PROCESS FOR CONTROLLING THE QUALITY OF A FREEZE-DRYING PROCESS

摘要

Method for controlling the quality of a freeze-drying process includes the steps of defining a set of experiments by statistical design of experiments; performing freeze-drying processes of a product for each one of the experiments; obtaining a dataset of pressures and temperatures from the freeze dryer, the dataset comprising at least one combined parameter; removing noise intrinsic to the measurements; performing a PCA to obtain a fingerprint of the lyophilization process for each one of the experiments; and selecting a range of fingerprints in which a specific product batch will be within specifications. Also provided is a process for controlling the quality of a freeze-drying process which comprises: performing the freeze-drying process at the temperature and pressure set points of the optimal process; obtaining a fingerprint of the process; and using the range of fingerprints obtained above to assess whether the product batch is within specifications.