The author reviews the draft guidance on process validation, its QbD applications, and its potential impact on sterile manufacturing operations. Individuals working in pharmaceutical sterile ...

The first article in this two-part series (OGJ, May 6, 2013, p. 94) presented four process safety examples of possible inadequate overpressure protection design in amine natural gas sweetening, glycol ...

A PQRI expert working group provides case study examples of risk-management applications. This case study on process design space is the first of eight in a series put together by the Product Quality ...

Process Engineering encompasses the analysis, modeling, simulation, optimization, design, control and operation of process systems, from micro-sized systems to huge industrial facilities. Many ...