Capozzi, Luigi (2018) Freeze-drying methods and related products. US11340014B2.
Full text not available from this repository.Abstract
This technology uses a continuous manufacturing line to freeze-dry pharmaceutical formulations. To freeze-dry a drug, the samples are (1) loaded into vials, (2) frozen, undergo a two-step drying process of (3) primary drying and (4) secondary drying, then are (5) backfilled/stoppered. In traditional freeze-drying manufacturing, these steps are done in large batches and require manual handling between steps, which results in long dead times. This technology performs all of the freeze-drying steps in a fully automated, continuous manufacturing line that includes filling, freezing, drying, and backfill/stoppering modules. This continuous freeze-drying system has three major improvements over batch freeze-drying. First, the continuous freeze-drying process is up to 5 times shorter than a traditional batch freeze-drying cycle. Secondly, the continuous freeze-drying line is autonomous and internally sterile, which cuts down on labor and increases the safety of the final product since because samples do not need to be manually transferred between steps. Finally, since all the samples pass through the same path, the final products have greater uniformity than those produced using batch freeze-drying. In summary, this technology can greatly improve the quality and speed of manufacturing for lyophilized drugs and research reagents.