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.

As an example, in January 2018 the latest revision of ASNI / AAMI / ISO 11737-1 was published. This document outlines methods for determining the microorganism populations on healthcare products and has numerous applications. The latest revision expands on several topics that directly affect radiation sterilization dose setting for Method 1 and Method VDmax, including guidance on Limit of Detection (LOD), Bioburden Spikes and Method Suitability.

We understand these changes and are prepared to help our customers through the complex process of dose setting.

  •  First, though, it is paramount to establish a bioburden baseline. We do this by gathering data on the whole product or, if that data are not available or established previously in the development process, on the product’s components or raw materials. .

The knowledge we gain by establishing the bioburden baseline leads to information to support the radiation sterilization validation scope. Our strong understanding of a product’s bioburden means we can more accurately determine the appropriate method of dose validation, as well as the test parameters and recovery efficiency method.

Recovery efficiency demonstrates the effectiveness of the bioburden test method to recover the population of microorganisms on your product.   When utilizing recovery efficiency, a correction factor is determined and applied to provide a more accurate estimation of the product bioburden.

Depend on Our Extensive Experience

Customers with complex products requiring multiple recovery methods can rely on the extensive experience of the WuXi AppTec team members. For example, we may recommend multiple recovery methods for a complex product when device components require different test parameters (e.g., powder versus inner packaging). And we understand Limit of Detection (LOD) and how to apply LOD to meet the scope of the project as well as the dose-setting method requirements.

The effectiveness of the bioburden test method depends on several factors, including the complexity of the product and test parameters. In determining the appropriate test method (extraction, diluent, media) for the recovery of product bioburden, we work with our customers to understand the product, its clinical use and the manufacturing aspects. This information ultimately supports our development of effective test methods and study parameters.

For more information on working with us to determine your product’s bioburden baseline and dose-setting tests, contact us.

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