It is a real-time monitoring system for mixing uniformity and API/excipient content using NIR, designed to be attached and used on rotating containers in the pharmaceutical mixing process.
The SentroPAT BU, manufactured and sold by Sentronic based in Dresden, Germany, is a near-infrared spectrometer specifically designed for pharmaceutical mixing processes. It operates the created model in real-time, monitoring mixing uniformity and the content of API/excipients in real-time. ■ High-performance MEMS Spectrometer It uses a MEMS spectrometer with a wavelength-variable laser. Excellent optical resolution and low noise allow for high-resolution spectra. ■ Calibration/Scale-up This system was developed in close cooperation with pharmaceutical manufacturers. Scaling up from the lab to the factory is easy. ■ Compliance with GMP / Part 11 Designed for use in the pharmaceutical industry, it can be used in GMP environments. Additionally, the dedicated software SentroSuite complies with 21 CFR Part 11. ■ Features - Lightweight, compact, and easy to install - Smooth surface shape suitable for GMP - Accurate and reliable near-infrared technology - Excellent spectral performance - Low cost - No data loss during communication failures - OPC connection available - SiPAT interface
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basic information
● Wavelength range: 1350–1800nm ● Spectral resolution: >=0.3 nm (configurable), specification is 2 nm ● Wavelength accuracy: < 1nm ● Wavelength reproducibility: < 0.1nm ● Data acquisition time: 400msec ● Sampling: Contactless, using sapphire window ● Measurement spot size: Uniform beam shape of 25mm ● Effective detection area: Diameter 12mm ● Operating distance: 8.5mm ● Power supply: Hot-swappable battery x2 (operates for over five hours), external power supply (for laboratory, during charging) ● Device housing: IP65 / NEMA4, compliant with cGMP ● Dimensions: 220 x 210 x 150mm (W x D x H) ● Width: Additional 80mm (handle part) ● Height: Additional 50mm (flange part) ● Weight: 6.5Kg ● Measurement trigger: 3-axis position measurement control by built-in software ● Communication: Wireless LAN (802.11 b/g/n) ● Software: SentroSuite GmP ● Validation: Routine validation compliant with USP<1119> and EP2.2.40 by software
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Applications/Examples of results
It is used in the mixing process with a container blender in the manufacturing process of solid pharmaceutical formulations. Since it is a product from Germany, there are numerous achievements with pharmaceutical manufacturers in Europe and the United States. Deliveries have also started in Japan, and it is currently operational on the production line.
Detailed information
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It is attached to a rotating container. It is used by being directly attached to the rotating container. The measurement data is transmitted wirelessly to the base station PC, allowing real-time monitoring of the data.
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Dedicated software SentroSuite GMP is compliant with 21 CFR Part 11. It handles MBSD settings, real-time operation of predictive models, equipment maintenance, audit trails, and user management.
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Company information
P.I.E Co., Ltd. is the exclusive distributor in Japan for Sentronic GmbH, based in Dresden, Germany. We provide everything from product demonstrations to IQ/OQ and after-sales maintenance. We promote Process Analytical Technology (PAT) using near-infrared (NIR) spectroscopy and support the realization of Quality by Design (QbD). Founded in 1993 in Dresden, Germany, Sentronic consists of two divisions: spectroscopy and optical sensors. The spectroscopy division offers various customer-specific industrial solutions based on NIR and UV/VIS spectral technologies. Sentronic is a system integrator that provides PAT solutions to pharmaceutical, chemical, and food factories. All aspects from product development and manufacturing to software development are conducted in-house. Custom system development tailored to customer requirements is also possible.