Patient safety is our highest priority

Allograft Safety

While the options for surgical musculoskeletal repair continue to expand, a growing number of surgeons worldwide choose bone and soft tissue allografts as a safe, effective and convenient surgical option. Allografts bearing the SteriGraft™ label fulfill the discriminating surgeon’s desire to extend extraordinary patient care. Our superior level of allograft processing begins with rigorous Donor Screening and meticulous Donor Recovery Procedures, Certified Laboratory Testing, validated Tissue Cleansing, Sterile Packaging, and a meticulous Quality Assurance & Documentation system that ranks second to none.

These combine to form the proprietary, GraftShield™ allograft processing system, designed to set an entirely new standard in allograft sterilization. This system offers scientifically validated tissue sterilization (validated to SAL 10-6 in accordance with ISO 11137-2 Method 1) which virtually eliminates the risk of bacterial disease transmission.

To learn more about the various certifications of Gencure® Allografts and Texas Human Biologics, please click here.

To download a PDF file of our catalog pages which discuss our GraftShield™ human tissue processing systems, please click here.


A meticulous donor screening system has been developed to assure that only uniform, high quality tissues will be recovered and processed.

  • Donor Screening and Review – An extensive donor screening process is conducted to review medical / social history. Only those donors that meet our standards and screening requirements are qualified to be accepted for donation. This rigorous screening process is performed in an effort to eliminate potential donors with risk factors, which may contribute to the transmission of infectious disease.
  • A meticulous donor screening system has been developed to assure that only uniform, high quality tissues will be recovered and processed.

Click here to learn more about our donor screening and processing standards.


In accordance with FDA regulations and AATB Standards, donor tissues are tested by laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and carefully analyzed using the latest technology in order to confirm that the donor is free from the following infectious diseases:

Click here to learn more about our laboratory testing process for donated tissues.


The Graftshield™ process makes improvements at multiple steps in the tissue processing system. Our processing partner, Texas Human Biologics utilizes a state of the art processing facility which makes the following steps possible.

  • Tissue Cleansing – To prepare for processing, tissues are sanitized using GraftCleanse™. This proprietary blend of cleansing compounds significantly reduces bio-burden and allows for an aesthetic, white appearance.
  • Sterilization – GraftShield™ utilizes a low dose radiation sterilization method that is validated in accordance with ISO 11137-2 Method 1. Terminal sterilization is achieved with allografts in their final packaging.
  • Custom Processing Machines – We have designed and built custom equipment that enables individual equipment sterilization between cases, thus eliminating the risk of cross contamination – a significant advance in the safety of processing human tissue allografts.
  • Allograft Performance – Each allograft is evaluated at the time of processing, packaging, labeling, and again just prior to release to ensure that high quality tissue is being made available for transplantation.

Click here to learn more about our allograft tissue processing approaches.


SteriGraft™ Allograft Tissues from Gencure® Allografts are sterilized in their final packaging to ensure the highest patient safety. Our packaging processes ensure allografts arrive in the surgery in the best possible condition to facilitate a successful transplantation.

Click here to learn more about our sterile allograft packaging.


To comply with the standards set out by the American Association of Tissue Banks (AATB) and the U.S. Food and Drug Administration’s (FDA), Good Tissue Practices, Gencure® Allografts, its processing partner (THB), and the various donor processing organizations we work with all are subjected to an extensive quality process.

Click here to learn more about our quality assurance programs.