Measurement of overall tablet product quality (Quality indicator) during bulk inspection and sorting process

PAT stands for Process Analytical Technology – new innovative technology initiated and promoted by the FDA, following on after computerization applications. Intelligent tools are to be applied to improve quality control, reduce the number of end product tests as well as increase productivity.

Bulk material is often inspected by optical means for cosmetic defects right after they are produced. The additional use of NIR technology in this step also assures the manufacturer of the correct chemical composition of the product. In combination one can be sure that a pharmaceutical product not only looks good but also is good ‘inside’ from the content point of view. The application is typically performed in real-time and to 100% before the bulk material is put into storage drums for further packaging processes.

Proditec and Visiotec have demonstrated the perfect integration of the Inspectab 100, Proditec tablet Inspection machine and the VisioNIR, the online NIR sensor.

VisioNIR is a technology that is revolutionary in meeting the pharmaceutical companies’ safety requirements. VisioNIR is capable of identifying tablets, capsules and gels with organic compounds without contact and ensuring that all products in one blister have the correct active substances, the correct concentrations of active substances together with the desired position in the blister. As VisioNIR-liquid it can also be used for liquids in ampoules, syringes, vials, etc.

The “Visio” part of the name stands for the optical checking, namely the presence, shape, color, size, chips and position of a product. NIR stands for Near Infra-Red spectroscopy of between 800 and 2,500 nm. Light with this wavelength stimulates molecular vibrations from which it is possible to determine the physical-chemical parameters and therefore the fingerprint of a mixture of substances. Mix-ups, changes and human errors can be ruled out once a check has been completed using VisioNIR.

VisioTec is an exclusive centre of competences of Uhlmann, the worldwide market leader in thermoformers and packaging lines for the manufacture of pharmaceuticals.

Examples for potential areas of implementation of NIR technology