T106 Terminal Sterilization System™ |
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Sterilization Background Human allograft tissue has historically been regarded as a safe grafting material with regard to disease transmission. Only unprocessed, fresh frozen allografts have been documented as sources of viral infection in bone graft recipients. |
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| Introduction Sterilization has been defined as the process or act of inactivating or killing all forms of life, especially microorganisms. According to the Association for the Advancement of Medical Instrumentation (AAMI), a standards-setting organization for the medical industry, sterility assurance level (SAL) is defined as the probability of an item being non-sterile after it has been exposed to a validated sterilization process. To achieve a SAL of 10-6, meaning that there is less than a 1 in 1,000,000 possibility of a contaminating organism surviving the treatment. Sterilization of musculoskeletal tissues has several inherent problems that were not overcome until recently. First, the biomechanical integrity of tissue can be significantly altered by heat and irradiation. Second, not all sterilants have adequate tissue penetration, especially gases and liquids. Without complete penetration, sterility cannot be assured. Third, musculoskeletal tissues are often contaminated with a large number of organisms (i.e., bioburden). For human allograft tissue to be considered sterile, it must achieve a SAL=10-6 as expressed in logarithms, i.e. exponents of 10. For example, 1 log reduction means 90% inactivation and 6 logs means 99.999% inactivation, with survival of less than one in 1,000,000 pathogens. A few processes being used today can achieve this type of reduction; however, no known process reaches “terminal” sterility without the use of low dose irradiation for all forms of allograft tissue until now. |
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| Patient Benefit Increasing the safety of human allograft bone grafts is of significant importance and of great benefit to patients. Often, the decision to use an autograft rather than an allograft tissue is based on the perceived risk of viral or bacterial transmission. Until now, very limited technologies have been capable of substantially reducing all types of pathogens in biological products, while maintaining the integrity of the underlying bioactive properties in the product. Various current sterilization and cleansing methods exist but can destroy limited or specific types of pathogens (such as bacteria or lipid enveloped viruses). Validated testing proves T106™ Terminal Sterilization System substantially inactivates these types of known pathogens, including Clostridium sporogenes a more common and resistant pathogen than C. sordellii, in allograft tissue products. |
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| UltraGraft™ Non-Irradiated Key Features | |
| • | Sterile implant offering complete confidence |
| • | Greater biocompatibility offering greater osteoinductivity and osteoconductivity |
| • | Greater structural integrity providing stronger more resilient implants |
| • | Validated sterilization method using the overkill method, the most stringent of validation methods |
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| Non Irradiated & Sterile allograft tissue is the next step in sterilization techniques. Increasing allograft performance and surgeon confidence is paramount… MORE |
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State-of-the-art manufacturing facility has its advantages. Building the latest in Cleanroom technologies in 2008, TissueNet facilities are second to none… MORE |
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| Faster Recovery & Peace of Mind was the driving factors in developing the Next Generation Allograft. Learn the benefits of UltraGraft™ in your surgery. MORE |
