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Production and Release in the 21st Century: Prizing the Fingers of cGMP from Respimat's Testing Robots in Early Development

Wachtel H, Richter F.

Respiratory Drug Delivery 2014. Volume 1, 2014: 277-286.

Abstract:

Current device development requires an unprecedented precision with respect to the final product quality. Bearing in mind that an automated quality check of all devices (100%) is the standard for all leading manufacturers, it is obvious that also in early development robotic testing is advancing. Of course, handling studies and in vitro investigations according to pharmacopeial procedures are carried out but there are considerable advantages when testing new devices by a robotic system. Comparing fully automated handling by a robotic system with manually performed bench tests, the robot has longer working hours, higher performance speed, better reproducibility and permits the integration and application of multiple sensor systems. However, the complexity of current robotic systems requires considerable investment. While technically good robotic systems outperform manual testing, enabling full cGMP status for such systems can make them impractical in early development. However, once experience has been gained in the performance of sub-components of a proposed robotic system, modules may be transferred to production for implementation in the framework of process analytical technology (PAT).