Tissue Processing & Safety

AlloSource is committed to the safety of all donor tissue we process. We have been processing tissue for over 20 years and have not had one incident of disease transmission with our tissue. Complying with current industry standards for donor eligibility and processing is critical to ensure the ongoing safety and availability of allografts. Tissue banking practices are determined by the Food and Drug Administration (FDA), American Association of Tissue Banks (AATB) and Clinical Laboratory Improvement Amendments (CLIA).

  • AlloSource has an unparalleled safety record and at no time has there been a confirmed adverse event tied back to the use of AlloSource tissue
  • AlloSource is registered with the US FDA and compliant with all applicable regulations, including:
    • 21 CFR Part 1271, Human Cells, Tissues & Cellular and Tissue Based Products
    • 21 CFR Part 820, Quality System Regulation
  • AlloSource is accredited by the AATB and compliant with AATB Standards for tissue banking and compliant with all applicable state regulations and voluntary guidelines as required
  • Tissue received by AlloSource is recovered by organizations that comply with AATB requirements and comply with all testing requirements of the AATB and FDA
  • AlloSource is compliant with current CLIA standards
  • AlloSource maintains certification to ISO 13485 through BSI for oversight of our Quality Management System.
  • Our staff holds a variety of certifications, including Certified Tissue Bank Specialist (CTBS), CBSPD (for sterile processing), RAC (Regulatory Affairs), CPIM (supply chain certification through APICS), OSHA certifications, EMT, Paramedic and RN

Tissue Processing