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Published Article

PUBLISHED ARTICLE

Proceed with Caution: Medtech Seeks Safe Packaging and Sterilization Solutions

Published In: Orthodpedic Design & Technology Magazine

Concerns surrounding ethylene oxide have brought the packaging and sterilization segments to the forefront for medical device manufacturers.


Packaging and sterilization services play a critical role in delivering a device to market and ensuring compliance with even the most stringent healthcare standards. Sterilization ensures the product is safe for patients to use; packaging protects the device and maintains the sterile barrier to the point of use. Packaging also enables medical staff to clearly identify parts and confirm no punctures or abrasion damage occurred during transport.

 

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Martell Winters

Martell Winters

BS, RM/SM (NRCM), CISS-RAD
Scientific Competency Expert

Martell Winters is a specialist microbiologist (NRCM) and a radiation specialist (AAMI). He has been at Nelson Labs for 24 years and spent his earlier years working in the Radiation Sterilization group, responsible for bioburden testing and radiation validation studies. His specialties include microbiological process validation and radiation sterilization of medical devices, allograft tissue, and pharmaceutical products.

Wendy Mach

Wendy Mach

RM (NRCM), CQA (ASQ)
Packaging Expert

Wendy Mach has over 24 years of medical device manufacturing and laboratory experience. She worked in the medical manufacturing environment in Minnesota for seven years, performing ethylene oxide (EO) and gamma radiation sterilization validations. While at the manufacturing site, she also insourced the microbiology tests for sterility assurance and related equipment validation. Wendy also spent...

Jennifer Gygi

Technical Consulting Manager for Nelson Laboratories

Dania G. Cortes

Senior Manager of Science for Nelson Laboratories