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    Features

    Examining Device Packaging and Sterilization Options

    Concerns over EO have device makers exploring alternative sterilization methods coupled with design changes to packaging.

    Examining Device Packaging and Sterilization Options
    An operator loads a small chamber sterilizer. Image courtesy of Boulder IQ.
    Examining Device Packaging and Sterilization Options
    3M hospital sterilizers. Image courtesy of Boulder IQ.
    Examining Device Packaging and Sterilization Options
    Reusable sterilization filter made from Porex Virtek PTFE. Image courtesy of Porex.
    Examining Device Packaging and Sterilization Options
    Mechanical impact testing a large crate using the Horizontal Impact Test System (HITS). Image courtesy of WESTPAK Inc.
    Examining Device Packaging and Sterilization Options
    Gross leak detection (bubble) testing per ASTM F2096 using Shark Tank tester. Image courtesy of WESTPAK Inc.
    Examining Device Packaging and Sterilization Options
    Random vibration testing a large crated product per ASTM D4728 using MONGO hydraulic vibration tester. Image courtesy of WESTPAK Inc.
    Mark Crawford, Contributing Writer06.02.21
    Packaging and sterilization are dynamic markets these days in the medical device industry, thanks to the new EU Medical Device Regulation (MDR), the COVID-19 pandemic, wobbly supply chains, tougher regulations, and changing healthcare demands. Although there is still an abundance of change to contend with, medical device manufacturers (MDMs) are settling (cautiously) into a “new normal” for packaging and sterilization. However, “there is still some pressure on supply chains with raw material shortages, especially with recent market tightening for sourcing and lead times,” said Tom Williams, general manager for Millstone Medical Outsourcing, a Fall River, Mass.-based provider of packaging and distribution solutions for the medical device industry.

    With the EU MDR newly launched, MDMs that are still behind are hustling to convert from non-sterile to sterile packaging. With MDR’s sharper focus on risk and safety, grandfathered devices with a CE mark will require recertification.

    Continue reading this story and get 24/7 access to Medical Product Outsourcing for FREE


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