Sterilization Process for Product Developers - A Complete Guide

Gerry O'Dell
Instructor Gerry O'Dell
Product Id 600600
Duration 90 Minutes
Version Recorded
Original Price $295
Special Offer Price $10
Refund Policy
Access recorded version only for one participant; unlimited viewing for 6 months

Sterilization Process for Product Developers - A Complete Guide

Overview:
Product developers have the responsibility of the development of medical devices or healthcare products that will be sterilized; however they may not have an adequate understanding of the sterilization processes 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 and Product Developers 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 sterilization. It will also provide guidance on how the sterilization process can be changed to address specific product needs such as temperature or moisture sensitivity.

Why you should attend: The cost of proceeding down the wrong path for sterilization can be extremely costly not only financially but in the time delay of bringing a new product to market. This webinar will help product development personnel have a better understanding of how to determine what sterilization method should be used for the new product under development. What the important considerations are that need to be evaluated from materials, product and packaging standpoint as well as other factors that must be considered will be addressed.

Areas Covered in the Session:
  • Review of the various sterilization methods
  • Basics of EO sterilization
  • Basics of radiation sterilization
  • Basics of moist heat sterilization
  • Other forms of sterilization
  • Introduction into product considerations
  • Material related issues
Who Will Benefit:
  • Personnel with the responsibility for product design and development
  • R&D Engineers
  • Product Managers
  • Packaging Engineers
  • Quality Engineers
Speaker 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, and compliance. Prior to starting Gerry O’Dell Consulting, she worked for Johnson & Johnson and has over twenty-five years of experience in the medical device industry. Gerry is a Registered Microbiologist with the National Registry of Microbiologists in the area of Consumer Products & Quality Assurance. Gerry is actively involved in the development of sterilization standards and is currently Co-Chair of the AAMI Industrial Ethylene Oxide Sterilization Working Group. She is also a member of several other working groups which are related to EO residuals, Radiation Sterilization, Sterility Assurance Levels, Reusable Devices, and Microbiological Methods.

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