Overview of the GraftShield® Process
Although the options for surgical musculoskeletal repair are expanding, surgeons are increasingly choosing bone and soft tissue allografts as a safe, effective, and convenient surgical alternative.
Our processing involves rigorous donor screening and recovery procedures, certified laboratory testing, validated tissue cleansing, sterile packaging, and a top-rate quality-assurance system.
The system sets a new sterilization standard, protecting each allograft’s biomechanical properties and reducing the risk of disease transmission.
Tissue Cleansing and Processing
Our proprietary system was developed to offer the following advantages:
- Reduction of bone marrow and lipid element associated with normal human tissue
- Custom machinery designed by THB to manufacture and sterilize tissue between each donor case
- Controlled exposure to freeze/thaw cycles
SteriGraft® bone and soft tissue allografts are packaged to preserve their validated sterility. Meticulous steps are taken to ensure the highest patient safety and allograft quality.
Our packaging has the following advantages:
- Outer package providing a moisture barrier for ultra-low and ambient temperature storage
- Sterile inner pouch designed for easy delivery to the sterile field
- Terminal sterilization of product in its final packaging
- Validated 3- or 5-year expiration dating
- Product insert with donor screening, testing, and tissue processing details
- Transplant record and tissue ID barcode labels
- SteriGraft® box for convenient storage
Our donor tracking, documentation, and tissue, packaging, and shipping processes ensure safe and high-quality allografts. The quality assurance staff and medical director perform a three-level pre-processing review of the following:
- Donor qualification
- Medical/behavioral risk
- Recovery process, refrigeration times, and recovery site
- Completion of recovery record
- Receipt of tissue
- Materials used in recovery and expiration dates
- Blood sample assessment
- Infectious disease testing results
- Microbiology results
- Information sharing with other agencies who participated in recovery or receipt of recovered tissues
- Pathology/autopsy results if performed
- Processing records
Our Processing Partner Facility
BBA has a state-of-the-art processing center in San Antonio, Texas, built in compliance with human tissue handling requirements.
Specialty features include
- Gasketed, sealed, and washable ceilings
- Full sheet glued Fiberglass Reinforced Polyester or modular, seam-sealed walls
- Magnehelic gauges for continuous monitoring of clean room zone pressures
- Fully adjustable HEPA filter system
- Ethylene oxide sterilization of supplies and equipment
- Steam sterilization of supplies and equipment