EO Sterilization Validation Per ISO 11135
  • CODE : JOLI-0005
  • Duration : 90 Minutes
  • Level : Intermediate
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John E. Lincoln is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 35 years of experience in U.S. FDA-regulated industries, 21 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, CAPA systems, and analysis. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer-reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis/management, FDA/GMP audits, validation, root cause analysis, and others. He periodically writes for the Journal of Validation Technology. John is a graduate of UCLA.

The purpose of sterilization is to inactivate the microbiological contaminants on a manufactured medical device and thereby transform the non-sterile medical devices into sterile ones. EO (EtO, ETO, ethylene oxide) sterilization uses a highly reactive gas (100% or with N2) to accomplish this, and the method of proving this is defined by ISO 11135, the international  EO validation standard. The webinar will address product definition, microbiological issues, process definition, biological indicators (BIs), Process Challenge Devices (PCDs). The structure of the Verification and Validation Test Report will also be considered, including the opening Narrative, the Installation Qualification (IQ), Microbiological Performance Qualification (MPQ), and Physical Performance Qualification (PPQ) structure and test cases, fractional cycles, half-cycle, and production/full cycles. Equipment V&V, Software V&V (focused on the FDA’s software V&V documentation “model”), Product sterility V& V, and supporting information/documentation are part of the overall sterilization V&V effort. SAL will be discussed, as well as residuals. The conservative Overkill approach (Annex B) will be featured. A brief discussion of the AAMI TIR 28, “Product adoption and process equivalency for ethylene oxide sterilization”, as a possible alternative in some cases, and considerations of effects on existing 510(k)s or PMAs will also be considered.

Areas Covered

  • ISO 11135 overview
  • “Working” Definitions and Roles of Verification and Validation
  • Requirements; IQ; OQ; MPQ; PPQ
  • BIs, PCDs, SAL, Residuals
  • A Field-tested FDA 11 Element Documentation "Model" for the equipment software V&V documentation
  • A Typical V&V Protocol/Test Report; with different Test Cases
  • Expected Regulatory Deliverables
  • US FDA and EU MDR Concerns
  • Annual Requirements; Reviews and Revalidations
  • Pre- and post sterilization concerns
  • Documentation

Course Level - Intermediate

Who Should Attend

This webinar will provide valuable assistance to all regulated companies in evaluating their existing, upgraded/modified, or anticipated EO sterilization systems and sterile product issues. It will help attendees understand and recognize the most common software V&V failings and their fixes. The webinar will allow attendees to develop and use a repeatable EO V&V template for all associated hardware and software. This information applies to personnel/companies in the Medical Device and combination products. The employees who will benefit include:

  • Sterility Engineers
  • Microbiologists
  • Software Engineers
  • Computer Programmers and Testers
  • Sterile Load Configuration and Packaging Engineers
  • QA/QC/RA
  • Marketing
  • Management and Supervisory Personnel
  • Operations
  • R&D

Why Should You Attend

Medical devices are sterilized in a variety of ways including using moist heat (steam), dry heat, radiation, ethylene oxide gas, vaporized hydrogen peroxide, and other sterilization methods (for example, chlorine dioxide gas, vaporized peracetic acid, and nitrogen dioxide). However, Ethylene oxide sterilization is an important sterilization method that manufacturers widely use to keep medical devices safe – approximately 50% of all medical devices manufactured in the US. For many medical devices, sterilization with ethylene oxide may be the only method that effectively sterilizes and does not damage the device during the sterilization process. Medical devices made from certain polymers (plastic or resin), metals, or glass, or that have multiple layers of packaging or hard-to-reach places (for example, catheters) are likely to be sterilized with ethylene oxide. Validation is performed in accordance with ISO 11135:2014, “Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices”. Although performed since 1940, changes have been dramatic, especially in software- or firmware-controlled sterilization chambers, and the expectation of regulatory authorities such as the US FDA and the EU MDD/MDR. EO sterilization V&V includes many unique requirements over standard equipment validation, including microbiological, product sterility, biological indicators, EO residuals, and others. It is a specialized field of V&V. Adding to the problems are the facts that EO is a carcinogen and a highly flammable/explosive hazard.

Topic Background

EO/EtO Ethylene Oxide sterilization of medical devices must be validated/revalidated periodically in accordance with ISO 11135.

  • $179.00



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