CryoLab is authorised by the Ministry of Health (protocol N° DGPRE 0022082-P-04/10/2013) to carry out highly specialised activities for Tissue Institutes and In Vitro Fertilization Centres.
The 2004/23/CE directive defines quality and safety regulations for the donation, supply, control, processing, conservation, storage and distribution of human tissues and cells.
Every cryobank requires a third party, authorised by the National Transplant Centres, to step in in the case of temporary unavailability of laboratories and/or storage areas following unexpected catastrophic events, permanent or serious damage to one or more nitrogen tanks or the interruption of the liquid nitrogen supply for various reasons.
CryoLab has the approval of the Italian National Transplant Centre to carry out support activities in the Disaster Recovery Plan regarding cryobanks, Tissue Institutes and biobanks for therapeutical use.
These activities include:
Cryolab is involved in the conservation of biological samples, the management and maintenance of cryobiological containers, with solutions for storage in liquid or gaseous nitrogen and mechanical freezers.
The storage of cryo-preserved products takes place in unequivocally identified and traceable conditions in cryobiological containers and in a way that eliminates risks of cross-contamination.
The temperature of the cryogenic containers is continually monitored and recorded, with remote alarm systems and emergency plans.
Telematic control of instrumentation is also guaranteed and all the data relating to the cryobiological room are periodically saved with rigorous redundant backup systems in separate rooms, and the data are saved on the SOL server for at least 30 years, as laid down by the most recent legislation.
The high quality of the service offered by CryoLab is ensured by continuous control of processes and instruments, together with high-level training for cryobiology laboratory personnel and the programming of periodical internal inspections.
Cryolab offers to Centres on demand:
CryoLab is authorised by the Italian Ministry of Health (protocol N° DGPRE 0022082-P-04/10/2013) to carry out, among its activities for In Vitro Fertilization Centers, the "transport of gametes, embryos and samples for clinical use, zygotes, embryos and gonad tissues, using dedicated vehicles with specifically trained operators".
Transport of biological samples is carried out by the branch of CryoLab specialized in national and international transport with UNI EN ISO 9001:2008 certification, using drivers with Professional Training certificates and vehicles equipped according to ADR regulations.
Biological material transport is carried out with a highly specialized operator on board and respects well-defined standards in all phases and critical points of the intervention:
The containers for transporting biological material in nitrogen vapour or liquid nitrogen are all sterilized and checked according to GMP Annex 15.
Validation data are collected by continuous monitoring of the container.
CryoLab manages any sensitive data acquired in line with Decree n. 196 of June 30th 2003. The Guarantor for the Protection of Personal Data was notified on March 21, 2013 (C.U.N. code 0000-0324-3149-9915).
CryoLab is the translation in the clinical and scientific research sector of service provider or facility management, applying these concepts to the fields of Translational Medicine, Molecular Biology, Biotechnologies, Regenerative Medicine, Manipulation of cell concentrates and stem cells and, more generally, Biobanking and Cryobiology.
Thanks to the experience it has built up and to the partnership with SOL SpA, CryoLab is at your side to offer you the best solutions for:
