Basics of Ethylene Oxide Sterilization Process Requirements

Charity Ogunsanya

Course description

For products that claim a desired Sterility Assurance Level (SAL), proof of a defined SAL (specification) is achieved through the product’s sterilization and sterility assurance controls. Compliance Observations cited each year by the FDA on Form 483s that relates to Sterilization and Sterility Assurance processes shows that there are deficiencies associated with these key processes that are critical to a product’s sterility including inappropriately qualified and trained personnel required as key staff to implement a fully compliant sterilization process.

This can potentially lead to Product Failures (Sterility Failures), product Non-conformances, Product Recalls, FDA’s Warning Letters, Consent Decrees and discontinuance of commercial operations which may negatively impacts a company’s profitability. FDA regulated industries that produce products with a defined SAL are obligated to have adequately trained and knowledgeable staff or Subject Matter Experts (SMEs) within sterilization and sterility assurance to provide applicable regulatory guidance with the impacted systems.

This accredited training introduces both new and existing employees to the requirements of ISO 11135 and other applicable regulations. The role of Ethylene Oxide (EtO) sterilization used for certain manufactured products, supplies and ancillary systems cannot be overemphasized. Having a clear understanding of the detailed requirements of EtO sterilization process and its impact on a product’s material of composition is critical to determining the suitability of the application process.

This webinar discusses the regulations, process steps, validation requirements, routine processing and compliance requirements applicable to EtO sterilization process used for the sterilization of Medical Device and other products. The webinar will address auditors review and verification requirements and FDA’s Compliance Observations and Case Study review applicable to EtO requirements.

Upon completion of this course, you will be able to:

• Apply the regulations and steps associated with routine EtO sterilization process
• Define the basic process steps associated with routine EtO sterilization
• Describe the Installation, Operational and Performance Qualification (IOQ/PQ) Validation requirements for EtO sterilization process
• Define the process for maintaining process effectiveness and manufacturing controls for products requiring EtO sterilization
• Verify the compliance requirements of EtO sterilization process using a defined audit review verification process.
• Discuss EtO Sterilization FDA compliance citations and review requirements for compliance.

This training is part of the 10-course series required for the Cobblestone Sterilization Professional Certification Program. Attend this as a step in the certification process or as a stand-alone course for personal career advancement and training.