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UTS Extended with visioNIR by Kraemer & Ischi Tablet testing equipment for checking Hardness, Diameter, Thickness, Weight and active pharmaceutical ingredient (API)

Testing T Systems for In-Process Control By Kraemer & Ischi STANDARD DEVICE UTS EXTENDEDD Automatic testing system with VisioNIR MEASURED PARAMETERS WEIGHT Nowadays, batches easily reach sizes of 1,000,000
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Testing T Systems for In-Process Control By Kraemer & Ischi STANDARD DEVICE UTS EXTENDEDD Automatic testing system with VisioNIR MEASURED PARAMETERS WEIGHT Nowadays, batches easily reach sizes of 1,000,000 tablets. However, only 30 tablets are used for content uniformity (CU) release testing. This same assay of samples is typically checked for other parameters such as weight, hardness, thickness and diameter. These huge batch sizes and the trend for the change to continuous production requiree rapid and accu- Test System (UTS) from Kraemer Elektronik and the rapid NIR measure- ment device VisioNIR LS for CU from Visiotec. The UTS-Extended with integrated VisioNIR LS technology can check for rate analysis methods such as the well-known parameter tester Universal these physical-chemical characteristics. In some cases, the thickness or the bizarre shape of the tablets does not allow the transmission measurement. The solution s is thee possibility to switch via a multiplexer from transmission to t reflection mode to enablee the user to measuree each available tablet on the market. Forr detailed homo- geneity inspection requirements, the tablet can be area-scanned in reflec- pharmaceutical ingredient (API) content distribution in thee tablet. On the other hand, the mean contentt of this multi-spot measurement can be used for an overall statement of the API content of the tablet. From a quality point of view, the RAS measurement provides more solidd results. tion mode. The resulting plot is an image off the tablet showing the active As opposed to the required 30 samples, the UTS-Extended can increase the sampling size up to 240 samples per hour. The system can be run at- press or as a standalone system in production or the laboratory. The relia- ble trend monitoring visualizes the CU prediction value of each sampled tablet. Outliers can be safely identified. The UTS-Extended is dedicated to line configuration for automated tablet feeding from a connected tablett real time releasee (RTR). THICKNESS LENGTH HARDNESS CONTENT UNIFORMITY ADVANTAGES Solid industrial construction Sophisticated at-lline configuration Rapid and robustt diode array technology Compact design Fiber optics technology Easy to retrofit CFR 21 part 11 compliance Integrated solution Increasing samplling size due to rapid spectra acquisition Multivariate evaluation CU inspection MEASUREMENT TECHNOLOGY REFLECTION TRANSMISSIONN Pic.: UTS Extended Testing Systems for In-Process Control UTS EXTENDED TECHNICAL DATA UTS EXTENDED Hardness Measurement principle Measurement method Measuring range Measurement accuracy Units of measure Tablet diameter Calibration Diameter / Length Drive Units of measure Measuring range Measurement accuracy Resolution Scale Model Weighing range Weighing accuracy Resolution Thickness Drive Measurement principle Units of measure Measuring range Measurement accuracy NIR Model Measurement principle Spectra Resolution Technology Number of scans Lamp Detector Weight Weight Power requirements Main voltage Load measurement cell (LMZ) with strain s gauge (DMS) Constant speed Hardness, diameter and thickness measurement 4 400N Standard, optional 4 40N / 8 800N 4 40N (+/- 0.1N),4 400N (+/- 1N), 8 800N (+/- 2N) N / Kp / SC 3 18mm (3 30mm manual) m Static, optional dynamic Stepper motor mm / Inch 3 18mm (3 30mm manual) m +/- 0.05mm 0.01mm Sartorius 0.01g 50g +/- 1mg stable environment, +/- 2mg unstable environment 0.1mg Stepper motor Linear Potentiometer mm / Inch 0 17mm +/- 0.05mm Visiotec Transmission or reflection nm or nm 3.9nm 3 numerical (100nm / 256 Diodes); 7.9 optical ( nm; 6.4 ( nm) Diode array technology 50 per sec Wolfram halogen, up to 1000h InGaAs 100kg Basic device VAC, 50 / 606 Hz The devices comply with EG-Maschinenrichtlinien 2006/42/EG andd EMV 2004/108/EG. Future technical changes reserved. Stand: Charles Ischi AG Langfeldstrasse 26 / 4528 Zuchwil / Switzerland Tel /
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