An Introduction To Ethylene Oxide (EO) Sterilization For Medical Devices Training Course (Online Event)

(MENAFN- GlobeNewsWire - Nasdaq) Dublin, April 14, 2025 (GLOBE NEWSWIRE) -- The "An Introduction to Ethylene Oxide (EO) Sterilization for Medical Devices Training Course" conference has been added to ResearchAndMarkets.com's offering.

This course provides an introduction to these regulatory requirements as they relate to EO sterilization and how manufacturers may demonstrate compliance.

Sterile devices are free of viable microorganisms and EO sterilization is one of the key processes in the production of sterile medical devices.

Regulations for medical devices include particular requirements for devices supplied or intended to be used in a sterile state. These regulatory requirements relate to general safety and performance aspects for the products, and the requirements for independent, third-party conformity assessment of the processes for achieving sterility. Evidence of successful sterilization by Ethylene Oxide is important and expected when demonstrating conformity with the regulations.

These requirements have been supported by a portfolio of standards on:

• Designating products as sterile;
• Validating and routinely controlling the sterilization process;
• Determining whether the sterilization process has any adverse effect on the devices; and
• Maintaining sterility over time with appropriate sterile barrier systems

Benefits in Attending

• Gain an overview of medical device sterilization by EO
• Understand the principles of EO validation for medical devices
• Learn the regulatory requirements for EO sterilization and how to comply
• Gain an awareness of supporting standards and their interrelationships

Please note that delegates will require access to a copy of ISO 11135 to gain the most from this training.

Certifications:

• CPD: 3 hours for your records
• Certificate of completion

Who Should Attend:

• Microbiologists and sterilization professionals
• Quality Management System (QMS) specialists
• Regulatory Compliance specialists
• Internal Auditors
• Regulatory and Quality professionals

Key Topics Covered:

Ethylene Oxide Sterilisation Principles

• Background and the ISO 11135 standard
• Microbiocidal principles of ETO
• ETO sterilisation process stages and critical parameters
• Product characteristics affecting/affected by ETO

Validation of Ethylene Oxide Sterilisation Installation and Operational Qualification (IQ & OQ)

• Microbiological performance qualification (MPQ)
• Use of biological and chemical indicators
• Physical performance qualification (PPQ)
• Product adoption into existing validations - ISO 11135 and AAMI TIR 28

Routine Monitoring and Control

• Product release from sterilisation
• Assessment of change and revalidation
• Bioburden monitoring and ISO 11737-1

Ethylene Oxide Residual Control and Testing

• Establishing limits - ISO 10993-7
• Testing process and considerations
• Product release considerations

Speakers:
Annette Callaghan
Sterile Management Systems
A quality management professional, chartered biologist and member of the Royal Society of Biology, with over 35 years' experience in the medical device, pharmaceutical, biotechnology and food industries. Extensive knowledge of quality and environmental management systems, internal and third-party auditing and personnel training. Eligible to act as a Qualified Person as defined in Directive 2001/83/EC, as amended (previously 75/319 et al.) since 1993. A Qualified Notified Body Lead Auditor since 2002 (IRCA ref: 1182641).
For more information about this conference visit

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