Insitec particle size analyzers allow milling processes to meet specifications
Pharmaceutical Industry Solutions

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Implementation of an on-line particle size analyzer -

Active pharmaceutical ingredient milling operation at a commercial site

A PAT solution for automated mill control

A leading pharmaceutical company has implemented automated mill control at a commercial site using an on-line Insitec analyzer, a PAT solution for real-time particle size measurement. The mill is used to produce active pharmaceutical ingredient particles of closely defined size and distribution. The project has transformed a standalone manual mill into an automated unit that will integrate into a manufacturing facility with either a distributed control system or statistical process control. Mill speed is now automatically varied in response to continuous particle size data. Control is highly effective even without extensive loop tuning. Major gains include:

• The development of a robust solution that can be used for all subsequent pilot and full-scale milling operations.
• Improved product quality: a more consistent and tightly defined particle size distribution
• Less waste
• Higher throughput

The developed unit responds to upstream fluctuations impacting the feed, maintaining the product specification at all times. Each new batch can be confidently processed with minimal testing. Semi-continuous operation with extended run times is now a realistic and attractive option.

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