The PAT initiative encourages the pharmaceutical industry to embrace new analytical approaches with the aim of transforming
process development and manufacture. Realtime process monitoring and automated control are essential elements of this transformation,
which has the potential to improve product quality, cut production costs and reduce time to market.
This case study highlights the availability, relevance, and benefits of a commercially available PAT solution for particle-size
analysis. For pharmaceutical products, particle size is often a critical quality attribute that directly impacts performance
and/or manufacturability, so better control delivers significant gains. An on-line system was used to transform a stand-alone
manual mill into an automated process unit that will integrate into a manufacturing facility with a distributed control system
or statistical process control. The Insitec analyzer used is a proven process solution for real-time particle sizing that
additionally meets pharmaceutical industry requirements for clean in place, sterilize in place, validation and 21 CFR Part 11, the federal regulations providing guidelines on electronic records and electronic signatures in the United States.
The benefits of automating control include improved product quality, increased throughput, and less waste. Furthermore, automation
opens up a route to semicontinuous operation and real-time release, important long-term goals in reaching operational excellence.
Qualification of an automated mill with closed-loop control delivers a solution that could potentially be used elsewhere in
the company for both pilot- and full-scale operations. Semicontinuous operation with extended run times is a realistic and
attractive alternative to conventional batch operations.
Alon Vaisman* is an application development manager at Malvern Instruments, Enigma Business Park, Grovewood Road, Malvern, Worcestershire,
WR14 1XZ, UK, tel: +44 (0)1684 892456, fax +44 (0)1684 892789 email@example.com
. Yanhui Hu is a principal quality-by-design engineer in the quality assurance division at Abbott Laboratories.
*To whom all correspondence should be addressed.