Disaster recovery plan
Italian Legislative Decree No. 191 of November 6, 2007, implementing Directive 2004/23/EC on standards of quality and safety for the donation, procurement, testing, processing, preservation, storage, and distribution of human tissues and cells, requires the availability of an independent third-party organization capable of supporting laboratories and storage facilities in the event of catastrophic incidents, severe tank failures, or interruptions in liquid nitrogen supply.
In 2012, BioRep became the first private organization in Italy authorized by the Ministry of Health to provide third-party emergency transportation, storage, and preservation services for hematopoietic stem cells and reproductive tissues and cells as part of certified Disaster Recovery Plans.
BioRep possesses all the resources necessary to provide these services, including:
- Dedicated cryogenic facilities
- Backup cryogenic storage systems
- Dedicated monitoring and control services
- Specific validated operating procedures
- Specialized personnel available 24/7, 365 days per year
Tank handling and transportation are performed in full compliance with biological material transport regulations and UNI EN ISO 9001:2015 standards, utilizing ADR-compliant vehicles and drivers holding Professional Training Certificates (CFP).
Each emergency response plan is tailored to the specific needs of individual facilities in collaboration with Biobank Management teams.
The transfer of biological materials into dedicated cryogenic storage systems is executed according to the highest quality standards, ensuring maximum protection throughout every stage of the intervention.