Based on the Quality by Design principles, RCPE develops concepts to guarantee quality of drug products. This includes In-process controls and Real Time Release concepts. Selection and adaption of appropriate process monitoring technologies exactly for the specific process needs is one field of operations as well as proper and timely aligned data acquisition, treatment and evaluation to be used for process control actions. RCPEs process analytical methods include established methods as well as development of novel technologies such as Optical Coherence Tomography for application in pharmaceutical industry. Process risk evaluation and profound process understanding is applied to establish controlled process conditions.

In-line monitoring of coating processes

  • Real-time acquisition of process data via Optical Coherence Tomography (OCT)
  • Coating thickness and coating quality based on a statistical representative amount of data
  • Direct measurement of physical length – no calibration model needed
  • Implementation in all state-of-the-art coating processes
  • GMP, CE and ATEX compliant sensor
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100% Quality Inspection of Tablets

  • In-line control of API content of final tablets
  • High number of tablets (> 500.000/hour) with high resolution
  • Intra and inter tablet content uniformity
  • Mapping of single dosage forms
  • Strategies for real-time calculation of process information and reduction of huge data amount
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