SentroPAT BU II is a dedicated on-line solution for the monitoring of pharmaceutical blending in bins. The NIRS-based turnkey solution can provide valuable process insight at every stage of development and can even be an input for RTRT. Due to its compact size and low weight, the system can be easily mounted to a wide range of blenders and containers.
High Performance MEMS Spectrometer
The heart of the instrument is a tunable laser-based MEMS spectrometer. High analytical sensitivity is achieved by the combination of superior optical resolution and low noise. Outstanding system-to-system comparability simplifies method transfer between different blender types, processes, and instruments.
Control the Blending Process
Besides determination of blending end point by statistical methods, quantitative analysis of API and other formulation ingredients by applying chemometric calibrations is possible, too. Based on the additional process knowledge, it is possible to optimize blending time, avoid faulty batches and prevent blends from being segregated due to over-blending. There is no longer need for conventional thief sampling and laboratory analysis, both of which delay manufacturing. Fully implemented and applied, the online monitoring of blend uniformity can be one key element for real-time release.
Flexibility and Ease of Handling
A key focus of design and development from the very outset was ease of use and minimum maintenance effort:
- Mounting can be done by means of a simple 4” hygienic flange
- Hot swappable batteries and internal, as well as external charger, provide outstanding battery life for wireless operation for at least 5 hours of use
- The 3D orientation sensor allows software adjustable and reliable measurement synchronization to the blender rotation.
- The housing of the system can be easily cleaned, as required for use in GMP production facilities.
Ensure Data Integrity
Measurement data integrity is ensured by the use of an embedded PC running Windows 10. All data is stored locally on
the analyzer, before transmission through the wireless network. Standard PC peripherals can be directly attached for service or
IT administration. Wireless Ethernet connectivity and an OPC server are provided for communication in the process environment.