The pharmaceutical solid dose manufacturing process is increasingly fast-moving and competitive field. Trending towards continuous manufacturing, counterfeiting and low dose active pharmaceutical ingredient (API) products result in increasing demands on the product quality and require accurate and rapid inspection technologies. Our Quality Control solutions by Pharma Technology provide 100% inspection of each individual product and enables Quality by Design (QbD) and Final Quality Inspection (FQI) solutions.
The aspect of Quality and Production
The increasing demand of sampling in continuous manufacturing raises the costs and analytical effort in the lab to release the product. Measuring each individual tablet in terms of mass and API fraction enables the knowledge of the Content Uniformity (CU) and supports the Real Time Decision (RTD). Even Out of Specification (OOS) trends – caused by upstream process steps – can be identified and looped back avoiding non-conforming production. If errors were identified too late, Q-Control can be used as Batch Savers removing all non-conforming product from the batch.
The aspect of Cost
One major goal of each pharmaceutical company is to optimize their production process in terms of efficiency, costs and consistency. By use of Q-Control technology, the cost-intensive analytical effort in the lab can be minimized. Fast and easy data acquisition off-board the production line in the Design of Experiment (DoE) provides a rapid image of the influences of Critical Process Parameters (CPP) on the Critical Quality Attributes (CQA) and helps to identify the Design Space (DS).
The aspect of Compliance
Inspectors regularly check in detail that the inspection tools used has been verified and that all corresponding data have been stored accordingly. Further data requirements include integrity, traceability and counterfeiting. Q-Control machines ensure the highest standards of data protection. USP and EMA NIR verification tests, such as wavelength accuracy and repeatability, photometric noise and high/low flux are included in the software. In addition to microwave resonator calibration, additional product sampling is applied to determine the mass using a highly accurate laboratory scale and to maintain the calibration regression. For the laser scanner, special test bodies can be inserted into the machine to ensure accurate thickness and diameter/length measurement.
Our Solutions
The CUB-X is an innovative and versatile tablet inspection system, which can be used for OSD product & process development, as well as for IPC sample analysis and full batch inspection & sorting.
The CU-120 analyses individual dosage from each single tablet up to a speed of 120.000 tablets per hour. The data can be used to control an upstream process application, e. g. a tablet press, continuous mixer in a QbD (Quality by Design) approach and all non-compliant products will be rejected.
The CW-150 measures the individual weight of every single tablet or capsule up to a speed of 150.000 objects per hour and rejects all non-compliant products. The ideal tool for in-line Quality Inspection and RTD (Real Time Decision).
