A subsidiary of Alamo Biologics
Precision Allograft Solutions is dedicated to honoring the gift of donation by providing a safe, extensive, and quality allograft supply to the medical community and patients to improve quality of life. To ensure safety, our products are manufactured to the highest statutory, professional, and legislative requirements. We are committed to providing controls for the prevention of nonconforming products, early detection of discrepancies, and corrective actions to ensure consistent delivery of quality products and services.
For a full list of our products and services, including contract manufacturing, please contact our Sales & Marketing Department at [email protected].
Precision Allograft Solutions is a leader in state-of-the-art cleaning and sterilization techniques. Pioneering the methodology using supercritical CO2, our proprietary PASCO2® technology offers a superior bio-compatible alternative to irradiation without compromising graft integrity (1).
PASCO2 technology utilizes supercritical CO2 to cleanse and sterilize allograft tissue. In its supercritical state CO2 can effuse through solids like a gas and dissolve materials like a liquid. PASCO2 technology balances pressure and temperature of SCCO2 extracting blood and lipids from the allografts. The low temperature of the process and the stability of CO2 allow compounds to be extracted with no damage or denaturing to the tissue. PASCO2 allografts are processed to a validated sterility assurance level (SAL) of 10-6 as recommended by the AATB and FDA.
It combines the principles of supercritical CO2 with that of traditional chemical and mechanical steps for the removal of organic materials, such as blood particles and lipids, from both hard and soft tissues. In addition to a highly effective validated washing procedure. PASCO2 technology utilizes a mild, non-toxic sterilizing agent, to thoroughly inactivate pathogenic microorganisms and achieve a Sterility Assurance Level of 10-6 while simultaneously maintaining biocompatibility as well as the physiological properties and mechanical integrity of the tissue. Trained surgical technicians in certified Class 100 clean rooms utilize this proprietary, validated process based on ISO 14937:2009 (sterilization requirements for Health Care products) to process donated human tissue into high quality PASCO2 allografts. Precision Allograft Solutions provides tissue crafted with exacting standards for use in a variety of surgical procedures
SCCO2 sterilized allografts exhibit biomechanical properties closer to those of natural tissues when compared to those treated with gamma irradiation.
Research has shown that allograft tissue sterilized using SCCO2 better maintain their elastic properties and strength as compared to tissue treated using other, more traditional, sterilization methods.
(1) Anastasia Nichols: Studies on the Sterilization of Human Bone and Tendon Musculoskeletal Allograft Tissue Using Supercritical Carbon Dioxide; J. Orthopedics 2009;6(2)e9