Licensing

The consent process

The consent process is approved by the Human Tissue Authority. In house experts on tissue donor selection and medical history influence the standard across all donation programmes (blood, tissue and organ).

The standard

The standard is written by UK blood services in compliance with SaBTO (the Advisory Committee on the Safety of Blood, Tissues and Organs). Much of the standard is above and beyond the minimum required by European/UK legislation and regulation. Tissue Services was previously licensed by the MHRA (Medicines and Healthcare product Regulatory Authority) under the UK voluntary Code of Practice and now holds the mandated establishment licences under the HTA (Human Tissue Authority).

Service and facilities

The services and facilities (including pharmaceutical grade clean rooms) comply with Good Manufacturing Practice. All aspects of the supply chain from public education through to donor selection, donation, processing and supply are managed in house by our staff. Processes have been validated in-house by the Tissue Development Laboratory. All microbiology testing is performed in-house by accredited laboratories specialising in screening donors and donations.

Final donor assessment

Final donor assessment and selection is undertaken by in-house clinical specialists in tissue donation. Donations are tracked by barcode including automated test result transfer to the tissue database (the same database used for blood donation, processing and supply). This database has automated controls to prevent release of non-conforming tissue. Tissue is either stored at -80°C to ensure continued storage below the required -40°C, in gas phase liquid nitrogen to ensure storage below -135°C, or is freeze dried to <0.5 aW (water activity) which equates to <5% moisture.

All tissues are stored and moved with full audit trail determining stock location. Irradiation is carried out to an established protocol ensuring a minimum dose of 25kGy is received by the tissue. All processed tissues are non cytotoxic as per ISO 10993-5. All activity is regularly reviewed against practice considered best by international standards, with professional links to the British, European and American Tissue Banking Associations.