Near-Infrared Spectrometers – Process Analytical Technology (PAT)
Sentronic offers the best expertise for the Pharmaceutical Solid Dose Continuous Measurement Applications with their NIR Spectrometers. Applications include blend uniformity measurement in bin blender, continuous blender, tablet compression, applications related to fluid bed drying, high shear wet granulation, can also be discussed.
NIR SPECTROMETER & BLENDERS
SentroPAT DA
SentroPAT DA was developed to bring PAT to the blending unit operation. Under QbD risk assessment, the blending of powders is often identified as a critical quality attribute (CQA). Further it can be used as a key enabler of a real-time release approach. SentroPAT DA offers flexible, cost-effective solutions for this application.”
SentroPAT FO
The SentroPAT FO is a compact NIR system utilizing a diode array spectrometer. The optical module is combined with an embedded PC, enabling a direct integration of the system into a network. An internal multiplexer allows the sequential measurement of multiple measurement ports while internal standards ensure long-term stability of PAT measurements
SentroBlender
SentroBlender is a lab scale system dedicated to accelerate development of blend uniformity NIR methods using very low amount of material. The API required, and overall time for preparation, discharging and cleaning can be excessive depending on the size of the blender.
Granulation is a process commonly used in the manufacturing of solid dose pharmaceuticals. The goal of this process is to make product handling easier and to enhance the properties of the starting material for dosage or further processing. Near infrared-based PATcan be applied to monitor dry and wet granulation; providing deep process insights and complex information for the entire process.
Drying:
Whether a wet granulation is performed in a high shear granulator or fluidized bed system, the granules have to be dried before further processing can be undertaken. Drying to a defined level of residual moisture, within a tight tolerance, is often critical for this process. Applying near infrared-based PAT to a drying process enables a direct measurement of the moisture in real time and avoids
the need for sampling and possible extended processing.
Blending of powders to a homogeneous mixture is a critical step in most manufacturing processes for solid dose pharmaceuticals. Real-time assessment of blend uniformity by NIR spectroscopy is a common application of PAT. The SentroPAT BU has been used for this application in conjunction with a wide range of different models of IBC’s or blending systems.
Compression :
Recently, the installation of the SentroProbe DR LS NIR in the feed frame of a tablet press has been a popular solution for deploying PAT in solid dose pharmaceutical manufacturing. Analyzing material in the feed frame allows for process monitoring and control with measurements that are representative of material in the final tablet.
The PAT systems and probes offered by Sentronic can be controlled by the software SentroSuite GMP. This comprehensive software package was developed according to GAMP5 and is compliant with the requirements defined in 21CFR part 11. To enable the integration of Sentronic PAT systems into a complex manufacturing environment, an OPC DA server is provided and allows communication to and with SIPAT, SynTQ, PharmaMV or Process Pulse. Embedded libraries for real-time predictions can be added optionally and are available for PLS models generated with SIMCA or Unscrambler.
Get in touch with our team to know more about it.