A newly published article, jointly authored by specialists from Malvern Instruments and a major pharmaceutical company, describes the implementation of a Malvern Insitec on-line particle size analyzer on an active pharmaceutical ingredient milling operation at a commercial site. The Insitec was used to transform a stand-alone manual mill into an automated process unit that will integrate into the manufacturing facility. Automation benefits include improved product quality, increased throughput, and less waste, and the authors state that this proven solution also opens the route to semi-continuous operation and real-time release, both of which are important long-term goals for operational excellence.

Unlike some process analytical technology (PAT) instruments that are modifications of laboratory solutions, the Insitec laser diffraction particle size analyzer was designed specifically for use in the process environment and is proving valuable for milling operations such as this.

The article describes the change from batch milling with particle size measured off-line, to the use of real-time, on-line measurement and control, and the efficiencies and benefits that this has delivered. The change began with a pilot-plant trial of the Insitec, followed by implementation at the commercial manufacturing site and the successful development of closed-loop control of the mill. With automated control in place the mill responds flexibly to batch to batch variation in the feed, consistently maintaining product quality.

Read the full case study online at www.malvern.com/PATsolutionforautomillcontrol