Telstar has developed three integrated production lines incorporating dosing, freeze-drying, unloading and packaging technologies for the manufacture of bulk sterile antibiotics for Hisun, one of the largest Chinese producers of active pharmaceutical ingredients (APIs).
This is said to be the largest integrated project to be carried out in China in which a single company provided all of the technology for the entire primary packaging process.
The integrated freeze-drying system features an automatic loading and unloading system operating under sterile conditions within a production isolator. Specifically designed for the freeze-drying of antibiotics, the system incorporates a sterile isolator, which protects the operator and provides an ISO 5 class manufacturing environment.
The first stage of the process (freeze-drying) is composed of three GMP production freeze-dryers and automatic tray loading and unloading systems installed inside sterile isolators, together with equipment to dispense the liquid product into trays.
After the freeze-drying cycle is complete, vacuum unloading systems move the freeze-dried product into IBC containers.
The project also includes steam autoclaves and various RAB (Restricted Access Barrier) and isolator systems necessary for other applications associated with the production process.
The second stage of the process involves weighing and packing support for each of the freeze-drying systems. An integrated autoclave is used to steam-sterilise aluminium canisters, which are then dosed from the IBC with a weighed quantity of the freeze-dried product. Packing then completes the process.
Telstar has supplied the complete system in triplicate, thereby giving the client greater flexibility in carrying out large-volume production.
