We are painstakingly scrupulous in planning our temperature-controlled storage capacities and making sure that they meet defined criteria, and we take the latest cool chain findings into account.

Design qualification (DQ) ensures that the materials and systems meet the required specifications for the cool chain management.

Installation qualification (IQ) documents proper technical installation of the DQ-based design in accordance with the required and legally specified safety standards.

Operational qualification (OQ) documents how the planned specifications will be maintained during operations. For example, temperature and alarm thresholds are set for defined conditions, and extreme and emergency scenarios are tested and documented.

Performance qualification (PQ) ensures that the system provides the required performance in conjunction with the room equipment at different degrees of capacity utilisation.

The basis for the last-mentioned type of optimisation is comprehensive temperature mapping with over 50 mobile data loggers. This procedure determines the coldest and warmest points in the cold storage facility, and therefore the installation sites for alarm sensors. The system controls are adjusted according to capacity utilization and keep the temperature between 2 and 8 °C. In case of power failure, an emergency power unit kicks in automatically to ensure continuous cooling of the pharmaceutical products and therefore a gapless cool chain.