Use the scheduling tool below to browse all the available sessions, speakers and topics at this year's event. Find the content and sessions to fit all of your educational needs and ensure you get the most out of your time at the show.

Nelson Laboratories Workshop: Radiation Sterilization: Selection of a Validation Approach & Updates in the Radiation Industry

Speakers:

Niki Fidopiastis (Director, SteriPro Consulting)

Wendy Wangsgard, PhD (Senior Scientist, Nelson Laboratories, LLC)

Location: 210C

Date: Wednesday, February 7

Time: 1:30pm - 2:30pm

Pass Type: Expo (Free), Conference (Paid) - Get your pass now!

Free Content & Activities: Medical Device Validation – Biocompatibility Testing, Cleaning, Sterilization and Packaging

Conference Track: MD&M: Technical Solutions

Vault Recording: TBD

  • Selection of validation approach – case studies based on product requirements
  • Review of radiation validation methods
  • Updates in the industry:
    • VDmax with alternate SALs and for any sterilization dose, AAMI TIR 76
    • Having knowledgeable microbiologists involved
    • TIR 35 and product family adoption
    • New revision of 11737-1: No suggestion for >50% recovery efficiency
    • New ISO document 19930 on Assurance of Sterility
    • Understand your product bioburden (including “less-than” value calculations)
    • Endotoxin and implants
    • New AAMI and ISO working group WG 16 on vaporous hydrogen peroxide
    • AAMI CISS certification exams for sterilization specialists

Free to attend- register now to reserve your seat. Please click here to register.
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