German-based company OYSTAR Huettlin has enhanced its fluidised-bed process with two different sensor technologies.
Its now uses near-infrared spectroscopy and fibre-optic spatial frequency filtration for particle size determination. They monitor various process parameters that are important for producing pharmaceuticals. Both of these inline measurement processes comply with the Process Analytical Technology requirements of the US Food and Drug Administration (FDA).
The goal of the PAT initiative is to identify, describe and ultimately control all process-critical variables in connection with producing pharmaceuticals. This will serve to steadily improve quality and safety while reducing manufacturing costs.
Near-infrared technology is used to monitor product moisture, an important process parameter when making solid medications. It continually measures raw materials and intermediate products to provide a constant picture of ongoing processes. Initial, process and final checks make it possible to quickly detect and correct production errors, downtimes and defective products. In this case, an industrial spectrometer from NIR-Online in Walldorf, Germany is employed. It is claimed to be the world's first precalibrated optical system for measuring product moisture in the fluidized bed.
A measurement device used by OYSTAR Huettlin also uses an inline sensor to capture both particle sizes and distribution. During coating, it also monitors grain growth. OYSTAR Huettlin is also already using this fiber-optic spatial frequency filtration technology for quality control.
The two PAT-relevant sensors are deployable in OYSTAR Huettlin machines for batches of 1.5 kg and larger and are already installed at customer facilities.