ERNIE HILLIER
Member of Chimica Oggi / Chemistry Today Scientific Advisory Board

The FDA initiative from 2004 whose focus on QbD, PAT, to get to the implementation of Continuous Manufacturing is becoming more and more a reality. At the core of this activity is the collaboration and teamwork between process development, QC, and manufacturing which is essential for companywide implementation and success.

Process development teams are investigating the latest technologies which enables them to have a more thorough understanding of their process. With an increase in process knowledge comes understanding that can lead to better process control prior to transfer to manufacturing. While the process teams are incorporating the latest technologies, they must also integrate both hardware and software to enable continuous manufacturing. Another critical piece is the new expanded role for quality control supporting both the process control and manufacturing teams at the appropriate times to transfer knowledge and rationale for moving a product into a new continuous manufacturing paradigm.

As we link flow chemistry as a key enabling tool for continuous manufacturing there are two significant benefits to the business: 1. Faste ...