TISSUELAB: TECHNOLOGY FOR HUMAN TISSUE BANKS
Tissuelab is an Italian company established in 2003 and authorised by CNT – Italian National Transplant Centre – to process human musculoskeletal tissues from donation, on behalf of Italian and European Tissue Bone Banks, and dermis for Skin Tissue Banks
Tissuelab products are human allografts processed according to National and European Guidelines and Directives (2004/23/CE; 2006/86/CE; 2006/17/CE, etc.) .) in a high-technology plant.
AS WE WORK
GMP: Production plant, quality system and management of the processing are in conformity to GMP standards for the manufacture of the pharmaceutical sterile products (Annex 1. – EC Guide Manufacturing Practice – Manufacture of Sterile Medicinal Products – 2008) with special reference to terminally sterilized products.
CLASSIFIED ENVIRONMENTS: the processing is carried out in environments with pharmaceutical requirements, and their classification is validated by particles counting, differential pressure, air turnover changes proportional to grade of areas by “at rest” and “in operation” microbiological controls with monitoring of air and surfaces and, operatively, by personnel, materials and product flow procedures.
SYSTEM AND EQUIPMENT VALIDATION: Process equipments, critical devices and building utilities are validated according to pharmaceutical standards by IQ protocols (Installation Qualification), OQ (Operation Qualification) and PQ (Performance Qualification). The equipments are: Biological Banks (-80°C), autoclave, freeze-dryer, milling-machine, laminar flow cabinets, cutting – machine, Computer Numeric Control machine, etc.
PROCESS VALIDATION: Tissuelab validated the sterilization/viral inactivation process, freeze-drying cycles and the tissue processing, the cleaning of equipments and environments and the steam sterilization cycles with specific standard loads.
TERMINAL STERILIZATION: Tissuelab products undergo a sterilization/viral inactivation in the final packaging by gamma irradiation at low temperature that guarantees the microbiological and viral safety demonstrated by convalidation studies. The sterilizing treatment is performed with strictly controlled conditions and it preserves biomechanical and biological properties of tissues. The sterility test is performed in accordance with European Pharmacopoeia for the sterile drugs.
BIOMECHANICAL AND BIOLOGICAL STUDIES: Biomechanical and biological properties of tissues are preserved by soaking tissues with radio protectant solution.
Database management system (S.A.P.) is used for the control of incoming raw materials and donations, of production flow, of intermediate and finished products. Traceability of each processing material, donations and products is always ensured.
MUSCULOSKELETAL HUMAN ALLOGRAFTS
Tissuelab manufactures a wide range of human musculoskeletal tissues:
• Freeze dried hard tissues (cortical and/or cancellous bone) in chips,
granules and powder of different size (0,5 cc, 1 cc, 2 cc, 5 cc…), struts, blocks, shafts, wedge,
iliac crest, and freeze dried soft tissues as fascia lata.
• Freeze dried demineralised bone matrix (DBM) in chips, granules, powder of different size (0,5 cc, 1 cc, 2 cc, 5 cc…), shafts and cube.
• Bone pastes and putties mixing the DBM with a carrier able to giving the right physical, chemical, and biological features to the product.
• High technology or customised bone segments, worked with high precision 3D-scanner and milling machine in according to indications of the surgeons.
• Frozen soft tissues as ligaments and tendons (patella, gracilis, tibialis, semitendinuos….)
DECELLULARIZED FREEZE-DRIED STERILIZED DERMIS
Tissuelab processes dermis for Skin Tissue Banks. The product is an excellent scaffold for the colonization of stem cells and is utilized for burns, as a filler for plastic surgery, in orthopaedic and dental surgeries and so on. Our processing guaranties an optimal decellularization reducing immunity reactions and the product is freeze-dried and terminally sterilised with a validated processing that preserves the integrity of elastic fibres.