Fundamentals of Sterilisation Validation for Single Use Medical Devices

Ethylene Oxide sterilisation is commonly used to terminally sterilise single use medical devices. The increasing regulatory and compliance requirements in the management of sterilisation processes places additional demands on project teams including those involved in the design and development of new innovative products as well as those involved in operational and supply chain improvements and efficiencies. This 1 day course details the compliance requirements and the current industry best practice approaches to validation and product testing using practical examples. It is designed to provide a comprehensive knowledge of an EO sterilisation validation process, which delivers the required Sterility Assurance Level, Microbiological Performance Qualification and Physical Performance Qualification to ensure repeatability of the routine processing. The course also addresses and explains associated product testing and test method validation for bioburden, product endotoxin, test of sterility, bacteriostasis & fungistasis and residuals. The course explains the impact of design and manufacturing changes on the sterilisation process, associated product testing and gives examples of how these may be assessed and managed through the validation and change control processes. Sterilisation processes are audited regularly by Regulatory Bodies and this course will give a background for preparing for a regulatory inspection. Routine management of the sterilisation process from pre-sterile checks to defining a product release process will be addressed. This course is available exclusively on an In-House basis

Delivery Mode

  • Customised

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What's covered?

  • Explanation of the EO sterilisation processes.
  • Microbiological and Physical Performance aspects of sterilisation validations.
  • Responsibilities of all the stake holders; design team, manufacturers, laboratories and sterilisation sub-contractors.
  • Product testing and test method validation.
  • Assessment of process and product changes
  • Regulatory requirements and how to prepare for a regulatory audit.
  • Process validation – different approaches that may be used.
  • Management of routine sterilisation cycles, product release and process deviations.

Who should participate?

Sterilisation validation requires Microbiology, R&D, Engineering, Packaging, Quality, Operations and Regulatory inputs to ensure the validated process is suitable for routine use, changing supply chain requirements while meeting compliance requirements. As most companies use contract sterilisation contractors, this course helps customers to engage with their sterilisation sub-contractors to develop compliant while cost effective validation strategies.

• R&D engineers
• Operations
• Regulatory
• Microbiologists
• Quality
• Technical

What will I learn?

Participants achieve the following learning outcomes from the programme;
• Identify industry best practices and regulatory compliance requirements and demonstrate these sterilisation projects.
• Plan the requirements of an EO sterilisation validation and related product testing, including EO Requalification activities.
• Develop and communicate validation strategies with internal teams and sterilisation sub-contractors.
• Analyse and Interpret validation results.
• Assess the effects of product and packaging design & manufacturing changes on an existing sterilisation process and product testing.
• Evaluate validation documentation for a regulatory inspection and continued quality compliance.
• Generate requirements to support Product Release Activities

Who are the tutors?

Maura Walsh

Maura completed a graduate degree in DCU, a PhD in Bristol University and a Post-Doctorate in Trinity College, prior to gaining her industrial experience. In her career, she has worked primarily within the areas of Quality Systems and Sterilisation/Microbiology and this also included being an auditor with NSAI within the Medical Devices sector. Maura has worked in a significant number of multinationals in Europe, US and Asia as well as indigenous Irish start-ups supporting both sterilisation and microbiology projects to provide leadership and direction to ensure their project is delivered in a timely and compliant manner within Quality Systems and Microbiology/Sterilisation.

Having worked in the areas of microbiology and sterilisation for more than 20 years, Maura has many years practical experience in sterilisation projects and uses these examples throughout the training to keep the audience engaged and actively participating in the session. She has experience in Ethylene Oxide, Gamma, E-Beam and steam sterilisation types and a unique ability to explain the terminology in a way that is easy for other disciplines to understand so that they do not feel intimidated by the topic.

Maura understands that many design, regulatory, quality and supply chain personnel need to interact with sterilisation suppliers and test laboratories during the lifecycle of their product and that these relationships are more productive when the team has an understanding and appreciation of sterilisation validation requirements.

Maura Walsh


Maura Walsh


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