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    Dig deeper into topics and the science behind our services, as well as ways we can help solve your business challenges.

    How to Evaluate a New Product Against an Existing Product in a Validated Ethylene Oxide Process

    By: Julie Barker

    As defined in Section 12 of ISO 11135:2014, a new or modified (“candidate”) product can be added to a validated Ethylene Oxide (EO) sterilization process

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    3 Methods to Establish the Sterilization Dose of a Medical Device

    By: Dr. Bart Croonenbroghs

    In the medical device industry there are 3 methods to establish the sterilization dose of a medical device …

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    Sterilization Dose Audits – The “Why” and the “How”

    By: Zabrina Tumaitis-Namba

    In the medical device industry, sterilization processing is performed to obtain a Sterility Assurance Level (SAL) as required by regulatory authorities to designate the treated product as “sterile”. When SAL...

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    Establishing Maximum Acceptable Dose for Medical Devices in Radiation Sterilization

    By: Mike Flanagan

    Medical device manufacturers using ionizing radiation (gamma, electron beam or X-Ray) for sterilization purposes should establish the maximum acceptable dose...

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    Gamma: The heart of radiation sterilization past, present and future

    By: Nordion Staff

    The Covid-19 global pandemic of 2020 has brought into sharp focus the critical role that the medical device supply chain plays in the terms of bringing safe, effective healthcare to...

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