Greifswald University Medicine comprises two pharmaceutical manufacturing facilities for medicinal products, blood products, stem cell and CAR-T cell preparations. The blood products have to be frozen at -30 °C, and stem cells need to be cryopreserved at -80 °C. This means that the equipment and processes related to the preservation, storage, and transport of the products must be qualified and safely validated.

In order to extend the existing production authorization, Greifswald University Medicine must regularly demonstrate re-qualification of the equipment used at the sites in two-year intervals, as part of an audit by the authorities. As a certified CAR-T Cell Application Center, the hospital must also provide evidence of qualified automated machines for controlled freezing of the cells.

In this case study, you will learn how Greifswald University Hospital used a GMP-compliant, sustainable temperature monitoring solution to:

• create a uniform hardware and software solution for two manufacturing sites;

• allow for qualification of a new freezing machine for CAR-T cell therapy; and

• ensure future compliance through straightforward re-qualifications of all devices during the biennial audits by the authorities.