Sep 24 2009
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.
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