OVERVIEW

• High performance spectrometer engine, easy to mount
• accurate and reliable NIR technology
• Seamless method transfer between instruments
• GmP friendly with smooth surfaces
• Superior spectroscopic performance
• Low cost of ownership
• Hot swappable battery
• No data loss at communication failure
• OPC connectivity
• SiPAT interface

Applications

Bin Blending Sentronic PAT solutions are widely used in pharmaceutical powder blending to increase process understanding and support process and product release

More Information

SentroPAT BU II

The SentroPAT BU II is a dedicated system for pharmaceutical powder blending. The system helps to understand process variability and critical quality parameters of the powder blending process. It allows to define process end point by product properties instead of "fixed time". The system also enables real time release.

 

Excellent accuracy, stability and high optical resolution allow sensitive monitoring of blend quality. Transferability of calibrations allows to scale up between development, pilot plant and full production.

 

The smooth design of this most compact instrument provides high level of GmP compliance. All surfaces are smooth and can easily wiped.

 

The handling is simple and user friendly. The battery is hot swappable (power is supplied by an additional internal battery). Alternatively it can be recharged in the instrument.

 

Measurement can be triggered by an internal MEMS sensor, which measures analyser orientation. Alternativelly triggering based on the NIR signal is possible.

 

The system incorporates a low power embedded PC running Windows 7 Professional. All measured data are stored in the internal SSD and are save even at communication errors. The use of 2 internal wireless antennas improves communication stability under moving conditions.

 

SentroPAT BU II systems are easy to mount on a wide range of blender systems using a hygienic 4” tri-clamp connector. Sentronic provides process windows and integration support to equipment specific bin lids. Alternatively process windows can be welded into the bin wall. itself.

 

The system is fully validated and comes with IQ/OQ documentation. SentroSuite GmP, 21CFR part11 compliant software is installed on the system and includes automated validation routines for instrument performance.

 

 

 

Technical Data

 

Technical Data	SentroPAT Blend Uniformity TL
Wavelength range	1350 - 1800nm
Spectral resolution	>= 0.3nm (configurable), specification at 2nm
Wavelength accuracy	< 1nm
Wavelength reproducibility	< 0.1nm
Photometric linearity	Fulfilling USP requirements
Noise - High flux	< 0.3 x 10-³ AU according to USP
Noise - Low flux	< 1 x 10-³ AU according to USP
Data acquisition time	400msec
Sampling interface	Non contact, through sapphire window
Measurement spot size	25mm uniform beam shape for homogeneous sample illumination effective detection area 12mm diameter
Working distance	Depending of sapphire window (27mm at 8.5mm sapphire thickness)
Power supply	2 hot swappable batteries with in total > 5hours operation External power supply for lab operation and recharging
Enclosure	IP65 / NEMA4, cGMP conform
Dimensions	220 x 210 x 150mm (W x D x H) Width: add 80mm for handle Height: add 50mm for flange
Weight	6.5Kg / 14.5lb
Measurement trigger	Internal software controlled 3D position measurement
Communications	Wireless LAN (802.11 b/g/n)
Software	SentroSuite GmP
Validation	Software integrated validation routines according USP, EP2.2.40
Service port	Connections for DVI-D monitor and 3x USB
Mounting	4" or 2" hygienic flange

Advantages