Title:  EO Sterilization – Past, Present and Future

EO sterilization has been and still is the prevalent industrial method of sterilization for medical devices since the early 1960’s. This discussion will include the background and current status of EO sterilization and other methods of sterilization.

There have been some recent challenges for use of EO as a sterilant by the FDA and the EPA.  Also included in this discussion will be the alternative methods of sterilization and the challenge in bringing those alternative sterilization methods for large-scale industrial use.  Time will be allowed for questions and answers during and after the presentation.

Speaker Info and Bio:

Denny Christensen

Dennis (Denny) Christensen is a world-recognized Sterilization Expert with over 50 years of experience supporting the medical device and pharmaceutical industries. He has worked in various management roles for both medical device and pharmaceutical companies and has been responsible for the design, construction, and day-to-day operation of sterilization and laboratory facilities in the United States and Asia. He is a Voting Member on AAMI/ISO 1135 and other sterilization committees and has multiple patents for Process Challenge Devices. Denny graduated with a degree in Microbiology from South Dakota State University.

 

Title:  Recent Updates to ASTM F1980-21 (Accelerated Aging of Sterile Barrier Systems), What’s Changed?

 Accelerated aging of sterile barrier systems is a critical step in the validation of your medical device packaging.  In December 2021, ASTM F1980-21 was updated and requires manufacturers to examine the impact of moisture on their products and packaging materials and to consider that when determining the Accelerated Aging temperature and humidity parameters for your validation.   We will discuss the changes to the standard, best practices for justification letters and things to consider when selecting packaging materials.  Time will be allowed for questions and answers during and after the presentation.

Speaker Info and Bio:

Sam Sohal

Sam began working for Infinity in December 2020 after the acquisition of his company Test-O-Pac Industries and has over 30 years’ experience working with medical and pharmaceutical packaging.  He has extensive knowledge related ISO, ASTM, ISTA, and Military Packaging Standards. Sam graduated with a BS degree from San Jose State University in Packaging Engineering.

Event Information

Event Topic:
Double Feature– 1. EO Sterilization – Past, Present and Future and 2. Recent Updates to ASTM F1980-21 (Accelerated Aging of Sterile Barrier Systems), What’s Changed?

Event Description:

Date/Time:
Date(s) - 03/01/22
8:15 am - 10:30 am

Event Location:
Zoom talk: https://us02web.zoom.us/j/88274227563:

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Event Details

Cost:
$0

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