Developing an ethylene oxide (EO) sterilization process for a product with limitations

Instructor: Gerry O Dell
Product ID: 701680
Training Level: Intermediate to Advanced
  • Duration: 80 Min

recorded version

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Training CD

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Read Frequently Asked Questions

This EO sterilization training Webinar will discuss how to modify EO sterilization process for complicated medical products which are sensitive to moisture, temperature, vacuum changes.

Why Should You Attend:

Medical products have become more complicated with many containing computer chips, batteries, antibiotics, or other items/materials that make sterilization a significant challenge. These products that present difficult challenges to the EO sterilization process may include those products that have sensitivity to temperature, have moisture limitations, are sensitive to vacuum changes (either level or rate), retain EO, have batteries, or a combination of these factors. Developing a sterilization process presents a challenge but in virtually all cases a process can be developed that meets the requirement to have a sterile functional product.

This presentation will address the various modifications that can be made to the EO process to accomplish this goal and the impact of those modifications. We will discuss the methods to limit moisture exposure, Running a low temperature process, How to address vacuum sensitivity, How to reduce EO residuals.

Areas Covered in the Seminar:

  • How to limit moisture exposure.
  • Running a low temperature process.
  • How to address vacuum sensitivity.
  • Parameter inter-relationships.
  • How to reduce EO residuals.
  • Testing outside of the sterilization facility.
  • Considerations for validation and routine processing.

Who Will Benefit:

This webinar will provide valuable information to all companies that produce sterile products.

  • QA personnel
  • Validation specialists
  • Manufacturing personnel involved in validations
  • R&D specialists
  • Product Development Engineers

Instructor Profile:

Gerry O’Dell, is President of Gerry O’Dell Consulting, a consulting firm based in the United States with clients around the world. Gerry O’Dell consults to medical device and pharmaceutical companies related to all the major sterilization methodologies, microbiology, environmental control, laboratory compliance, failure investigation, etc. Her varied background includes extensive knowledge in sterilization technology, laboratory management, microbiological testing (including pyrogens), decontamination of returned goods, and compliance.

Prior to starting Gerry O’Dell Consulting, she worked for Johnson & Johnson Medical, Inc. as the Manager of Laboratory & Sterilization Services which managed the sterilization program for J&J Medical in addition to providing laboratory testing services to several J&J companies. Before becoming a part of Johnson & Johnson Medical, Gerry was Manager of Sterilization Services at Critikon, Inc where she started as a Lab Technician. She holds both a Bachelor and Master of Science degree in Microbiology from the University of South Florida and has over twenty-five years of experience in the medical device industry.

Gerry is a member of the Association for the Advancement of Medical Instrumentation (AAMI) and actively participates in the Sterilization Standards Committee activities. She is currently Co-Chair of the AAMI Industrial Ethylene Oxide Sterilization Working Group and a member of the U.S. Sub-TAG for ISO/TC 198/WG 1. She is also a member of the Sterilization Residuals, Radiation Sterilization, Sterility Assurance Level (SAL), Compatibility of Materials Subject to Sterilization, and Microbiological Methods Working Groups; actively participating in the development of several standards and guidance documents. Gerry is a Registered Microbiologist with the National Registry of Microbiologists in the area of Consumer Products & Quality Assurance. She is also a member of the American Society for Microbiology (ASM), American Society for Testing & Materials (ASTM), and PDA.

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