Radiation Sterilization: Verifying Dose Survivors

A wealth of knowledge was gained from a historic data review of radiation dose verification failures. Our experts highlight the importance and application of this data set as well as its benefit to device manufacturers. 

In last week’s blog post, we highlighted the importance of bioburden monitoring, both quantitatively and qualitatively, as supportive evidence for a valid radiation dose. We arrived at this conclusion through a historic data review of verification dose experiments.

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Topics: Medical Device, Technical Expertise, ISO 11737-1, Radiation Sterilization Validation

Radiation Sterilization: Product Bioburden and Verification Dose

WuXi AppTec supports the best practice of monitoring bioburden quantitatively and qualitatively to ensure the established radiation dose is valid.

For many medical device manufacturers, radiation sterilization is a critical element of sterility assurance programs. ISO 11137-1, ISO 11137-2 and ISO TS 13004 specify the requirements for establishing a sterilization dose based on known product bioburden, including quantity and resistance.

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Topics: Medical Device, Technical Expertise, ISO 11737-1, Radiation Sterilization Validation

Helping Manufacturers Understand Product Bioburden Before Dose Setting

Posted by Jill Warren, Technical Specialist on July 16, 2018

To determine the best-suited dose-setting method, we first help manufacturers better understand product bioburden by employing the most effective testing methods and techniques.

We are equipped to support a broad range of products—from simple to complex, including complicated situations.

An advantage of partnering with WuXi AppTec is that we stay up-to-date on industry changes, and work with you to find the process that best fits your product needs.

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Topics: Medical Device, Regulatory, Technical Expertise, Microbiology, ISO 11737-1, Bioburden, Radiation Sterilization Validation