NIR Spectroscopy for Assessing Blend Uniformity in the Pharmaceutical Industry
Technological advancements in Near Infrared (NIR) instrumentation have resulted in a move from the laboratory to the manufacturing environment in a form factor suitable for process monitoring and control applications.
Blend uniformity is considered as a Critical Quality Attribute (CQA) by regulatory authorities as it is a key indicator of final tablet uniformity. Traditional methods of analysis are invasive and non-representative. NIR is non-invasive, non-destructive and is much more representative as it measures the state of the material as it exists in the process.
This webinar presented the use of MicroNIR PAT for monitoring the endpoint of powder blending operations using a number of examples and discussed the implementation challenges that need to be addressed for successful implementation. This webinar also described the use of NIR as a continuous verification method that aligns with the principles of Quality by Design as defined in the 2011 US FDA Process Validation guideline.
Brad Swarbrick, Owner, Quality by Design Consultancy
Brad Swarbrick is a recognized expert in the application of NIR systems and Chemometrics control strategies into the pharmaceutical industry. Working with many of the leading pharmaceutical manufacturers, Brad has implemented NIR into many processes in a diverse number of applications.
Supported by Viavi Solutions Inc.
Viavi helps ensure top performance in virtually every major network—from the NOC to field technicians—and over 100,000 data centers worldwide, from deployment and installation to monitoring and optimisation. For nearly 100 years, Viavi has innovated solutions to optimise communications technologies, from simple radio test sets to sophisticated network assurance platforms. Always an industry leader, the company has consistently complemented its strong R&D roots with smart, strategic acquisitions and mergers.
Find out more: www.viavisolutions.com