When freezing BDS, it is not just a matter of bringing the substance to a target temperature. Rather, factors such as the freezing speed, uniform temperature distribution within the container and the control of supercooling and physical stress directly influence the stability and effectiveness of the product. Even slight fluctuations in the temperature profile can lead to structural changes in the molecule and thus have a lasting effect on product quality. A reproducible and validated freezing process is therefore essential - not only for product safety, but also for regulatory requirements and economic efficiency.
Refolution provides advanced freezing systems that enable fast and uniform freezing while ensuring complete control over the critical process parameters. The systems have a modular structure and are designed for both smaller volumes and large batches of up to 75 litres per unit. Thanks to integrated temperature recording and digital process monitoring, all freezing processes can be fully documented and validated. The compact design also allows seamless integration into existing laboratory or production environments, even under GMP conditions.
