COURSE OVERVIEW

Ethylene Oxide Sterilization

Ethylene oxide (often referred to as EO or EtO) is a widely used low-temperature gaseous process used to sterilize a variety of healthcare products, such as single-use medical devices. As regulatory requirements become increasingly complex, this course will help you navigate them with ease.

This training offers you the chance to gain theoretical knowledge, as well as applying your new-found skills in a practical manner. You can expect to gain a deeper understanding of the guiding principles and processes around EO Sterilization, including process definition, adoption and optimization.

Course Information

Course Syllabus 

Course Agenda

This training course is broken down into topics to enhance clarity and facilitate learning. Here's what you can expect:

Part 1:                                                     
- Introductory microbiology for sterilization
- Bioburden determination
- Bioburden exercise
- Bioburden exercise feedback

Part 2:                                
- Microbial inactivation
- Biological indicators
- Introduction to EN ISO 11135
- Background to ethylene oxide sterilization
- Q&A

Learning Objectives

  • Gain an understanding of the principles and practical application of ethylene oxide sterilization
  • Be familiar with the structure and requirements of the international standard 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

Who Should Attend? 

This course is recommended for those in the medical device industry who are interested in ethylene oxide sterilization. This includes:
  • Microbiologists and sterilization professionals
  • Quality Management System (QMS) specialists
  • Regulatory Compliance specialists
  • Internal Auditors
  • Regulatory and Quality professionals

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