Telstar develops three integrated lines for bulk production of potent sterile antibiotics for ...

Chinese firm Zhejiang Hisun Pharmaceutical Co. Ltd. is a major international

manufacturer of APIs (Active Pharmaceutical Ingredients)

 

Telstar develops three integrated lines for bulk production of

potent sterile antibiotics for hisun pharmaceutical

 

This is the largest integrated project using proprietary dosing, freeze-drying, sterilisation, unloading and packing technologies.

 

Terrassa (Barcelona) 2012, September 7^th.Telstar 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, one of the largest Chinese producers of APIs (Active Pharmaceutical Ingredients).

 

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 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-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.

 

Hisun

 

Zhejiang Hisun Pharmaceuticals Co. Ltd is a Chinese company manufacturing high-value pharmaceuticals for the Chinese market and other regulated markets, including the USA. Hisun has become a leading API Active Pharmaceutical Ingredient manufacturer in China and today manufactures products covering antitumor, anti-inflammatory, cardiovascular, endocrinous, central nervous system, and veterinary drugs. The company holds a decisive position in the international market in terms of the production of statins APIs and anthracycline antitumor antibiotic APIs.  

 

Founded in 1956, the company started its business as an API provider and gradually expanded its business scope to domestic and international pharmaceutical markets and also to providing animal healthcare products. Presently, HISUN is intensifying its efforts in the R&D of genetic engineering drugs and innovative drugs. In 2010, Hisun was recognized as one of the ’Top 10 Enterprises‘ of ZheJiang Medicine Industry, and included in the ’Top 10 Industrial Enterprises of Optimum Product Lines in China’ Hisun was also awarded the ’Golden Bee Prize for Growing Enterprises‘. Located in Taizhou Zhejiang, Zhejiang Hisun Pharmaceutical Co. Ltd., has about 3000 employees.

 

Telstar

 

Telstar is an international leader in the development of high-technology global solutions for the pharmaceutical and biotechnology industries. Acknowledged as one of the 10 major suppliers for the pharmaceutical industry, the company is the only international manufacturer able to offer integrated process solutions for the pharmaceutical industry with in-house sterilisation, freeze drying, containment and clean air technologies.  Telstar invests 3% of its turnover in research, development and innovation of its technologies and equipment.

 

Telstar operates in over a hundred countries and has 7 production plants, 9 technology centres and 12 consulting and engineering services centres, and commercial offices all over the world. It has manufacturing plants in Spain, China, the United States, the United Kingdom, France, the Netherlands, Germany and Estonia. Headquartered in Terrassa (Barcelona), it has a workforce of 900 people.