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. For more information, visit www.malvern.com.