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CU-120 100% CONTENT UNIFORMITY

CU-120 100% CONTENT UNIFORMITY

CU-120 100% CONTENT UNIFORMITY

Product catalog summary
Overview
The document introduces the CU-120, an innovative in-line solution designed to ensure the quality of individual tablets by combining two main control methods: API’s fraction and weight. It is capable of analyzing up to 120,000 tablets per hour, ensuring content uniformity and enabling real-time decision-making (RTD) by rejecting non-compliant products.

Specifications
  • Maximum throughput: 120,000 tablets per hour
  • Product width: 6 mm to 24 mm
  • Product height: up to 9 mm
  • Weighing range: 20 mg to 2000 mg
  • Weight measurement accuracy: +/- 1 mg (3 Sigma)
  • Noise level: ≤70 dB (A)
  • Power supply: 380V 3ph + N + PE
  • Frequency: 50 Hz / 60 Hz
  • Polymer contact parts: FDA approved

Control Methods
  • NIR-SRS Technology: Utilizes near-infrared spatially resolved spectroscopy for predicting API fractions.
  • 3D Microwave Resonator: Measures individual tablet weight with high precision.

Features
  • 100% content uniformity testing
  • Thickness and diameter/length measurement by laser scanner
  • Advanced hardness measurement
  • Quality by Design (QbD) approach
  • Real-time decision-making capabilities
  • Batch recovery and counterfeit detection

Design and Compliance
The CU-120 is designed for ease of use in production environments, with fast changeover capabilities and compliance with European Union’s CE Guidelines. It includes a manual, safety instructions, and wiring diagram. The company offers installation assistance and chemometric model development support.

Technical Data
  • Integrated air extraction with Hepa filter H13
  • Compressed air requirement: 500L/min - min. 6 bar
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Catalog excerpts

CU-120 100% CONTENT UNIFORMITY-1

New and innovative in-line solution designed to ensure the quality of each individual tablet, by combining two main control methods: API’s fraction and weight. The CU-120 analyses individual dosage from each single tablet up to a speed of 120.000 tablets per hour. The data can be used to control an upstream process application, e. g. a tablet press, continuous mixer in a QbD (Quality by Design) approach and all non-compliant products will be rejected. The ideal tool for Content Uniformity Inspection and RTD (Real Time Decision).

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CU-120 100% CONTENT UNIFORMITY-2

Each product is inspected by the multipoint NIR-SRS "near-Infrared spatially resolved technology” probe to predict APIs fraction, and a 3D microwave resonator allowing to measure individual weight. Various extensive repeatability tests campaigns and industrial case studies have shown that the predictions are within the required error boundaries. The unit include an encapsulated weighcell or a highly accurate 4-P tester (measuring weight, thickness, hardness, and diameter), for automatic calibration of the weight measurement instrument. A linear regression is performed to warranty that the accuracy...

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CU-120 100% CONTENT UNIFORMITY-3

NIR SRS TECHNOLOGY SPATIALLY RESOLVED SPECTROSCOPY FOR API’S FRACTION PREDICTION Equipped with the fastest NIR-SRS technology and an highly precise 3-D microwave weight measurement station this equipment is dedicated to provide you a very accurate Content Uniformity prediction, and to remove 100% of non-compliant products from good products, allowing RTD (Real Time Decision) The machine can also be used for R&D developments, batch recovery/saving, mix-up and counterfeit products. The unit has been developed with an utmost care to the mechanical design allowing fast changeover and affordable format...

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CU-120 100% CONTENT UNIFORMITY-4

Technical data : PHARMA Rue Graham Bell 8 B-1402 Thines (Nivelles) - Belgium Phone : +32 (0)67 70 13 00 E-Mail : [email protected]

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.