BioKryo High level ISO-certified quality for the storage of biological samples
BioKryo stores valuable biological samples using unique storage methods. Innovative standards for long-term storage of biological samples and cryosamples linked with advanced automation and centralization systems.
In April 2013, BioKryo´s already GMP geared QM-system was successfully certified in accordance to ISO 9001:2008 by GZQ (Society for the Certification of Quality and Environmental Management Systems Ltd.).
Highlights resulting of the appropriate audit have been the very high level of competence shown by BioKryo´s employees as well as the quality of its infrastructure. As a Fraunhofer Institute for Biomedical Engineering (Fraunhofer IBMT) spin-off, BioKryo profits from IBMT´s top of the world belonging systems in the Biobank field. These combine innovative standards for long-term storage of biological and cryosamples linked with advanced automation and centralization systems like Fraunhofer Cryostorage Technology (FCT). With FCT, it is now possible to keep a stable temperature range below -140° C for cryosamples during the entire transport and storage process. Thus, each sample is kept at exact the same temperature from the freezing to the storing. In April 2013, BioKryo`s GMP aligned quality management system was successfully audited and certified according to the ISO 9001:2008 criteria by the GZQ (Society for the Certification of Quality and Environmental Management Systems Ltd.).
This certificate depicts a further proof of the high quality of BioKryo`s services. The auditors of GZQ highlighted the high level of expertise of the BioKryo team. BioKryo GmbH offers the cryostorage of therapeutically valuable biological material such as cells or tissue samples on-site Sulzbach / Saar. As a spin-off of the Fraunhofer Institute for Biomedical Engineering (IBMT), BioKryo profits by IBMT's over ten years of experience in cryogenics and stem cell research. BioKryo holds a authorization according to § 20c AMG for the storage of such therapeutic tissue or stem cell lines, providing a GMP-compliant storage of medicinal products. BioKryo has the ability to plan and manage the whole logistic and transport process of biological samples, from a detailed preparation and handling of all formalities to the implementation of the transport as well as a comprehensive sample management, documentation and archiving.
The stored samples are constantly ready for the return to the customer or any place in Europe required by the customer, in case of future diagnostic and therapeutic applications needed. With a comprehensive quality management system, BioKryo continually optimizes its internally structures and processes. Thus, on one hand it meets their own customer focus and on the other hand it matches to all legal and quality requirements in regard to the transport and the storage of biologically valuable materials using cryogenics.