Aim: To demonstrate the potential of in-line nanoparticle size measurements using the NanoFlowSizer (NFS) as a PAT method. To achieve real-time process control by establishing automated regulation of ...

The extent to which products meet specifications needs to be systematically monitored in a production process. Product quality will typically be defined by two quantities: deviations from stated ...

ANSI/ISA-106.00.01, Procedure Automation for Continuous Process Operations, has been published by ISA. The standard sets forth mod­els, styles, strategies, philosophies, and life cycle for the ...

Anything that you do well is worth doing better over time. The term "continuous improvement" describes a process practiced by quality engineers but it speaks to something that every conscientious ...

In biopharmaceutical manufacturing, consistency is vital but hard to achieve. Turning raw materials into safe, high-quality medicines requires stable processes. However, the living cellular expression ...

Continuous manufacturing and a quality-by-design development approach are a natural fit. FDA, as well as other regulatory agencies around the world, have for many years been encouraging drug makers to ...