EO Sterilization Validation and Revalidation Under ISO 11135: Practical Implementation and Lifecycle Considerations

Before beginning production-level  EO sterilization, a product labeled sterile needs to be validated to ensure the FDA-required Sterility Assurance Level (SAL)is met. The globally harmonized standard for completing such a validation is ISO 11135:2014 - Sterilization of Health Care Products - EO Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical Devices. EO is extensively used in the sterilization of medical devices. Its advantages are many:  Materials sterilized with EO are not exposed to excessive heat, moisture, or radiation. Therefore, a wide variation of materials, particularly plastic components commonly used in medical devices, can be sterilized with EO. Products can be sterilized in their final packaging (Breathable), since EO will permeate the sealed films and cartons used to package the device .Ethylene oxide sterilization validation is required by regulatory agencies worldwide.  Such V&V is supported by the internationally recognized consensus standard, ISO 11135. This international standard outlines the requirement for the validation of an EO process to ensure that product processed through the validated process meets the required SAL.

_{WHY YOU SHOULD ATTEND:}

This webinar will discuss the ISO requirements for validating and periodically revalidating 1) the EO Sterilization Equipment and System, including  computerized controls and its software, and 2) the product / load itself. Ethylene oxide sterilization uses a three-part gas process that includes pre-conditioning, sterilization, and aeration. Ethylene oxide sterilization consists of four primary variables: Gas concentration; and Humidity' Temperature.  EO is an alkylating agent that disrupts cellular metabolism and reproductive processes of microorganisms. EO penetrates breathable packaging, contacting with all accessible surfaces of the product to deliver the required sterility assurance level (SAL) to meet US FDA requirements, as well as regulated residuals. Support systems, de-gassing, routing and storage of product to prevent mix-ups will also be discussed.

_{AREAS COVERED:}

• Basic steps in sterilization of medical products
• ISO 11135
• Validation of the Sterilzation Equipment
• Retort / Controls
• IQ, OQ
• MPQ 
• PPQ
• Control Software V&V 
• Overkill Approach
• Sterile Load V&V
• BI's and PCD's

_{WHO SHOULD ATTEND:}

• Quality Assurance Departments
• Regulatory Affairs Departments
• Research and Development Departments
• Engineering Departments
• Production Departments
• Operations Departments
• Senior Management

Course Director: JOHN E. LINCOLN

John E. Lincoln has over 40 years experience in U.S. FDA-regulated industries, 30 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan.  He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files.  He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D).  In addition, John has prior experience in military, government, electronics, and aerospace.  He is a peer reviewed, author, teacher and speaker.   John is a graduate of UCLA.