Show simple item record

dc.contributor.authorNguyen, Huynhen_US
dc.contributor.authorA. F. Morgan, Daviden_US
dc.contributor.authorI. Sly, Lindsayen_US
dc.contributor.authorBenkovich, Morrisen_US
dc.contributor.authorCull, Sharonen_US
dc.contributor.authorR. Forwood, Marken_US
dc.date.accessioned2017-04-24T14:57:49Z
dc.date.available2017-04-24T14:57:49Z
dc.date.issued2008en_US
dc.date.modified2010-02-09T05:29:12Z
dc.identifier.issn13899333en_US
dc.identifier.doi10.1007/s10561-008-9064-5en_AU
dc.identifier.urihttp://hdl.handle.net/10072/28697
dc.description.abstractBackground 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.en_US
dc.description.peerreviewedYesen_US
dc.description.publicationstatusYesen_AU
dc.languageEnglishen_US
dc.language.isoen_AU
dc.publisherSpringeren_US
dc.publisher.placeNetherlandsen_US
dc.relation.ispartofstudentpublicationNen_AU
dc.relation.ispartofpagefrom139en_US
dc.relation.ispartofpageto147en_US
dc.relation.ispartofissue2en_US
dc.relation.ispartofjournalCell and Tissue Bankingen_US
dc.relation.ispartofvolume9en_US
dc.rights.retentionYen_AU
dc.subject.fieldofresearchMulti-Disciplinaryen_US
dc.subject.fieldofresearchcode999999en_US
dc.titleValidation of 15 kGy as a radiation sterilisation dose for bone allografts manufactured at the Queensland Bone Bank: application of the VDmax 15 methoden_US
dc.typeJournal articleen_US
dc.type.descriptionC1 - Peer Reviewed (HERDC)en_US
dc.type.codeC - Journal Articlesen_US
gro.date.issued2008
gro.hasfulltextNo Full Text


Files in this item

FilesSizeFormatView

There are no files associated with this item.

This item appears in the following Collection(s)

  • Journal articles
    Contains articles published by Griffith authors in scholarly journals.

Show simple item record