Regulatory demands for ‘in process’ performance data have changed the pharma sector’s approach to materials analysis and enhanced the quality of the drugs it produces according to Freeman Technology.
in-Pharmatechnologist.com spoke with company director of operations Tim Freeman at Interphex 2011 in New York, US, who explained that this change in mindset has had a significant impact on powder flow analysis.
Freeman said that initiatives like PAT and QbD are encouraging industry to consider a material’s characteristics in combination with its intended usage in the manufacturing process, rather than as a separate characteristic.
This change is driving the development of new analysis technologies, Freeman continued, adding that: “The advantage we have in the 21st century is that we can characterise materials… in process relevant ways.
“If you have powder in a silo or hopper, rather than just looking at how the density of the powder changes we can measure the sheer strength of the powder to try and simulate the environment the powder is stored in.”
He added that the ability to quantify powder performance allows drug makers to optimise both formulation development and scale up, improving efficiency and saving time and money.