A major pharmaceutical company was mandated to implement PAT (Process Automation Technology) for the purpose of real-time API release. The CPS solution provided three significant benefits.
Previously, the system would cease blending after a predetermined number of rotations, resulting in the product being set aside in inventory until the QC laboratory conducted solvent-based tests to verify its quality. Out-of-specification products were returned to the blender for additional blending and retesting. The PAT solution offered the following advantages:
- Reduced Capital and Inventory: By reducing inventory during the waiting period for QC test results, the solution minimized capital and inventory expenses.
- Cost Savings in Product Testing: The solution reduced labor and solvent hazardous waste disposal costs, leading to cost savings in product testing.
- Accelerated Production Times: The PAT solution enabled shorter production times by optimizing the blending process.
The CPS PAT process solution utilized standard, off-the-shelf software products that provided the client with the flexibility to modify chemometric and endpoint determination calculations. The use of OPC communications drivers enabled the integration of any test instrument into the system.
Key features of the CPS PAT solution include:
- Wireless Connection of the NIR Sensor: The NIR sensor, which rotates with the blender, facilitates continuous monitoring of the product’s quality.
- Third-Party Off-the-Shelf Software: The solution employs third-party software products, rather than traditional proprietary software, to enhance flexibility and cost-effectiveness.
- Compatibility with Any OPC-Compliant Instrument: The solution supports a wide range of OPC-compliant instruments, including FTIR, NIR, chromatographs, and spectrometers.
