New Article Describes PAT for Automated Pharma Mill Control
28 January 2010; Malvern, UK: 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
About Malvern Instruments
Malvern Instruments provides a range of complementary materials characterization tools that deliver inter-related measurements reflecting the complexities of particulates and disperse systems, nanomaterials and macromolecules. Analytical instruments from Malvern are used in the characterization of a wide variety of materials, from industrial bulk powders to nanomaterials and delicate macromolecules. A broad portfolio of innovative technologies is combined with intelligent, user-friendly software. These systems deliver industrially relevant data enabling our customers to make the connection between micro (such as particle size) and macro (bulk) material properties (rheology) and chemical composition (chemical imaging).
Particle size, particle shape, zeta potential, molecular weight, chemical composition and rheological properties measurements are now joined by advanced chromatography solutions (GPC/SEC), extending Malvern's technologies for protein molecular weight, size and aggregation measurements, and synthetic polymer molecular weight and distribution. The company's laboratory, at-line, on-line and in-line solutions are proven in sectors as diverse as cement production and pharmaceutical drug discovery.
Headquartered in Malvern, UK, Malvern Instruments has subsidiary organizations in all major European markets, North America, China, Korea and Japan, a joint venture in India, a global distributor network and applications laboratories around the world. www.malvern.com
For press information, please contact:
Trish Appleton,
Kapler Communications
Knowledge Centre, Wyboston Lakes,
Great North Road, Wyboston,
Bedfordshire, MK44 3BY, UK
Tel: +44 (0)1480 479280;
Fax: +44 (0)1480 470343
trish@kapleronline.com
USA contact:
Marisa Fraser,
Malvern Instruments Inc.
117 Flanders Road, Westborough,
MA 01581-1042 USA
Tel: +1 508 768 6400
Fax: +1 508 768 6403
marisa.fraser@malvern.com
Please send sales enquiries to:
Alison Vines,
Malvern Instruments Ltd
Enigma Business Park, Grovewood Road,
Malvern, Worcestershire WR14 1XZ UK
Tel: +44 (0) 1684 892456;
Fax: +44 (0) 1684 892789
salesinfo@malvern.com
