UTS-NIR ? Tablet testing system with API content measurement


The UTS-NIR is an advanced automatic tablet testing system that integrates traditional physical parameter measurements with near-infrared spectroscopy (NIR) to assess the active pharmaceutical ingredient (API) content in tablets. This dual-functionality enables comprehensive quality control by evaluating both the physical attributes and chemical composition of tablets.

Key Features:

  • Comprehensive Testing Capabilities: The UTS-NIR measures weight, thickness, diameter (or length), and hardness of tablets, ensuring adherence to stringent quality standards.

  • Near-Infrared Spectroscopy Integration: By incorporating NIR analysis, the system accurately determines the API content within each tablet, facilitating real-time monitoring of dosage uniformity and potency.

  • Process Analytical Technology (PAT) Compliance: Serving as a fully automated online PAT tool, the UTS-NIR can be utilized both in production environments and as an offline tester in laboratories. When integrated with a tablet press, it enables continuous process monitoring and immediate transmission of test results, allowing for prompt corrective actions if deviations occur.

  • Seamless Application Transfer: The system employs the NIRFlex N-500 FT-NIR transmission spectrometer from Büchi Labortechnik AG, ensuring reliable transfer of analytical applications from laboratory settings to production environments.

  • Precise Tablet Positioning: A patented two-jaw centering mechanism positions each tablet with an accuracy of ±0.1 mm, guaranteeing precise and reproducible measurement results.

  • Compact and Modular Design: The space-saving construction allows the UTS-NIR to fit under tablet chutes from various press manufacturers. Additionally, it offers modularity to accommodate different sample collectors based on specific laboratory analysis requirements.

  • Regulatory Compliance: The system conforms to both European and US Pharmacopoeia standards and is compliant with 21 CFR Part 11 regulations, ensuring data integrity and security.

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The UTS NIR automatic tablet testing system combines the measurement of the physical parameters weight, thickness, diameter, length and hardness with near-infrared spectroscopy (FT-NIR analysis) to determine a tablet’s active ingredient content.

PAT

The UTS NIR is therefore a fully automated online PAT tool, which can be used in production or as an offline tester in the laboratory. In conjunction with a tablet press, the system allows you to monitor the production process continuously and transmit all test results directly to the tablet press. This way, you can take action straight away if there’s a problem, keeping your production process safe.

In addition, the NIRFlex N-500 FT-NIR transmission spectrometer from Büchi Labortechnik AG enables applications to be reliably transferred from the lab tester to the UTS NIR.

The system conforms to the European and US Pharmacopoeia and is 21 CFR Part 11 compliant.

Tablet positioning

The precise, patented two-jaw centering mechanism positions the test specimen with an accuracy of ± 0.1mm, guaranteeing very precise measurement results that are standard in the laboratory sector.

Compact & modular

Its compact, space-saving design and low height mean the UTS NIR fits under all tablet chutes from the most popular tablet press manufacturers. Depending on customer requirements, various sample collectors are available, permitting further analysis in the laboratory.

Removal of all parts requiring cleaning is uncomplicated and very fast, with no need for tools.

 

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