Validation of sterilization by ethylene oxide according to EN ISO 11135

Course Description

This course is designed to provide participants with understanding of the EN ISO 11135 requirements for sterile medical devices and compliance with EU MDR and UK MDR.

This 1 day training provides an in depth knowledge of the EN ISO 1135 requirements and study cases.

Learning objectives / course outcomes

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

Identify the links between UK MDR/ EU 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- Microbiology: Bioburden and sterility testing

III- Design of the device’s material and interaction with ethylene oxide

IV- What type of indicator to use

V- Validation- IQ, OQ, PQ

VI- Biocompatibility: EO residual

VII- Requalification

VIII- Release of sterile products in routine

IX- Impact of the medical device’s modification on sterilization process and extension of range

Prerequisites

Participants should have basic knowledge of microbiology and packaging requirements.

How will I learn?

MDSSPRO uses interactive teaching techniques, keeping the course varied and stimulating through exercises, working applications and case studies. Experienced and knowledgeable industry-leading tutors ensure individuals stay engaged throughout the course and that the learning objectives are met.

The course can be run online or onsite at company offices.

MDSSPRO’s online training course is powered through a Performant Software platform. Online tutors are available throughout the length of the course offering full support to course participants, answering questions, offering advice and explaining course material as required.

Price

We are providing online training course for £500 per person on our platform https://mdsspro.talentlms.com/index. The content is available for 3 months after registration.

A certificate is delivered after completion of the training.

On site training is tailored by on your needs. For more details contact office.mdsspro@gmail.com