AI Article Synopsis
- ISO 11137-2006 outlines a method (VDmax 15) to validate a radiation sterilization dose (15 kGy) for health care products with low sample needs, applicable to items with a bioburden of ≤ 1.5.
- The research focused on confirming this sterilization dose specifically for frozen bone allografts from the Queensland Bone Bank, given their typically low bioburden.
- Results showed all bone graft samples had a bioburden of 0, leading to all sterility tests being negative except for one positive result in structural bone allografts, supporting the use of 15 kGy as the RSD.
Article Abstract
Background: ISO 11137-2006 (ISO 11137-2a 2006) provides a VDmax 15 method for substantiation of 15 kGy as radiation sterilisation dose (RSD) for health care products with a relatively low sample requirement. Moreover, the method is also valid for products in which the bioburden level is less than or equal to 1.5. In the literature, the bioburden level of processed bone allografts is extremely low. Similarly, the Queensland Bone Bank (QBB) usually recovers no viable organisms from processed bone allografts. Because bone allografts are treated as a type of health care product, the aim of this research was to substantiate 15 kGy as a RSD for frozen bone allografts at the QBB using method VDmax 15-ISO 11137-2: 2006 (ISO 11137-2e, Procedure for method VDmax 15 for multiple production batches. Sterilisation of health care products - radiation - part 2: establishing the sterilisation dose, 2006; ISO 11137-2f, Procedure for method VDmax 15 for a single production batch. Sterilisation of health care products - radiation - part 2: establishing the sterilisation dose, 2006).
Materials: 30 femoral heads, 40 milled bone allografts and 40 structural bone allografts manufactured according to QBB standard operating procedures were used.
Method: Estimated bioburdens for each bone allograft group were used to calculate the verification doses. Next, 10 samples per group were irradiated at the verification dose, sterility was tested and the number of positive tests of sterility recorded. If the number of positive samples was no more than 1, from the 10 tests carried out in each group, the verification was accepted and 15 kGy was substantiated as RSD for those bone allografts.
Results: The bioburdens in all three groups were 0, and therefore the verification doses were 0 kGy. Sterility tests of femoral heads and milled bones were all negative (no contamination), and there was one positive test of sterility in the structural bone allograft. Accordingly, the verification was accepted.
Conclusion: Using the ISO validated protocol, VDmax 15, 15 kGy was substantiated as RSD for frozen bone allografts manufactured at the QBB.
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| http://dx.doi.org/10.1007/s10561-008-9064-5 | DOI Listing |
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