Lab Guidelines

Vital Cell Solutions uses only industry leading manufacturers of human cellular and tissue-based products (HCT/Ps).

ETHICAL TISSUE BANKING
AND MANUFACTURING

Our Cells that we offer use only top tissue bank labs to ensure the safety of transplant recipients, donors, medical practitioners, and hospital staff. As a tissue lab provider we are responsible for fulfilling the expectations of the tissue donors and the recipients through a strong ethical and regulatory practice.

Testing

Testing & Guidelines: We only work with companies that exceed industry standards for lot testing. Every lot manufactured is sent for sterility, endotoxin, and environmental testing by a third-party laboratory that is a global leader in pharmaceutical, cosmetic, and environmental testing.

USP 71 Sterility Guidelines (All Fungus, Mold, Yeast, Bacteria) in accordance with AATB and FDA guidelines.

Endotoxin guidelines and environmental testing in accordance with AATB and FDA guideUSP 1116 Environmental Controls in accordance with AATB and FDA guidelineses, blood, and tissue borne pathogens in accordance with AATB and FDA guidelines including HIV, HBsAg, HCV, HBc Total, HTLV I/II, RPR, HIV/HCV/HBV Ultrio, WNV NAT, CMV Ab, Zika NAT, Lyme Disease, Epstein-Barr Virus, E.coli, Candida, and COVID-19ocesspulation: Vitti LabsTM processes HCT/Ps in compliance with minimal manipulation guidelines to be regulated as a 361 HCTl tissue, minimal manipulation means that the processing of the HCT/P does not alter the original relevant characteristics of the tissue relating to the tissue’s utility for reconstruction, repair, or replacement following 21 CFR 1271.3(f)(1).

Original relevant characteristics of structural tissues generally include the properties of that tissue in the donor that contribute to the tissue’s function or functions.

* For a complete list of testing please contact your representative.