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Pharmaceutical manufacturing has traditionally been performed using batch process techniques that have been proven over many decades of use, but can have shortcomings when it comes to efficiency, quality control, and safety. Federal regulatory agencies have long supported the use of continuous flow chemistry in pharmaceutical manufacturing, and in recent draft guidance (1), the FDA stated that the adoption of continuous flow manufacturing is a foundation for improving the overall quality and availability of products.

“Continuous manufacturing can improve pharmaceutical manufacturing by using an integrated process with fewer steps and shorter processing times; reducing the equipment footprint; supporting an enhanced quality by design (QbD) development and use of process analytical technology (PAT) and models; enabling real-time product quality monitor ... ...