Automatic Testing System with VisioNIR
Nowadays, batches easily reach sizes of >1,000,000 tablets. However, only 30 tablets are used for content uniformity (CU) release testing. But there can be many more… This same assay of samples is typically checked for other parameters such as weight, hardness, thickness and diameter.
These huge batch sizes and the trend for the change to continuous productionrequire rapid and accurate analysis methods such as the well-known parameter tester Universal Test System (UTS4.1/CM) from Kraemer Elektronik and the rapid NIR measurement device VisioNIR LS for CU from Visiotec. The UTS-Extended with integrated VisioNIR LS technology can check for these physical-chemicalcharacteristics. In some cases, the thickness or the bizarre shape of the tablets does not allow the transmission measurement.
The solution is the possibility to switch via a multiplexer from transmission to reflectionmode to enable the user to measure each available tablet on the market. For detailed homogeneity inspection requirements, the tablet can be area-scanned in reflection mode. The resulting plot is an image of the tablet showing the active pharmaceutical ingredient (API) content distribution in the tablet. On the other hand, the mean content of this multi-spot measurement can be used for an overall statement of the API content of the tablet.
From a quality point of view, the RAS (rapid area scan) measurement provides much more solid results.
As opposed to the required 30 samples, the UTS-Extended can increase the sampling size up to 240 samples per hour.
The system can be run at-line configuration for automated tablet feeding from a connected tablet press or as a standalone system in production or the laboratory.
The reliable trend monitoring visualizes the CU prediction value of each sampled tablet. Outliers can be safely identified. The UTS-Extended is dedicated to real time release (RTR).
- Multivariate evaluation
- Compact design
- Solid industrial construction
- Increasing sampling size due to rapid spectra acquisition
- Integrated PAT solution and sophisticated online configuration
- Qualitative and quantitative online analysis
- Rapid and robust diode array technology
- Fiber optics technology
- Retrofittable on UTS 4.1 / CM
- CFR 21 part 11 compliance