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Results thus far obtained show that when correctly processed, homologous tissues are excellent material for implantation, maintaining their original haemodynamic, inductive, conductive, and elastic properties. All procedures regarding the preparation, manipulation and preservation of tissues are carried out in certified facilities in compliance with national regulatory guidelines.
All laboratory work is performed in an environment that meets the strict standards demanded for environmental air quality in order to minimise the risk of contamination. Laboratory air quality, defined in terms of the number of particles and microbial colonies it contains, is equivalent to Grade A of the European Guide to Good Manufacturing Practices (GMP). The efficiency of all procedures is validated and certified.
Entrance to the processing laboratory is strictly limited to specialized staff. All visitors must be accompanied. Anybody entering has to wear special clothing to minimize any possible contamination from outside and, of course, adequately safeguard laboratory technicians.
Recent decades have been marked by enormous strides in successful transplantation of tissues and cells thanks to advances in cell culture techniques and cryo-biology (biology at very low temperatures of -800C and -1600C). It has been shown that frozen or cryopreserved homologous tissues maintain their original haemodynamic, inductive, conductive and elastic properties and so, can be considered excellent transplantation material.
On arrival at the Tissue Bank, each donation is attributed an ID code by specialist personnel. This allows every tissue specimen to be traced. After the packaging and documentation have been verified, the following tests are carried out on the incoming material:
• Morphological assessment before processing starts and again before distribution. Each tissue is given a quality score according to a previously defined grading system;
• Disinfection with antibiotic solutions. Radiation treatment is not used in order to avoid tissue damage;
• Growth cultures are established to identify aerobic and anaerobic bacteria, mycetes (fungus) and mycobacteria.
These tests are carried out during all processing phases.
Donated tissues are processed by laboratory personnel on the basis of their possible subsequent use. Processing takes place in laboratories certified class A and B.
Storage techniques will depend on the tissue type and are:
Cryopreservation (-160°C). This is a long-term preservation technique that ensures that most of the cells’ functions remain intact. After processing, the tissue is plunged into a cryopreservant solution. To avoid hyperosmolarity shock, which would damage cells and jeopardise their viability, tissues are first placed in polyethylene bags. The nitrogen vapour storage tanks are kept at a constant temperature. Tissue preserved in liquid nitrogen subsequently presents lower immunological responses. In fact, the histocompatibility receptors of thawed tissue previously stored at -1600C are considerably reduced
Freezing (-800C). After processing, tissues are preserved at -800C without the use of cryopreservants, thereby eliminating cell components that could cause adverse recipient reactions on implantation. Bone tissue used as a filler in bone reconstruction as well as large bone segments are also preserved at -800C
Freeze-drying. The freeze-drying plant, the method used and its quality control system all comply with Good Manufacturing Practices standards used in the production of sterile pharmaceuticals (Eudralex Vol. 4 Medical products for human and veterinary use: Good Manufacturing Practices – Annex 1 – Manufacture of Sterile Medicinal Products).
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