Malvern's Insitec Particle Size Analyzers Support Big Pharma QbD
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11 December 2008: Malvern, UK: A recent review of activity within the pharmaceutical industry has shown that leading manufacturers are using Process Analytical Technology (PAT) tools such as the Insitec online particle size analyzer from Malvern Instruments, to implement Quality by Design (QbD).
"Knowledge-based product development, the concept that underpins QbD, requires effective data acquisition at an early stage," confirmed Alon Vaisman, Applications Development Manager Pharmaceuticals at Malvern Instruments. "The use of relevant PAT tools accelerates this information gathering process. With the Insitec real-time particle size analyzer, for example, milling parameters can be comprehensively scoped and optimized in a matter of hours, rather than days or even weeks."
As the symbiotic nature of PAT and QbD becomes clear, leading pharmaceutical producers are investing heavily in instrumentation at the pilot plant stage. Insitec offers a proven solution for the measurement of particle size, a critical variable in processes such as spray drying, compaction, emulsification and milling. Its use through scale-up, into production, is helping manufacturers transform operating practice in the way envisioned by the FDA.
The Insitec range of laser diffraction analyzers provides options for in- and on-line particle size measurement, for wet and dry processes with particles in the size range 0.1 to 1000 microns. Automated, integrated solutions for continuous measurement, these systems are fully cGMP/GAMP compliant. They provide complete particle size distribution measurement every 0.25 seconds allowing even the most rapidly changing process to be effectively monitored and controlled. www.malvern.com
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 the latest 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 distribution, particle shape information, zeta potential, molecular weight, chemical composition, and bulk materials properties can all be determined with instruments from the Malvern range. 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
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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
