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    Features

    Revisiting the End: A Packaging and Sterilization Update

    Changing regulations and new demands from medical device manufacturers are causing packaging and sterilization suppliers to revise and update their offerings.

    Revisiting the End: A Packaging and Sterilization Update
    Revisiting the End: A Packaging and Sterilization Update
    Box out operation and production floor space at Millstone Medical headquarters in Fall River, Mass. Image courtesy of Millstone Medical Outsourcing.
    Revisiting the End: A Packaging and Sterilization Update
    Pre-validated, nested double barrier packaging with custom urethane insert. Image courtesy of J-Pac Medical.
    Revisiting the End: A Packaging and Sterilization Update
    Class 10,000/ISO 7-rated cleanroom operating space with state-of-the-art equipment and services for medical device assembly and packaging. Image courtesy of Millstone Medical Outsourcing.
    Revisiting the End: A Packaging and Sterilization Update
    Medical device assembly and packaging operations taking place in a Class 10,000/ISO 7-rated cleanroom space. Image courtesy of Millstone Medical Outsourcing.
    Revisiting the End: A Packaging and Sterilization Update
    Ultrasonic cleaning and passivation of medical devices with USP 39 high purity DI water system. Image courtesy of Millstone Medical Outsourcing.
    Revisiting the End: A Packaging and Sterilization Update
    Medical device tray seal operation taking place in a Class 10,000/ISO 7-rated cleanroom space. Image courtesy of Millstone Medical Outsourcing.
    Mark Crawford, Contributing Writer06.13.19
    Packaging and sterilization services continue to be expanding fields within the medical device industry. Although some companies still rely on traditional sterilization methods and legacy packaging materials such as Tyvek and nylon, these are becoming less common for increasingly complex devices, sensitive materials, or combination products. It is also harder for traditional methods and materials to meet tougher regulatory standards. Whenever possible, medical device manufacturers (MDMs) still prefer straightforward materials and processes that are already validated and avoid modifications to standard approaches. For example, when a major material or pouch manufacturer changes materials, OEMs must work to validate the new materials.

    “However, this can also be an opportunity for OEMs to look at other materials and processes they perhaps could not afford to develop in the past,” said Kathleen Feyti, technical sales manager for Packworld USA, a Nazareth, Pa.-based provider of sealing equipment for the healthcare industry. “Many customers are also looking for materials that can be recycled.”

    The “big three

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