Continuous Manufacturing
Continuous Manufacturing (CM) offers many attractive properties for the pharmaceutical manufacturing industry such as enhanced consistency of production as well as the ability to dial up a design space point for experimental formulation or process design or to scale output of manufacture seemlessly. As solid oral dosage form CM becomes more common place in the pharmaceutical industry, PAT deployment in these processes has become an essential part of the control strategy and the basis of Real Time Release Testing (RTRT). As such, the speed and robustness of the PAT measurements are of paramount importance. Other considerations in ensuring the quality & robustness of in-line PAT measurements in a CM environment such as robustness of the measurement, stability of the instrument and consistency between instruments to facilitate calibration transfer. Sentronic offers unparalleled high performance in these areas. In addition, Sentronic’s fully validated SentroSuite software platform offers excellent compliance in data integrity and 21CFR11. Sentronic Analysers can be directly integrated into the PAT stack with Siemens SiPAT, Optimal SynTQ and Perceptive Engineering PharmMV for process control integration.