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The Challenge
To build a system that completely qualifies a Dry Powder Inhaler (DPI) Product based on its ability and efficacy to aerolize and deliver targeted drugs to a patient's lungs.
The Solution
Integrating an NI CompactRIO (cRIO) controller with FPGA and real-time determinism to instantaneously detect events based on signal signatures along with NI Compact Vision System (CVS) to evaluate the correctness of the build and assembly provided a holistic solution to detecting defective DPI before use by patients.
The System
The end solution is an End-of-Line (EOL) Automated Test Equipment (ATE), deployed on the production floor for qualifying each part that was manufactured. This consists of two parallel & asynchronous test fixtures for measuring the flow v/s pressure characteristics of the DPI, as well as, an addon machine for vision inspection.
As the system is built for the pharmaceutical industry, it has to conform to the electronic standards for Medical Equipment, namely the US FDA prescribed 21 CFR Part 11 standard. This Includes the implementation of controls such as access controls, audit trials and auditing functions, system validation, electronic signatures, data retention and permanence, and reasonable tamper proofing.
