Continuous Manufacturing

What is Continuous Manufacturing?

The term ‘continuous manufacturing’ —
(A) means a process where the input materials are continuously fed into and transformed within the process, and the processed output materials are continuously removed from the system; and,
(B) consists of an integrated process that consists of a series of two or more unit operations.

115TH CONGRESS 2D SESSION H. R. 5568 [Link to PDF]

The Case for Continuous Manufacturing

Continuous manufacturing has been shown to greatly reduce the time and cost of developing new medicines while enabling significant improvements in quality and reliability.

Continuous manufacturing is supported by the US Food and Drug Administration (FDA), the Unites States Pharmacopeia, Health Canada, the European Medicines Agency, the Chinese Food and Drug Administration, and the Japanese Pharmaceuticals and Medical Devices Agency.

Benefits of Continuous Manufacturing

  • Better Quality

    Resistant to segregation. Steady process in defined state of control

  • More Flexible

    Flexible lot sizes enable the manufacture of as much product as needed to meet demand. Smaller footprint.

  • Less Expensive

    Reduced labor requirements, less expensive manufacturing.

  • Controllable

    Combining PAT and closed-loop automated process control enables processes to be monitored and controlled continuously.

  • No Scale Up

    Continuous processes are scaled up simply by running them for longer periods. The same size equipment is used to develop the process and to operate it.

  • Faster Development

    Extensive (30-point) DoE experiments in a single day, saving money, time and raw materials.