Using the in-processing control with near infrared spectroscopy (NIR), the active ingredient content of each tablet is determined directly. Many time-consuming and expensive investigations in the laboratory are dispensed with.
Using two different measuring methods the exact active ingredient content can be determined through NIR (near-infrared spectroscopy): With internal NIR measurement the precise active ingredient content is determined by means of the reflection process, directly following the compression of the granulate, all while still inside the press. This is where Fette Compacting's VisioNIR is employed. With external NIR, a sampling takes place first. This active ingredient analysis takes place on the NIR Checkmaster.
The two options in detail:
1. NIR Checkmaster
The online measurement of the API (active pharmaceutical ingredients) by the NIR Checkmaster sets new standards. The washable equipment combines the physical tablet analysis (weight, thickness, diameter and hardness) with the automatic active ingredient analysis.
The arrangement of the NIR measurement and measuring of weight takes place for each analyzed tablet. With this, the NIR Checkmaster achieves extremely short measuring times and provides a complete picture of the chemical and physical characteristics. The number of specimen tablets per measurement process and the frequency of the sampling are set flexibly.
The batch can be approved in a short time (thanks also to the improved documentation). And: The software employed intervenes actively in the compression process if predetermined tolerances are not observed.
The VisioNIR is an in-line near-infrared spectrometer which determines the active ingredient content of the pharmaceutical product directly in the tablet press. The analysis through reflection offers a non-destructive, 100 percent control of the chemical composition, hardness, moisture and homogeneity—and that within a few milliseconds.
The VisioNIR is installed within the tablet press. Currently, operation and assessment still takes place via the operating terminal provided. In future, however, the compaction terminal will be employed for this. For statistical purposes according to the GMP Directives, all analysis data per batch can be saved.