Active Freeze Drying revolutionizes pharmaceutical lyophilization

Traditional tray/shelf freeze drying involves freezing material in individual vials on plates, making it difficult to ensure that all vials undergo the same process conditions, such as temperature and pressure. This approach often requires numerous temperature probes and time-consuming measurements.

In contrast, Hosokawa Micron’s Active Freeze Drying technology uses a single, closed vessel to aseptically freeze and dry the material. This method produces sterile bulk API, even in quantities as small as a few hundred grams. The closed-vessel design simplifies monitoring and ensures the homogeneity of the entire batch, significantly improving product quality.

The Active Freeze Drying system is capable of drying solutions, dispersions, pastes and wet solids. Successful applications include APIs, parenteral formulations, probiotics, and large-molecule products like PLGA and hyaluronic acid. The system features a jacketed and stirred dryer and a collection filter. The material is quickly frozen inside the vessel under agitation. The energy required for sublimation is applied through the jacket and efficiently distributed throughout the product by the stirrer, resulting in a fine, loose, free-flowing powder.

Hosokawa Micron's Active Freeze Drying system is meticulously designed for aseptic processing, ensuring product sterility throughout the entire process. The fully contained, single-vessel system eliminates contamination risks by maintaining a sterile environment from start to finish. The vessel's smooth, crevice-free design prevents bacterial growth, while sterile valves enable contamination-free material charging. After the drying cycle, the vacuum is broken using sterile gas, and the final dry powder is aseptically discharged into a sterilized container, which can be directly docked to a vial-filling machine. This process negates the need for additional containment equipment during the packing stage.

Cleaning and Sterilization

The system's integrated Cleaning in Place (CIP) and Sterilization in Place (SIP) processes make cleaning and sterilization straightforward and highly effective. Spray nozzles inside the drying chamber initiate the cleaning process after each batch, with SIP achieved using pressurized steam or vaporized hydrogen peroxide. High heat transfer rates ensure rapid drying times, while easy filling, discharge, and quick cleaning cycles contribute to increased throughput. The fully contained design minimizes manual intervention, eliminating the need for operatives in protective suits.