Telstar, an international leader in the development of high-technology global solutions for the pharmaceutical and biotechnology industries, has successfully developed three integrated production lines incorporating proprietary dosing, freeze-drying, unloading and end packing technologies for the manufacture of bulk sterile antibiotics for Hisun Pharmaceutical, one of the largest Chinese producers of active pharmaceutical ingredients (APIs).

This is the largest integrated project to be carried out in China in which a single company, Telstar, 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. Production operations are carried out by automation systems inside the isolator so the risk of contamination during human manipulation of the product is eliminated, while the operators are also protected from the potency of the product.

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 restricted access barrier (RAB) 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-sterilize aluminium canisters, which are then dosed from the IBC with a weighed quantity of the freeze-dried product. Packing then completes the process, all of which will operate within an isolator to guarantee operator safety and ISO 5 classification.

Telstar has supplied this complete system in triplicate, thereby giving the client greater flexibility in carrying out large-volume production. Also designed into the system is the possibility to expand the production in the future by incorporating new freeze dryers and sharing much of the existing equipment.  Telstar's capability to develop and manufacture this system entirely in-house provides the client with a cost-effective solution and assures quality control over the whole process.

Zhejiang Hisun Pharmaceuticals Co. Ltd is a Chinese company manufacturing high-value pharmaceuticals for the Chinese market and other regulated markets, including the USA.