Batch, Continuous or 'Fake/False' Continuous Processes in Pharmaceutical Manufacturing

摘要

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.