Frozen Osteochondral Allograft Criteria

JRF Ortho makes every effort to ensure the quality and safety of our grafts. Cleaning, processing and preservation procedures for frozen allograft tissues are designed to provide safe, high quality allografts.

Processing and Sterilization

To minimize potential contamination from the donor, environment, personnel or equipment, all tissue is processed in ISO Class 5 clean rooms. Processing is performed utilizing aseptic conditions and graft sterilization is achieved through validated processes which ensure the absence of bacteria in accordance with the United States Pharmacopeia (USP) and provides a Sterility Assurance
Level (SAL) of 10-6.

Rigorous donor screening that includes complete medical social history and physical examination
Rigid recovery procedures performed by highly trained surgical technicians using aseptic technique in a controlled environment
Extensive donor testing in accordance with AATB and FDA guidelines
Highly trained processing technicians
Aseptic environment and processing techniques
Robust cleansing process reduces or eliminates bacteria, marrow elements and lipids
Includes a series of disinfecting and cleansing rinses, centrifugation and sonication
Employs a combination of detergents and traditional treatments such as alcohol, hydrogen peroxide and antibiotics
Ultra-low dose gamma irradiation (0.9 – 1.5Mrads) in final packaging at low temperature to achieve tissue sterility without impairing the biomechanical integrity of the grafts
Sterile tissue has an SAL of 10-6
No donor pooling or batching
Packaging is clearly labeled with expiration date and storage instructions

Microbiological Testing

Laboratories that perform testing on behalf of the JRF Ortho are CLIA-certified.
Testing includes microbiological evaluations during processing and final packaging, as well as environmental and water quality monitoring.
Donated bone and tissue are cultured either at the time of recovery or during processing.
Swab cultures are obtained from each tissue prior to exposure of the tissue to antibiotics, disinfectants or cleansing agents.
Cultures are incubated in two types of media at two temperatures for a minimum of 7 days.
Destructive and fluid extraction cultures may be taken and incubated for up to 14 days.
If any of the cultures demonstrate microbial growth, the tissue is sterilized or not released for transplant.
Any aerobic or anaerobic bacteria detected are identified to the Genus level.

Environmental Monitoring

Our environmental monitoring program utilizes a combination of RODAC touch plates, viable air particle counts, non-viable air particle counts and settle plates.

Water Quality Monitoring

All water used in processing is routinely monitored for microbial content, water quality changes, conductivity and total organic carbon content.

Preservation and Storage

Frozen allograft tissues are frozen in ultra-low temperature freezers set at -80°C. Allografts are packaged in peel pouches and maintain a five year shelf life when stored at or below -40°C. Frozen allografts may be stored between -40°C and -20°C for up to six months.

Updated on: 16/03/2021