Tissuenet - Allograft Tissue Specialists

T106 Terminal Sterilization System™
Sterilization Background Human allograft tissue has historically been regarded as a safe grafting material with regard to disease transmission. Only unprocessed, fresh frozen allograft's have been documented as sources of viral infection in bone graft recipients.

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 bio mechanical 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., bio burden). 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, T106™ is the only known process that reaches “terminal” sterility without the use of irradiation for all forms of allograft tissue. 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 bio active 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.

UltraGraft™ Patient Benefit Two Words: Safety and High Performance T106 Terminal Sterilization System™ was developed to address both of these issues when it comes to allograft tissue: First, is tissue sterilized to SAL=-6 (true sterility) after final packaging? Second, how do we preserve the tissue collagen and bio mechanical structure to increase performance of the graft? Both of these goals were achieved with T106™ through our proprietary cold chemical sterilization process performed in our certified Cleanroom's.

UltraGraft™ Non-Irradiated & Sterile Key Benefits
•	Sterile implant offering 100% confidence
•	Greater bio compatibility offering greater osteoinductivity (ability to induce new bone growth in patients) and osteoconductivity (provide new bone growth a scaffolding to grow into)
•	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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