Allograft Possibilities

Safety

AlloSource’s number one goal is to provide safe, high-quality allografts. Accordingly, our recovery standards, screening and processing procedures comply with FDA and industry body guidelines. There has never been a confirmed incident of disease transmission from AlloSource tissue.

AlloSource safety credentials and procedures:

• Accredited by American Association of Tissue Banks (AATB)
• Clinical Laboratory Improvement Amendments (CLIA) certified testing laboratory
• Fully compliant with the FDA’s current Good Tissue Practices (cGTP)
• Tissue processed in ISO Class 5 clean rooms with HEPA filters and environmentally/microbiologically monitored air
• Equipment, instruments and packaging meet standards for sterility
• Extensive verification of a donor’s medical/social history and comprehensive physical assessment identifies and eliminates high risk donor tissue.
• A validated bioburden reduction cleaning process.
• AlloSource allografts are sealed in sterile pouches and clearly labeled with a unique donor and tissue ID, product ID code, allograft description, size, expiration date and storage instructions.
• Proprietary SterileR® process assures AlloSource allografts are sterile to 10^-6 sterility level
• 139 team members CTBS (Certified Tissue Bank Specialist) designation

An independent Medical Advisory Board is responsible for reviewing safety and quality procedures. The Medical Advisory Board, chaired by AlloSource Medical Director Ross Wilkins, M.D., is comprised of physicians specializing in orthopedics and tissue transplantation.