in-depth insight into EOS process, validation and monitoring. You will examine important standards ISO 11135:2014, AAMI TIR28:2016, ISO 10993-7:2008+AMD1:2019 that you must comply with when using EO as a sterilisation method. Once completed, you will have the knowledge and confidence to oversee of ethylene oxide sterilisation for your products. Learn more about how we deliver live online training

Key Learning Objectives

 

  • Examine the relevant standards for ethylene oxide sterilisation so your products are compliant
  • Fully understand the fundamentals of EOS such as process stages and critical parameters
  • Learn to perform various qualification steps to ensure your EOS process is fully validated
  • Examine how to monitor and control products to ensure they
  • Discover best practice for ethylene oxide residual control and testing
What is Included?
  • Direct access to an expert trainer
  • Interactive and engaging sessions
  • Access to the Educo Life Sciences Training Portal
  • Unlimited access to the recordings for 2 weeks after the session
Download the Agenda

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Course Information

Course Information

  • The course begins at the time stated at the top of the page
  • The course is broken up into modules outlined below
  • There will be breaks between modules
Session 1

1 December | 120 mins | 10:00 AM UK

Throughout the course you will examine in-depth the requirements of ISO 11135:2014, AAMI TIR28:2016 and ISO 10993-7:2008+AMD1:2019. You will also touch upon ISO 11138 parts 1,2 & 7 and ISO 11737 parts 1 & 2.

 

Ethylene oxide sterilisation principles

  • 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)
  • Physical performance qualification (PPQ)
  • Product adoption into existing validations
Session 2

1 December | 120 mins | 1:00 PM UK

Throughout the course you will examine in-depth the requirements of ISO 11135:2014, AAMI TIR28:2016 and ISO 10993-7:2008+AMD1:2019. You will also touch upon ISO 11138 parts 1,2 & 7 and ISO 11737 parts 1 & 2.

 

Routine monitoring and control

  • Product release from sterilisation
  • Assessment of change and revalidation
  • Bioburden monitoring

 

Ethylene oxide residual control and testing

  • Establishing limits
  • Testing process and considerations
  • Product release considerations

Jack Walters academic and industry research background is well suited to sterilisation and the associated technologies, having covered material science and engineering through to microbiology and toxicology. He was formally a member of BSI, CEN and ISO committees for sterilisation of healthcare products, as well as a subject matter expert on disinfection, packaging and sterilisation at a leading notified body. For the past number of years however he has focussed on provision of auditing, training and consultancy services via his own company founded in 2017 and selected partners, and remains an active member of a number of committees such as at the Institute of Decontamination Sciences as a member of the education committee.

This short live online course is suitable for professionals involved with ethylene oxide sterilisation and includes:

  • Quality assurance
  • Regulatory affairs
  • Production managers
  • Engineers
  • Supply chain managers
  • Internal auditors
  • Packaging and environmental engineering
e-learning options

Want to train your team, department or whole organisation? This course can be developed into on-demand e-learning and hosted by Educo Life Sciences or on your own LMS platform.

Email [email protected] for more information.

Could your team benefit from this course?

We can customise this course to meet the requirements of your organisation, delivered as a classroom and/or online course.

For more information you can email us at [email protected] or call +44 (0) 203 111 7357.

 

Complete our contact form by following the link. Get in touch.

*

• This course is delivered online
• For live online courses, module durations are approximate
• You will have full access to the training portal and the recordings for 2 weeks after the training