Radiation sterilization is a general term used to describe processes that use gamma radiation, electron beams, or x-rays to sterilize medical devices, subassemblies, or raw materials. LexaMed provides validation and consulting services to customers with products that are sterilized with radiation. These services also include the full range of microbiological tests that are required to substantiate and maintain the sterilization process. Additionally, radiation sterilization requires the implementation of a program to monitor and control the bioburden present on the product from the routine manufacturing process. LexaMed can help provide device manufacturers with the tools to enact an effective bioburden program via effectively written SPOs satisfying current regulatory expectations.
LexaMed develops protocols for radiation sterilization validation that conform to the requirements of ANSI/AAMI/ISO 11137-1 and provide a laboratory-level of detail that allow a reviewer to quickly assess the procedures and acceptance criteria. The most straightforward form of validation is the VDmaxmethodology of dose substantiation described in ANSI/AAMI/ISO 11737-2. However, it is only appropriate when bioburden levels are controlled to ≤ 1500 CFU/unit. The native bioburden on the product is used to determine an appropriate reduced verification dose. Routine product exposed to the verification dose is then subjected to sterility testing; with the results used to substantiate a sterility assurance level (SAL) of 10-6 at the specified sterilization dose. Using the VDmax method keeps sample sizes to a minimum, and helps to reduce the overall cost of validation.
Radiation sterilization requires periodic dose audits and bioburden estimations in order to maintain the process. LexaMed can further assist device manufacturers with establishment, implementation, and maintenance of a quarterly dose audit program. Our consulting experts can provide the following:
Our ISO 13485 certified laboratory provides routine bioburden estimation services, and will coordinate sample shipment to and from the contract irradiator for verification dose exposures. Typically, these activities are performed on a quarterly basis, and LexaMed strives to satisfy customer expectations for quality and turnaround time for these scheduled events.
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