The time has come to dispatch batch processing; welcome to pharma's continuous-processing era. That appears to be the consensus from last week's Interphex trade show.
Use of process analytical technology, a regulatory framework for measuring and controlling process parameters, can go a long way toward helping drugmakers through the transition, says FDA compliance officer Francis Godwin, according to in-Pharmatechnologist.
PAT's provisions for defect detection, fouling and cleaning requirements are all enablers of continuous processing. Likewise with Quality by Design techniques and new FDA guidance on process validation.
Speed and production efficiency are two advantages of continuous over batch processing. Additional advantages are the need for less material in experimental runs and a reduction in the amount of time products are dormant on the factory floor.
However, some fundamental details remain to be worked out. These details include how the FDA will define a batch versus a lot; how recalls may be handled; and how to clean a continuous manufacturing system with regard to startup and shutdown time, as PharmTech Talk notes.