We protect your patients' health, acting as a guarantee against biological risk
BIOKIBANK uses the WHO Laboratory Biosafety Manual as a reference and guide in its daily practice ensuring the its procedures, services offered and, above all, the samples do not infringe the safety of treatments, providing its collaborators with a significant level of safety for patient health, at the same time guaranteeing availability for clinical, research and epidemiological purposes.
To prevent any risk of biological contamination, a microbiological culture is carried out. If there is flora growth, we must destroy the samples obtained and processed that day and begin a disinfection and quarantine protocol throughout the laboratory.
Quality and control
BIOKIBANK and the Single European Code (SEC):
The Single European Code is a 40-digit identifier that, along with the documentation that comes in the shipment of the cells, must support their traceability and provide information about the key characteristics of these cells.
Samples and freezing:
BIOKIBANK distributes its samples in highly secure 0.5 ml Cryo Bio System straws, that have the CE marking and are heat sealed to prevent contamination and isolate them from the liquid nitrogen. The straws are stored in liquid nitrogen banks for cryopreservation at -196ºC, periodically cleaned and with monitored volume and temperature.
Quality management systems: ISO 9001
BIOKIBANK currently has the Quality Assurance Certification ISO 9001:2015 as a Semen Biobank for the collection and selection of samples with Code ES18/60286, with annual reviews and renewal every 2 years. BIOKIBANK applies this Management System guaranteeing optimum control throughout all processes.
To transport its samples, BIOKIBANK uses a tank of liquid nitrogen, in vapour state, approved for the shipment of biological samples for road, air and sea transport. When sent, this tank is protected by a sealed container designed to transport this type of approved tank, to limit handling and prevent any incidents.
Legislation and health authorisation
BIOKIBANK is part of EUROCAE and is included in the European Registry of Tissue Establishments for their activity with the code: ES006055.
We comply with European Directive 2004/23/EC and Royal Decree 1301/2006 on cell and tissue banks in quality systems and we are strictly committed to keeping our operations and protocols within the legal framework that regulates assisted human reproduction, fundamentally constituted by Law 14/2006, of 26 May, on assisted human reproduction techniques and Organic Law 15/1999 of 13 December on personal data protection.
In March 2022, the Basque Government's Department of Health and the Spanish Government's Ministry of Health renewed BIOKIBANK's health authorisation to operate for a further period of 4 years as a semen biobank.