The Telstar Group has developed an automatic system for the bulk production of freeze-dried APIs under isolated conditions.
The Group, headquartered in Spain, developed this technology for use in the US by a major global pharmaceutical company. As a result, Telstar is now able to implement systems 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 unloading of the solid form and automatic transfer to a storage hopper.
Telstar is also developing systems for downstream processing following freeze-drying and product unloading, where the dry product is dosed into aluminium canisters and operations are performed under aseptic conditions inside isolators.
For the bulk production of freeze-dried APIs, the company has produced 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 an exposure risk for operators, the system incorporates a containment isolator between the product and the operator that allows a level of operator exposure of less than 1µg/m3 to be maintained throughout 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 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 the sterile downstream process of transferring the solid, freeze-dried product to process stations where it is dosed into aluminium canisters under aseptic conditions within isolators.
The company uses its own resources to develop its equipment technologies and this project involved Telstar's freeze-drying technology centre, headquartered in Terrassa, Spain; containment technology centre, based in Dewsbury, UK; and loading systems technology centre, based in Bristol, US.