TANDEM On-line Tablet Characterization PAT Tool
TANDEM is an integrated, automated, on-line pharmaceutical tablet characterization tool providing tablet weight, thickness, hardness and NIR content uniformity analysis.
- Provides tablet weight, thickness, hardness and NIR content
- uniformity analysis
- Measure over 300 tablets per batch instead of 10 by HPLC
- Stratified sampling as recommended by PQRI
- Full validation with IQ/OQ/PQ documentation and USP/EP protocols
- Can be connected to any tablet press
The pharmaceutical regulatory authorities require accurate analysis of finished pharmaceutical products, such as tablets and capsules, to confirm that they contain the required amount of the active ingredient. This quantitative analysis of product potency is referred to as content uniformity.
Traditionally content uniformity analysis has been performed by HPLC. This high volume, time-consuming, labor-intensive process requires that test samples be taken from the production area to the QC/QA laboratory where they are prepared and analyzed. Pharmaceutical companies are striving to implement new process analytical technologies that can help improve product quality and to reduce manufacturing costs. Near-infrared spectroscopy has proven to be rapid, cost and time-effective, convenient, non-destructive, alternative for routine content uniformity analysis.
TANDEM provides a comprehensive solutions for the pharmaceutical industry. It provides a full set of tablet characterization parameters including weight, size, thickness, hardness, diameter and NIR content uniformity in a single analyzer. The system consists of a Bruker MATRIX™ near infrared spectrometer, a Dr. Schleuniger 10X-T tablet testing system, and a tablet handling unit. TANDEM can be integrated with existing tablet pressing systems for automated analysis. Additionally, the analysis information can be used immediately to adjust production parameters to improve product uniformity. Methods can be developed on the TANDEM or they can be transferred from a Bruker MPA FT-NIR spectrometer.
Technologies used are protected by one or more of the following patents: US 5309217; DE 4212143; US 7034944; US 5923422; DE 19704598
