ComplianceOnline

Ethylene Oxide (EO) Sterilization Basics for R&D Engineers

Instructor: Gerry O Dell
Product ID: 701272
  • Duration: 90 Min

recorded version

$299.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

$500.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This Sterilization training will provide valuable information to companies that design products for terminal sterilization with ethylene oxide.

R&D Engineers have the responsibility of the development of medical devices or healthcare products that will be sterilized by ethylene oxide (EO), however they may not have an adequate understanding of the sterilization process and its impact to the functionality of the product and its package. This presentation will provide information that can be used by R&D Engineers to aid them in the selection of materials, design characteristics and appropriate packaging by providing them with a basic knowledge of what is involved in the process of EO sterilization. It will also provide guidance on how the EO sterilization process can be changed to address specific product needs such as temperature or moisture sensitivity.

Areas Covered in the seminar:

  • Review of the properties of ethylene oxide.
  • Lethality of ethylene oxide.
  • Basics of EO sterilization.
  • Interrelationship of the parameters of EO sterilization.
  • Introduction into product considerations.
  • Material related issues.
  • Basic aspects of EO residuals.
  • What aspects of product design impact EO sterilization.
  • What aspects of EO sterilization impact the product.
  • How changes to the materials, product, package, and manufacturing process impact EO sterilization.
  • What testing may be required for changes.

Who will benefit:

This webinar will provide valuable information to companies that design products for terminal sterilization with ethylene oxide.

  • Personnel with the responsibility for product design and development
  • R&D Engineers
  • Product Managers
  • Packaging Engineers
  • Quality 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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