Originally Aired - Wednesday, October 16 • 9:00 AM - 9:30 AM Central Time (US & Canada)
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Location: Room 103 B
Title: How Changing Sterilization Methods Impact Medical Device Packaging Validations
Session Handouts Available at Speaker Approval: 1
Description:
The landscape of medical device sterilization is changing. Ethylene oxide is seeing more regulatory scrutiny and other gaseous technologies are looking to fill the gaps. X-ray looks to significantly grow capacity where gamma is unable keep up with demand. A change in sterilization method may be necessary to accommodate your medical device's future growth. You have carefully designed your packaging to allow your device to be sterilized and to protect your product throughout the distribution and shelf life of the product. Will your packaging be able to withstand these changes? How are the regulatory and quality requirements for packaging validation impacted by a change in sterilization method? In this session, we will discuss what to consider regarding packaging and packaging validation when making a change to sterilization methods.
Type: Technical Session
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