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The Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) requires an Ultrasonic Package for Buchi Mini Spray Dryer S-300. Advanced pharmaceutical manufacturing is an innovative pharmaceutical manufacturing technology, which has the potential to enhance drug quality, improve the reliability and robustness of the manufacturing process and supply chain, and increase timely access to quality medicines for the American public. One of FDA's research priorities is to explore advanced manufacturing techniques, including manufacturing of spray dried powder for intranasal drug delivery. CDER requires an Ultrasonic Package for Buchi Mini Spray Dryer S-300 that can be installed on Buchi mini spray dryer S-300 and B-290. The ultrasonic nozzle should be capable of producing spray dried powders with ideal particle size for intranasal drug delivery (to produce particles up to sixty (60) microns).
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