Sterilization by EO

EO sterilization of medical devices

This course - Sterilization by EO - is designed to provide participants with an understanding of the EN ISO 11135 requirements for sterile medical devices and compliance with MDR .

This 1 day training provides an in depth knowledge of the EN ISO 1135 requirements and study cases.  Medical Device Software & Sterilization Professionals provide the course worldwide from our Lee-on-the-Solent, Hampshire base.

Learning objectives / course outcomes

On completion of this training, participants will be able to :

  • Identify the links between MDR and EN ISO 11135
  • Define the requirements for the validation of sterilization
  • Define the type of indicator used and its compliance with ISO 11138
  • Define the requirements for the sterilization in routine and the release of batches
  • Identify the content of a validation report of sterilization

Intended audience

  • Regulatory, quality assurance managers and personnel
  • Design and development managers and personnel
  • Quality control personnel

Content of the course

  • I- Introduction
  • II- Characterisation of the device’s material and interaction with ethylene oxide
  • III- What type of indicator to use
  • IV- Validation- IQ
  • V- Validation- OQ
  • VI- Validation- PQ
  • VII- Requalification
  • VIII- Impact of the medical device’s modification on sterilization process and extension of range
  • IX- EO residual
  • X- Bioburden and sterility testing

Prerequisites

Participants should have basic knowledge of microbiology and packaging requirements.

How will I learn?

MDSSPRO use interactive learning techniques, keep the course varied and account for applications and study cases. Our tutors are some of the best in the area and will make sure your learning needs are met. Choose between online or in-company courses, either can be tailored to your business needs.

Price

This online training course is available at £450 per person. We also offer this training at a special price for students, for more details contact us at admin@mdsspro.com. 

Our on-site training package can be tailored to your needs. For more details contact admin@mdsspro.com.
If you have any queries about our Sterilization by EO course, please email
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