Development of a bacteriophage model system to investigate virus inactivation methods used in the treatment of bone allo
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Development of a bacteriophage model system to investigate virus inactivation methods used in the treatment of bone allografts Carol Bienek Æ Lynsay MacKay Æ Gillian Scott Æ Anthony Jones Æ Richard Lomas Æ John N. Kearney Æ George Galea
Received: 11 January 2006 / Accepted: 10 May 2006 / Published online: 24 October 2006 Springer Science+Business Media B.V. 2006
Abstract Bone allografts are commonly used in a variety of surgical procedures, to reconstruct lost bone stock and to provide mechanical support during the healing process. Due to concerns regarding the possibility of disease transmission from donor to recipient, and of contamination of grafts during retrieval and processing procedures, it is common practice to sterilise bone allografts prior to issue for clinical use. It is vital that the sterilisation processes applied to allografts are validated to demonstrate that they achieve the required level of bioburden reduction, and by extension that validated models are used for these studies. Two common sterilisation protocols applied to bone allografts are gamma irradiation and ethylene oxide gas sterilisation, and there are currently no validated models available for measuring the anti-viral efficacy of ethylene oxide treatment with regard to bone allografts or readily useable models for assessing the anti-viral efficiency of gamma irradiation treatment. We
have developed and validated models for both these sterilisation processes, using the bacteriophage /·174, and utilised the models to measure the antiviral activity of the standard ethylene oxide and gamma irradiation sterilisation processes applied to bone allografts by the National Blood Service. For the irradiation model, we also utilised bacterial spores (Bacillus pumilus). Our results show that ethylene oxide sterilisation (which can only be applied to lyophilised grafts) inactivated >6.1log10 of the model virus, and gamma irradiation (at 25–40 kGy and applied to frozen allografts) inactivated 3.6–4.0log10 of the model virus and >4log10 of the bacterial spores. Gamma irradiation at this dosage is therefore not in itself a sterilisation process with respect to viruses.
C. Bienek Æ L. MacKay Æ G. Scott Æ A. Jones Æ G. Galea Protein Fractionation Centre, Scottish National Blood Transfusion Service, Ellen’s Glen Road, Edinburgh, EH17 7QT, UK
Introduction
R. Lomas (&) Æ J. N. Kearney National Blood Service Tissue Services, Liverpool Blood Centre, 14 Estuary Banks, Liverpool, L24 8RB, UK e-mail: [email protected]
Keywords Bone allograft Æ Sterilisation Æ Ethylene oxide Æ Irradiation Æ Bacteriophage
Bone allografts, derived from cadaveric or living donors, are widely used surgically, principally in orthopaedic treatments. These allografts may be made available as unprocessed ‘fresh frozen’ allografts or be extensively processed prior to implantation, in order to remove marrow components and render them suitable for
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lyophilisation and terminal sterilisation with ethylene oxide gas (ETO). Unprocessed allografts may be treated by gamm
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