Kirjeldus
- Delivers data about physical tablet proper-ties (weight, thickness, diameter, hardness)
- Content uniformity analysis; simultaneous quantification of multiple components, such as API(s) and moisture content
- Full validation with IQ/OQ/PQ documentation and USP/EP protocols
The regulatory authorities require the accurate analysis of finished pharmaceutical goods to confirm the products’ content uniformity and physical characteristics.
Traditionally, content uniformity analysis has been performed off-line by liquid chromatography. This time-consuming and operator-intensive process requires a manual collection of sample tablets at regular intervals during a batch and a consecutive laboratory analysis. Near-infrared transmission spectroscopy has proven to be a reliable, rapid and non-destructive alternative for routine tablet content uniformity testing along with moisture and excipient analysis.
The TANDEM is the leading technology available on the market for FDA-approved real-time release (RTR).
Hassle-free maintenance
TANDEM is designed to be easily maintained by the user, e.g. exchange of NIR light source or tablet holders on product change. Permanent online diagnostics monitor the instrument and advise the user of a failing component. Instrument performance is validated at a click of a button using Bruker’s Instrument Test Software in conjunction with the built-in Internal Validation Unit, assuring proper operation of the entire system. The instrument can be serviced quickly and will be back in operation with a minimal disruption of the manufacturing process.
