Testing & Validation

High Standards Deliver Superior Products

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Testing and Validation

20% of every lot manufactured is sent for sterility and endotoxin testing by a 3rd party C.L.I.A. Certified laboratory. In addition, Vitti Labs utilizes Tunable Resistive Pulse Sensing (TRPS) for each lot and a biannual Characterization Report produced by external laboratories for transparency and validation.

Sourcing

Vitti Labs only accepts bio-ethically donated birth tissue from healthy consenting mothers who have passed a comprehensive medical background check, blood screenings, and are full-term, live, C-section births in the United States. In addition, Vitti Labs only works with tissue procurement organizations within the United States who use collection techniques that follow the AATB guidelines, prioritizing the health and safety of the mother and baby above procurement. Vitti Labs does this to strive to have a 100% FDA and AATB compliant supply chain, validated sterility, and the highest quality procurement.

Regulations

REGULATIONS

Vitti Labs is a registered Tissue Bank that implements and maintains quality and regulatory assurance in alignment with FDA regulations. Vitti Labs implements AATB (American Association of Tissue Banking) standards, follow GTP (Good Tissue Practices), GMP (Good Manufacturing Guidelines) and WHO (World Health Organization) protocols and procedures to meet all requirements.