Introduction to Ethylene Oxide (EtO) for Medical Devices

SOCSO Course Category: Manufacturing

SOCSO Course Code: HIT3044

Course Title: Introduction to Ethylene Oxide (EtO) Sterilization for Medical Devices

Duration:1 Day

Target Group: Quality and regulatory affairs managers, engineers, technicians involved in the development, manufacturing and packaging of medical devices

Target Industry: Medical Device Manufacturing Industry

Certification: Certificate of Attendance in Introduction to Ethylene Oxide (EtO) Sterilization for Medical Devices by the Association of Malaysian Medical Industries

Course Objectives:

Medical device manufacturing is both demanding and complex. The training course is designed to create better understanding of the Ethylene Oxide (EtO) sterilization process for the medical device manufacturing professionals in Malaysia.

 

Methods/ Methodology:

  • Lecture
  • Case Studies
  • Pre-Test & Post-Test

 

Course Content:

  1. Introduction to EtO Sterilization
  2. Comparison of EtO to other sterilization methods
  3. Introduction to Microorganism(s)
  4. Sterilization Process, Media & Equipment
  5. Validation of EO Sterilization Process
  6. Understanding on Sterility Assurance Level
  7. EO Residual Requirements

 

Learning Outcomes

Upon successful completion of the training, participants will have an in depth perspective and practical examples of the EtO sterilization process, such as validation & standard, EtO routine process control, EtO residuals, safety & environmental control, handling EtO gas and biological indicator.