Diode-array-based NIR analyser for pharmaceutical powder blending
SentroPAT DA is a dedicated NIR analyser 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. This extremely compact system with its very low weight fits many sizes of blenders.
The process connection is made by a separate process flange with an integrated sapphire window. This flange is welded into the bin wall or into the bin lid. The inside surface is flush to process side thus there is no impedance to the material flow.
The heart of the instrument is a rugged and proven InGaAs diode array spectrometer. High spectral resolution and wave length 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.
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 and therefor raise production costs.Fully implemented and applied, the online monitoring of blend uniformity is a key element for real-time release.
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 it is required for use in GMP production facilities.
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.