Control charts have two general uses in an improvement project. Undeniably, the most common application is as a tool to ...

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 ...

Control charts have been widely used for monitoring production processes and identifying assignable causes of variability. Many papers investigate the application of control charts in different ...

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 ...

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 ...