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 analyser 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, Malvern's applications development manager pharmaceuticals. "The use of relevant PAT tools accelerates this information gathering process. With the Insitec real-time particle size analyser, for example, milling parameters can be comprehensively scoped and optimised in a matter of hours, rather than days or even weeks."