Sterilization by EO course
Sterilisation by Ethylene Oxide (EO) Course
Validation of Sterilisation using Ethylene Oxide (EO) in line with EN ISO 11135
This one-day intensive training course provides an introduction and understanding of EN ISO 11135, the international standard for validation of sterilisation processes using Ethylene Oxide (EO), to sterilise medical devices.
The course addresses the connection between MDR and ISO 11135 requirements and provides the regulatory and technical knowledge on validating sterilisation processes and maintaining sterile manufacturing processes to the highest standard globally
Using case studies, practical examples and guided exercises, delegates will have the foundation to implement compliant sterilisation processes, manage sterilisation validation reports, and maintain product safety and performance within the range of specifications.
- Identify the link between MDR / UK MDR 2002 and EN ISO 11135
- Understand EO sterilisation validation requirements
- Define each type of biological and chemical indicators in line with ISO 11138
- Set the requirements for routine sterilisation and batch release
- Identify key parts of a sterilisation validation report or respond to the report.
Learning objectives/outcomes:
At the end of the course, participants will be able to:
Intended Audience:
This course is intended for professionals with responsibilities for quality, compliance, or product development in the medical device sector, including:
Regulatory Quality Assurance Managers
Design and Development Engineers
Quality control specialists
Course Content:
- I. Introduction
- II. Device Materials Characterisation and EO Interaction
- III. Indicators Selection and Confirmation
- IV. Validation - Installation Qualification (IQ)
- V. Validation - Operational Qualification (OQ)
- VI. Validation - Performance Qualification (PQ)
- VII. Requalification Criteria
- VIII. Impact of Device Changes on Process Validation
- IX. EO Residuals and Analysis
- X. Bioburden and Sterility Analysis
What You Should Bring?
Attendee knowledge levels are expected to have a fundamental understanding of:
- Microbiology and sterility principles
- Packaged medical device-specific requirements for validation
Learning Approach
The training will include discussions, hands-on exercises and examples to promote an engaging and collective learning event. The presenters are very experienced validation professionals in sterilisation validation to ensure each attendee has a practical understanding and insight into applying the standard.
The training is available in-person and virtually to accommodate companies with operational flexibility.
Cost
Virtual training pricing: £450 per attendee
(Discounts for students are available - please contact us)
- On-site training - In-person training can be delivered as per your requirements. Please contact admin@mdsspro.com for pricing and scheduling
Why Take This Course
This course is a solid introduction to EN ISO 11135 for designing, validating and monitoring EO sterilisation processes. The training is conducted by experienced auditors and assessors, offering participants technically accurate and practically applicable information.
Rest Assured with Regulatory Confidence
With the changing landscape of the MDR/UK MDR 2002, being informed about sterilisation validation is crucial. This course provides your team with the information they need to document, manage and maintain sterilisation processes in compliance with international quality and safety of products standards.
Reach Out
Let’s Build Regulatory Compliance Confidence Together At MDSSPRO, we have your back when it comes to regulatory compliance of your medical devices. Whether you need training or auditing services, we are here to assist you in the journey towards improving device quality and safety.
Let’s Build Compliance Confidence Together
Partner with MDSSPRO to ensure your medical devices meet the highest regulatory standards. From tailored training to expert auditing, we’re here to guide you every step of the way toward full MDR compliance.
