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    Whitepapers

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

    Pros, Cons and Considerations of Using
    a Developmental Chamber During
    Ethylene Oxide Validation

    By: Nicole Palluck

    A developmental chamber is usually smaller than a production chamber and used to perform studies to support Ethylene Oxide validation. This white paper discusses use of a developmental chamber for...

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    Material Consideration Radiation Processing

    By: Sterigenics Staff

    Each polymer reacts differently to ionizing radiation. Thus, it is important to verify that the maximum administered dose will not have a detrimental effect on the product’s function or the...

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    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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    EO Residue Levels in Medical Devices: Best Practices for Demonstrating Compliance with ISO

    By: Thor Rollins, Gregory Grams, Mike Padilla, Peter Strain and Erik Haghedooren

    Sterilizing medical devices via ethylene oxide gas is an effective and common practice within the industry. EO gas is active at a relatively low temperature compared to other methods, such...

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