Developments and Challenges: Adapting Continuous Manufacturing for Pharmaceuticals


With help from FDA, continuous manufacturing is gaining traction in pharmaceutical manufacturing.

By Gautam Chauhan, M.S., and Vivek Gupta, Ph.D., both at St. John’s University

For more than a century, little has changed in the way pharmaceuticals have been manufactured. Traditionally, dosage forms are put together by a systematic step-by-step assembly of various components, known as batch manufacturing. Even after significant advances in the technology, the underlying process has not really changed, and drawbacks remain, such as waste of material and time. In a batch process, one manufacturing step must be completed before moving on to the next step; and similarly, one batch must be finished before starting another.1 Batch manufacturing is a lengthy process comprising multiple steps that require a quality check/test after each, and thus poses a serious risk of human error and product contamination. In addition, because batch processing requires multiple pieces of complicated equipment and machinery, the raw material and intermediates may need to be stored and moved from one site to another to complete the manufacturing process.2

Deficiencies in current unit operations result in significant revenue loss to the pharmaceutical industry due to drug recalls, wasted man hours, contamination, and product loss.3 Continuous manufacturing (CM) presents a feasible solution to these issues by providing a resource to facilitate production of the final dosage form in a single nonstop process with no equipment downtime. In CM, the material moves nonstop within the same facility, eliminating any hold time between steps. Because a small number of people are involved in CM, the risk of human error is significantly reduced. The operating cost is also reduced as less product handling is required during the process. Additionally, the Food and Drug Administration (FDA) estimates that some drugs that take three to four weeks to produce in a conventional batch method can be produced in a day with CM. Also, when it comes to day-to-day expenditures like water and electricity, CM, being a closed-circuit method, requires lower utility expenditures. With no holds and less human error, the continuous method is more reliable and safer.4

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April 2019

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