29/10/2009Telstar to install in China an integrated automatic system for the production of antibiotics

• The integrated automatic system is designed for the bulk production of sterile and toxic antibiotic

• This is the largest integrated project to be carried out in China in which a single company, Telstar, provides all of the technology and the entire production process

The Telstar company is to develop a complete, integrated automatic system for dosing, freeze-drying, unloading and end packing of bulk sterile antibiotics for one of the largest Chinese producers of antibiotics and oncological products.

The integrated freeze-drying system will feature 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 allows an ISO 5 class manufacturing environment to be maintained. Production operations are carried out by robotic devices inside the isolator so the risk of contamination during human manipulation of the product are eliminated, while the operators are also protected from the toxicity 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 three-chamber 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 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 will supply this complete system in triplicate, thereby giving the client greater flexibility in carrying out large-volume production. 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.

The implementation of such a complex integrated project is made possible by close collaboration between Telstar's technological centres: freeze-drying, with headquarters in Shanghai (China); sterilization, based in Granollers (Spain); containment, based in Dewsbury (UK); and loading systems, based in Terrassa (Spain).  Telstar will integrate together all of the system elements in its in Chinese headquarters, thereby enabling the client to directly participate in the construction and test of the system.

Through this project, Telstar has become the only international company capable of offering a complete, integrated aseptic dosing, freeze-drying, unloading and packing system for the pharmaceutical industry that utilizes in-house technology and provides a complete production process.