An article jointly authored by specialists from Malvern Instruments and a major pharmaceutical company has been released.
The article describes the implementation of a Malvern Insitec online particle-size analyser on an active pharmaceutical-ingredient milling operation at a commercial site.
The Insitec was used to transform a standalone 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 the solution also opens the route to semi-continuous operation and real-time release.
The Insitec laser diffraction particle-size analyser was designed for use in the process environment.
The article describes the change from batch milling with particle size measured offline, to the use of real-time, online 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.
