brochure du sentropat da, analyseur NIR pour le mélange de poudres pharmaceutiques

Diode-array-based NIR analyzer for pharmaceutical powder blending: SentroPAT DA

SentroPAT DA is a dedicated NIR analyzer for non-invasive online monitoring of pharmaceutical powder bin blending. The system provides valuable process insight from product development to operations and can also be used to control blend time. The extremely compact system with its very low weight fits many sizes of blenders.

High performance diode array spectrometer

The heart of the instrument is a rugged and proven InGaAs diode array spectrometer. High spectral resolution and wavelength accuracy combined with low noise enable the use in demanding applications. Superior system-to-system comparability simplifies method transfer between instruments. Long-term wavelength and temperature stability is achieved through the use of proprietary internal standards.

Understand and control the blending process

In addition to determining the blending end-point by statistical methods, it is possible to also perform quantitative analysis of the potency of APIs or other blend constituents using chemometric models. Based on the process knowledge gained through NIR analysis, it is possible to optimize blend time, avoid faulty batches and prevent segregation due to over-blending. There is no longer a need for conventional sampling and laboratory analysis, which impede manufacturing processes.

Flexibility and easiest handling

Focus areas of design and development from the very outset were ease-of-use and minimum maintenance time:

• Mounting to the blender is done by means of a simple 2” or 4” sanitary flange.
• Recharge the battery using the system's power adapter.
• The internal 3-axis accelerometer allows software adjustable and reliable measurement synchronization to the blender rotation.
• The smooth surfaces of the unit can be easily cleaned, as required for use in GMP production facilities.

Highest data integrity

Data integrity is supported by the embedded system, where all generated data are buffered locally on the analyzer before transmission through the WiFi connection. The system supports integration to plant-level IT and controls via OPC-server or interfaces to SIPAT or SynTQ.

Technical Parameters

• Detector: 512 pixel linear InGaAs array
• Wavelength range: 1?100–1?900 nm
• Spectral resolution (FWHM): approx. 10 nm
• Wavelength accuracy: < 1 nm
• Wavelength reproducibility: < 0.2 nm
• Internal reference: Internal intensity reference
• Photometric linearity: Fulfilling USP and EP 2.2.40 requirements
• Noise - High flux: according to USP and EP 2.2.40
• Noise - Low flux: according to USP and EP 2.2.40
• Light source: 2 x 5 W used redundantly, maintenance-free
• Data acquisition time: < 1 s (configurable, typically 0.5 s)
• Sampling interface: Non-contact, through sapphire window
• Measurement spot size: approx. 10 mm diameter
• Measurement trigger: software controlled by 3-axis accelerometer, synchronized to blender rotation
• Power supply: replaceable Li-Ion battery, > 6hrs operation. External power supply (24 VDC) for lab operation and recharging
• Enclosure: IP65 / NEMA4, cGMP conform, Aluminum anodized
• Dimensions: 170 x 105 x 60 mm (W x D x H) Height: add 36 mm for flange
• Weight: 2.2 kgs including battery
• Communications: WiFi (802.11 a/g/n)
• Software: SentroSuite GMP on external PC
• Validation: Software integrated validation routines according to USP, EP 2.2.40
• Mounting: 4” or 2” sanitary flange

Sentronic GmbH Information

Since 1993, Sentronic has been successfully developing and manufacturing optical sensors and analyzers, primarily for chemical parameters. With core competence in photonics, combining optical technologies and microelectronics, we supply high-tech products combined with comprehensive services. Our focus is on the development and manufacturing of complete optical sensor and analyzer solutions for the pharmaceutical, chemical, and life science industry. We provide flexibility in customizing as well as OEM products. The business unit analyzer is a partner for NIR based PAT solutions in the pharmaceutical industry with a strong focus on solid dose manufacturing processes.

Partnership with Sentronic

Sentronic has implemented end-to-end, fully compliant documentation across the entire product life cycle for many customers and projects. We are an experienced, flexible partner, understanding that each customer has specific needs and imperatives, and we develop made-to-measure answers to the challenges of each PAT project. We are happy to support existing organizational structures, providing vital input. You can be sure of effective communications and quick, easy access to expert advice.

For more information, contact Sentronic GmbH at:

• Address: Gostritzer Strasse 63, D-01217 Dresden, Germany
• Phone: +49 (0) 351 / 8718653
• Email: info@sentronic.eu

Sentronic US Corp.: 251 Little Falls Drive, Wilmington, DE 19808, USA

• Phone: +1 781-859-8483
• Email: info@sentronic.us.com

© Sentronic 02/2018; Doc. No. A54000218001

While we make all efforts to ensure accuracy, we cannot accept liability for the information provided in this document. Technical specifications are subject to change without notice.