Girish Malhotra
EPCOT International, USA

Abstract

Batch and continuous manufacturing are two distinct ways of manufacturing products. In pharmaceuticals due to volume of API (active pharmaceutical ingredients) needed to produce formulated doses these processes take a special meaning. In recent years some batch processes are being labeled as continuous processes. However, there is no clear indication whether these continuous processes are for API production or their formulations. This has and can result in significant confusion. An attempt is made to differentiate and clarify the confusion between the two processes. Production volumes and time clearly define the type of process should be used. Financial justification is necessary for each type of process.

BATCH, CONTINUOUS OR “FAKE/FALSE” CONTINUOUS PROCESSES

Use of “Fake and/or False” in our vocabulary has become very pervasive since 2016. I thought it would be useful and helpful if we re-visit definitions of Batch and Continuous production processes and try to see do either of them fit in the realm of False or Fake “B or C” process. My observations are based on my education, experiences in chemistry and chemical engineering and the prevailing practices established more than 100 years ago. They are also based on actual process design and development, scale up of developed processes and management of manufacturing processes and operations in fine/specialty chemicals, coatings, resins that were produced using organic chemicals. Many of the products were produced by reacting chemicals and others were formulated by blending different chemicals.

In recent months certain pharmaceutical processes have been labeled as “continuous manufacturing” but no process information has been shared. However, based on public information about the products their viability of being operated as a continuous process is extremely doubtful. Additional detai ...