Patheon, a leading global provider of contract dosage form development and manufacturing services to the pharmaceutical and biotechnology industries, has recently completed a new ‘fast track’ project with GEA Lyophil.
The project, completed in one year from start of construction to product production, was to install new lyophilization equipment to develop an essential new product. According to the company the whole project was a great success.
Patheon’s development and manufacturing capabilities cover prescription and over-the-counter (OTC) products in solid, semi-solid and liquid dosage forms, as well as specialized capabilities in high-potency, cephalosporin, controlled/sustained release and sterile manufacturing, including aseptic filling and lyophilization. To meet production requirements the company had no option but to consider a fast track approach for its latest development project.
The usual procedure for installing lyophilization equipment would require the supplier to assemble components at its workshop, conduct the necessary Factory Acceptance Test (FAT), then take the equipment apart for transport to the factory for re-assembly and the Site Acceptance Test (SAT). This is a laborious and time consuming exercise.
Fast track order handling from GEA Lyophil is much quicker. It requires many activities to be transferred directly to the customer’s site. Components (chamber, condenser, shelf package, refrigeration system, etc.) are made by Lyophil and its suppliers, fully tested using highly qualified staff and then shipped to the customer. Assembly is performed by Lyophil or the customer’s staff under Lyophil supervision as requested. The integration of parts and final SAT all take place at the customer’s site.
Specifically, for Patheon, the fast delivery of the LYOVAC® freeze dryers was critical.
All other vessel components (i.e. evaporator, shelves, hydraulic cylinders) were fabricated to enable final assembly to be performed at Patheon, not GEA Lyophil. According to Ioannis Karanatsios from GEA Lyophil, it was teamwork that helped the project’s success. “It was important to maintain a close co-operation between us and Patheon,” he said. “We had regular meetings to make sure that potential problems could be identified early and managed effectively.” The meetings provided an opportunity for both project teams to discuss project plans and strategy and to take part in setting the schedule. “It was very important to find the right team members,” continued Ioannis. “They had to have the right expertise, get on well together and be committed to the project.
Fast Track is not necessarily less expensive than traditional project handling methods but it does provide a much shorter lead time allowing the final product to be available on the market much sooner. It delivers the same high quality as all Lyophil freeze dryers, including options such us CIP, SIP, Part 11 etc., and FDA inspections and approval.
Sergio Steffenoni is the European Engineering Director for Patheon who took charge of the engineering aspects of the project and construction. He explained that the fast track service from GEA Lyophil was the best option for them. “We had to bring this product to market quickly and fast track was the only option,” he said. “The whole project was completed between September 2005 and September 2006. The commissioning was completed in this time without any major problem.”
Asked whether he would consider using fast track from GEA Lyophil again he said that he would and that he had similar projects planned for the near future. “I think this procedure should become the norm for the pharmaceutical industry,” he said.
GEA Lyophil specialises in the supply of freeze drying equipment for the pharmaceutical and biotech industries. As a member of GEA Pharma Systems, a dedicated group of leading pharmaceutical processing brands, it h
as acces s to the combined technologies of: Buck for contained materials-handling; Courtoy for tablet compression; Niro for unique spray drying systems; and Aeromatic-Fielder and Collette for reliable granulation and drying technologies. The synergy created within the Group allows all its members to provide comprehensive processin g systems for solid and liquid dose manufacturing projects developed specifically to meet their customers’ needs.
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