AMPAC Fine Chemicals Validates Continuous Extraction Process for API Manufacture
Wed Sep 23, 11:33 AM
RANCHO CORDOVA, Calif., Sept. 23 /PRNewswire-FirstCall/ -- AMPAC Fine Chemicals (AFC), a subsidiary of American Pacific Corporation (Nasdaq: APFC), announced today the successful installation, qualification and validation in a cGMP manufacturing environment of a continuous extraction process consisting of three Hastelloy(TM) Liquid-Liquid Centrifuges (LLC) in series. These LLCs are used for the manufacturing of an Active Pharmaceutical Ingredient and replace a labor-intensive traditional batch extraction process. The modification to the existing process was conducted with the approval and the collaboration of AFC's customer.
"The LLC process improvement was demonstrated last year at bench scale by the R&D group and was transferred to commercial scale this summer," said Richard Beatty, Vice President, Product Management. "This change in the process is a major milestone in achieving an increased throughput by removing a volumetric pinch point in the overall process. As a result we could increase the batch size significantly and thus reduce costs."
"The validation was straight-forward and the resulting product exceeded expectations," said Joe Campbell, Director of Engineering.
"AFC has a long tradition of continuous process technologies that have been developed throughout our history of handling hazardous chemicals. We have been doing continuous chromatography at commercial scale for 10 years and earlier this year we opened a kilo facility dedicated to continuous processes. The implementation of these technologies for the manufacturing of APIs is the result of AFC's commitment to continuous processing. We expect to see more commercial scale continuous processes in the next few years," said Aslam Malik, President of AFC.
ABOUT AMPAC FINE CHEMICALS LLC
AFC is a U.S.-based company with demonstrated capabilities in process development, scale-up, and cGMP-compliant commercial production of active pharmaceutical ingredients (API's) and registered intermediates for pharmaceutical and biotechnology customers. Its specially engineered facilities and experienced staff allow AFC to safely produce highly energetic compounds at commercial scale. In addition, AFC's other technology platforms include production of highly potent compounds, continuous processes and industrial-scale chromatographic separation using simulated moving bed chromatography (SMB).
ABOUT AMERICAN PACIFIC CORPORATION
American Pacific Corporation (AMPAC) is a leading custom manufacturer of fine chemicals, specialty chemicals and propulsion products within its focused markets. We supply active pharmaceutical ingredients and advanced intermediates to the pharmaceutical industry. For the aerospace and defense industry we provide specialty chemicals used in solid rocket motors for space launch and military missiles. AMPAC also designs and manufactures liquid propulsion systems, valves and structures for space and missile defense applications. We produce clean agent chemicals for the fire protection industry, as well as electro-chemical equipment for the water treatment industry. Our products are designed to meet customer specifications and often must meet certain governmental and regulatory approvals. Additional information about us can be obtained by visiting our web site at www.apfc.com.
SOURCE American Pacific Corporation




