STP1452

    Method to Determine Germicidal In activation in Allograft Processing

    Published: Jan 2004


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    Abstract

    Because the risk of disease transmission remains even though stringent requirements for selecting and screening allograft donors have been adopted, processing methods capable of sterilizing tissue are needed. This test method discusses a means of evaluating the efficacy of allograft processing methods to eliminate bacterial contamination within the matrix of cortical bone. A Bacillus stearothermophilus biological indicator is inserted into a cavity drilled into the cortex of a long bone and the bone is processed under different treatment methods. A similar set of soft tissue specimens was prepared by inserting the spore strip into the soft tissue matrix and stitching it closed. After treatment the spore strips are aseptically removed and evaluated for growth. This test method allows for the evaluation of sterilization processes of tissue-based products with complex matrices.

    Keywords:

    sterilization, allograft, allograft processing, disease transmission


    Author Information:

    Mills, CR
    Vice President of Operations, Manager of Process Research, and Manager of Product Sterilization, Regeneration Technologies, Inc., Alachua, FL

    Roberts, MR
    Vice President of Operations, Manager of Process Research, and Manager of Product Sterilization, Regeneration Technologies, Inc., Alachua, FL

    Chang, JY
    Vice President of Operations, Manager of Process Research, and Manager of Product Sterilization, Regeneration Technologies, Inc., Alachua, FL

    Bianchi, JR
    Manager and research engineer, Regeneration Technologies, Inc., Alachua, FL

    Summitt, MC
    Vice President of Operations, Manager of Process Research, and Manager of Product Sterilization, Regeneration Technologies, Inc., Alachua, FL


    Paper ID: STP11634S

    Committee/Subcommittee: F04.16

    DOI: 10.1520/STP11634S


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