Allograft Safety

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The GraftShield™ allograft processing system is 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. The following paragraphs provide information on the tissue processing steps in this system.

To learn more about the various certifications of Bone Bank Allografts, please click here.

To download a PDF file of our catalog pages which discuss allograft processing, please click here.

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Tissue Processing

 

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GraftCleanse™ Tissue Cleansing

The GraftShield™ process requires aseptic handling of all tissue throughout processing and is based on a scientifically validated sterilization method which results in a Sterility Assurance Level (SAL) of 10-6 in accordance with ISO 11137-2 Method 1. This validated process is designed to protect the biomechanical properties of each allograft while virtually eliminating patient risk.During processing, tissues are treated with the GraftCleanse™ process which includes chemical and physical cleaning procedures that reduce the bone marrow and lipid elements associated with normal human tissue.

Tissue Processing

Our proprietary GraftSheild™ processing system was developed to offer the following advantages:

  • Validated GraftCleanse™ tissue cleansing method
  • Custom machinery designed exclusively for tissue manufacturing and sterilization between each donor case
  • Load strength testing
  • Controlled exposure to freeze/thaw cycles

Our Processing Partner Facility

Located in the Texas Research Park in San Antonio, Texas Human Biologics (THB) has recently opened its new state-of-the-art human tissue processing center. The facility was designed and built to be in full compliance with environmental condition requirements for handling human tissue. All human tissues are handled in an ultra clean environment.

 
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The GraftShield™ Advantage

  • Sterile human allograft tissues
  • Final package sterilization
  • Proprietary cleansing processes
  • Bone Bank Allografts meets FDA regulations and AATB standards