Quality Management System
Fat: The Future of Natural Beauty - with Fat Grafting
We follow a rigorous protocol with every incoming and outgoing tissue sample. Here are the steps in our process:
1. UPON RECEIPT OF THE COLLECTED TISSUE TO THE T&CT LABORATORY, ALL RECEIVED SAMPLES ARE TESTED, ENSURING THE SAFETY OF THE PATIENT
- Sterility
- Microbiology
- Serology
- European Pharmacopeia
- Bioburden
- HBV, HCV, HIV, Treponema Palladium, HTLV-1,2
2. SAMPLES ARE FILTERED TO REMOVE OIL AND UNWANTED FLUID FRACTIONS, PURIFYING THE FAT WITHOUT DAMAGING THE CELLS
- Optimized process through a gentle spin centrifugation
3. SAMPLES ARE SAFELY STORED USING OPTIMAL PROCESSING FOR MAXIMAL VIABILITY
- Controlled freezing process to minimize cellular damage
- Cryogenic storage using liquid nitrogen at -196°C.
4. WE THAW AND SEND BACK THE REQUESTED AMOUNT OF TISSUE, PROVIDING BEST QUALITY TISSUE FOR GOOD GRAFT RETENTION
- Controlled thawing and processing of tissue and cells, ready for reinjection
- T&CT tests for sterility once more
- Thawed tissue delivered by specialized courier in our secure transport kit
- We safely transport the tissue within sterile medical-grade bags
- T&CT kits provide tissue quality up to 72 hours of transport
5. TISSUE IS DELIVERED TO THE CLINIC FOR REINJECTION
- The fat is delivered to the surgeon in our kit and is ready for reinjection; no processing is necessary
THE T&CT KITS MEET HTS REQUIREMENTS. Kits contain:
- all procurement and patient paperwork
- all materials and devices needed for tissue transport
- a data temperature logger to monitor any fluctuation
QUALITY AND REGULATORY MANAGEMENT
- HTA and GMP-compliant QMS Traceability
- Reporting of adverse events to the HTA*
- Post-market data analysis
- Clinical studies