CRYOLAB SOLGROUP
Servizi

WHAT WE DO

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.

  • Short, medium and long-term storage of cells, tissues, gametes, zygotes, embryos and gonad tissues as allowed by law 40/2004
  • Management of Disaster Recovery Plans
  • Transport of gametes: zygotes, embryos and gonad tissues on dedicated vehicles with specifically trained operators

DISASTER RECOVERY PLAN MANAGEMENT

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:

  • the provision of a dedicated toll-free number;
  • the activation of a structure of SOL technical operators available 24/7;
  • the use of dedicated means of transport, equipped with systems for tracking temperatures during transport and containers for refilling with liquid nitrogen;
  • a dedicated and shared Standard Operating Procedure.
GESTIONE DEL DISASTER RECOVERY PLAN

SHORT, MEDIUM AND LONG-TERM STORAGE OF BIOLOGICAL SAMPLES

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.

TRANSPORT OF BIOLOGICAL SAMPLES FOR RESEARCH USE

Cryolab offers to Centres on demand:

  • Point-to-point transport with a biologist on board using controlled temperature containers with data loggers.
  • Delivery of traceability reports on the temperature of the biological sample during transport.
  • Management of a network of withdrawal sites
  • Standardized withdrawal kits to meet the specific needs of withdrawal or storage
  • Dedicated dispatch using selected couriers.
  • Management of fast courier deliveries using prepaid transport documents with barcodes.

PATIENT SERVICES

Transport of gametes and embryos all over the world

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 Cryolab biologist on board and respects well-defined standards in all phases and critical points of the intervention:

  • the withdrawal of biological material from IVF Centers or individual patient
  • transport and storage in cryobiological containers
  • maintenance of safety standards for biological material and transport staff
  • traceability of temperature in all transport phases

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).

LABORATORY SERVICES

Full support for biostorage and cell manipulation

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:

SERVIZI AI LABORATORI

  • the management, also for third parties, of biological resource centers and research infrastructures for the manipulation and storage of biological samples, meeting international standards and guidelines and collaborating with your experts to obtain a technologically avant-garde structure;
  • support for researchers in the development of research projects and the preparation of clinical/treatment protocols;
  • on-job training with specific courses, seminars and operative stages;
  • design and execution of the microbiological contamination plan/program;
  • drawing up of SOPs for cell manipulation (minimal/extensive) and SOPs for the cryoconservation of biological samples;
  • Support in the carrying out of cell manipulation (minimal and extensive) and cryoconservation of biological material, thanks to staff highly qualified in cell therapies and cryobiology;
  • management and training of laboratory personnel/staff and coordination of withdrawal and collection points;
  • Citofluorimetry and haemometry services;
  • planning (URS, FS, DQ, SOP) of GMP classified environments (Clean Room, Cell Factory) by our engineering staff;
  • testing (IQ, OQ and PQ) of operational apparatus.
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