Transport of biological samples and medicinal products
We are authorized by the Italian Ministry of Health to carry out the transport of biological samples for clinical use and research and we possess UNI ISO 21973 certification for the transport of cells for therapeutic use. We are partners of the IBMDR (Italian Bone Marrow Donor Registry) network, for international transport of stem cells and blood components from adult donators and hematopoietic stem cells from cord blood for transplantation purposes.
The transport of biological samples is fundamentally important to ensure the safety of the operators and the correct preservation and treatment of the sample to be transplanted or used for research purposes.
The transport conditions must ensure the maintenance of the stability of the sample and its diagnostic value, as these characteristics are necessary to ensure the reliability of the results of the tests to which the sample is to be subjected.
The time, temperature and methods of remote transport of biological samples and medicinal products are potential sources of corruption of the biological matrix, which has extremely serious consequences.
It is therefore fundamentally important that the transport of biological samples and medicinal products be commissioned to operators with certified reliability.
Bioshipping service
The Bioshipping service is dedicated to the transport of any type of samples within controlled temperature ranges:
- Ambient Temperature
- +15/+25°C
- +2/+10°C
- -40°C
- -80°C in dry ice or with mechanical refrigeration
- -150/-196°C in nitrogen vapor or liquid nitrogen.
The service comprises:
- Transport from one place to another with an operator on board and the use of controlled temperature containers with calibrated and certified data loggers;
- Complete support for the management of authorizations, health and customs permits;
- Management of sensitive data in compliance with the current Directives;
- Compliance with the national and international standards;
- Equipment certified as Medical devices and validated in accordance with ecGMP Annex 15;
- Final delivery of reports on temperature traceability and the position of each individual biological sample through all phases of transport;
- Management of sampling site networks for Clinical Trials;
- Supply and preparation of standardized sampling kits, in accordance with specific sampling and storage needs;
- Transport in accordance with the EN 33783 and ADR directives.