

The results achieved to date demonstrate that, with the right processing methods, homologous tissues retain their original hemodynamic, inductive, conductive and elastic properties, and can be considered an ideal material. All the operations involved in the tissues’ preparation, manipulation and preservation are completed in an environment and with equipment that conform to the Italian national guidelines.
The processing activities are conducted at the laboratory with a specified air quality and cleanliness in order to minimize the risks of contamination. The air quality has numbers of airborne particles and numbers of microbial colonies corresponding to grade A in the European Guidelines on Good Manufacturing Practice (GMP). The efficacy of the procedures involved is validated and certified. Access to the rooms where the tissues are processed is restricted exclusively to the personnel involved or to visitors accompanied by in-house personnel. Access requires specific clothing to enable any contamination from outside to be reduced to a minimum and to ensure personal safety. There are procedures in the Tissue Bank’s Quality Manual on the topics of incoming materials and personnel.

