Continuous processing in the pharmaceutical industry - Changing the mind set

The pharmaceutical industry is a highly regulated industry and all production must be carried out in accordance with good manufacturing practice. Traditionally, virtually all manufacturing operations have been carried out batch wise in spite of cost disadvantages and the fact that in many cases continuous processing could lead to the manufacture of purer products. The regulatory environment tends to stifle any attempts to change the process once the development stage is over and the product and process have been licensed. This has created a mind set amongst the industry's professionals that batch processes are the only acceptable way forward. However; the regulatory authorities, particularly the Food and Drug Administration in America, have recognized that continuous processing has the potential to improve product quality and are encouraging the industry to reconsider their ideas. This paper examines how chemical engineers can use the opportunity that arises from this changed regulatory environment to revisit their own ideas and drive a change of mind set within the industry.