New Integrated Equipment for Bulk Production of Freeze-Dried APIs

The Telstar Group has developed an integrated automatic system for the bulk production of freeze-dried APIs under isolated conditions. Through this technology, developed for use in the USA by one of the major global pharmaceutical companies, Telstar is now able to implement solutions that combine in-house freeze-drying and containment technologies with those of automatic handling of trays of product. The system features automatic dispensing of the liquid product, the subsequent unloading of the solid form and automatic transfer to a storage hopper. Telstar is also developing solutions for the downstream processing following freeze-drying and product unloading, wherein the dry product is dosed into aluminium canisters, with all operations being performed under aseptic conditions inside isolators. For the bulk production of freeze-dried APIs, Telstar has developed a complete freeze-drying system with automatic handling of product trays under aseptic conditions, integrated into a containment isolator. Specifically designed for the freeze-drying of materials such as polypeptides, the handling of which can involve a exposure risk for operators, the system incorporates a containment isolator between the product and the operator which allows a level of operator exposure of less than 1μg/m3 to be achieved and maintained throughout the course of an eight-hour shift. The isolator’s main chamber, of vertical laminar flow, contains the mechanisms that automatically feed and extract the product trays from the freeze-dryer chamber. The system features two independent TSCs (Tray Storage Carts); one connected to each side of the main chamber of the isolator, where the product trays are stored once the freeze-dried product has been unloaded. Following the freeze-drying process, the dry product is removed from the trays using a vacuum system, which transports it to a cyclone where it is separated from the airstream and collected in a hopper, to be transported to the next step in the production process. In the second phase of the project, Telstar will incorporate into this piece of equipment the sterile downstream process of transferring the solid, freeze-dried product to process stations where it is dosed it into aluminium canisters; all under aseptic conditions within isolators.