Hosokawa Micron Powder Systems (Summit, NJ) wants to be your pharmaceutical development partner. On Wednesday, May 19, the firm cut the ribbon on a 1,600 square foot cGMP laboratory for pilot-scale production and testing of pharmaceuticals. The new lab, named the Pharma-Tech Center, includes two processing suites, a clean equipment storage area, equipment washroom, material quarantine and release areas, analytical laboratory, and client conference area.
About 250 people on hand heard brief remarks by officials from Hosokawa, the City of Summit, and the State of New Jersey. An earlier technical session featured leading academic pharmaceutical researchers. In the audience were Hosokawa employees, customers from virtually every major New Jersey area-based pharmaceutical company, and the press. Lunch and a tour of the new facility followed the short dedication ceremony.
Companies will use the Pharma-Tech Center to produce small batches of drugs for clinical trials. More important, they will do so in the ultimate pharm equipment environment, with dozens of Hosakawa experts at their disposal. Hosokawa hopes the Center will serve as a magnet for designing and testing manufacturing processes, safety, and quality control in a real-world environment. Clients will have access to portable pharmaceutical design equipment for testing within a sanitary zone. This equipment will also be stored in a separate clean area to comply with cGMP standards.
Bepex flake crusher for low energy milling
The isolated Pharma-Tech Center uses separate air handling systems incorporating "once through air," with approximately 18 air changes per hour. The use of an on-site liquid nitrogen supply allows inert equipment operations when processing explosive materials. All design criteria for the equipment and facility have been designed with cleanability as an essential element. The Center will house Hosokawa Micron's most advanced machinery for milling, grinding, rolling, granulation, drying, compaction, bulk packaging, and of course particle reduction, Hosokawa's specialty.
Hosokawa's Alpine Fluidized Bed Jet Mill
Although the physical size of the new lab is small by pharmaceutical industry standards, its opening shows a strong commitment by Hosokawa to support its products and customers where it counts most -- new drug development. "The Center will be a place where entire processes will be simulated and demonstrated," said Gerhard Kepler, Hosokawa's vice president of technology. "I don't mean just the machines, but the entire process, from actual feed material to the final product." Kepler claimed the center is the only pharmaceutical laboratory in the world where drug developers can benefit from the technical know-how of a world-class machinery manufacturer. "Hosokawa Micron is known primarily as a manufacturer of powder and particle equipment, specializing in size reduction, mixing, and product handling. We will now be the single source provider of equipment and expertise to the industry."
Hosokawa operates seventeen technical centers worldwide dedicated to synthesis, analysis, and process testing. The Pharma-Tech Center is the only Hosokawa site - and perhaps the only machinery company laboratory in the world - dedicated to process development under cGMP conditions. "We are now the only process equipment provider to have a facility of this type, located in the 'medicine chest' of the United States, [central New Jersey]," Kepler said. Indeed the Center could not be located more strategically, with dozens of world-class pharmaceutical companies within a ninety minute drive of Summit. Pharmaceutical companies pump about $8 billion per year into the New Jersey economy, nearly half of that in salaries.
For more information: Lisa Ciesla, Hosakawa Micron Powder Systems, 10 Chatham Rd., Summit, NJ 07801. Tel: 908-277-9206.
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