Venue details  Please note that to attend our seminar you will also have to register with Pharamatex but entrance into the exhibition area and our seminar is free.

Near Infrared Analysis as a Process Analytical Technology (PAT) Tool for the
Pharmaceutical and Bio-pharmaceutical Industries

PAT is a system for designing, analysing and controlling manufacturing through timely measurements, i.e. during processing, of critical quality and performance attributes of raw and in-process materials and processes with the goal of ensuring final product quality. In-process testing that currently exists in pharmaceutical manufacturing consists of: physical measurements or results from samples sent to the lab while processes are halted or continued ‘blindly’. Current testing is not real-time, nor ‘whole batch’ and non-optimal conditions can still occur; over-blending for example. Testing and waiting for results is costly.

Near infrared (NIR) spectroscopy can measure organic materials non-destructively and often non-invasively and is very suitable for in-process analysis of pharmaceutical and bio-pharmaceutical materials. NIR spectroscopy is often used to measure moisture, active concentration, purity, homogeneity, morphology and crystallinity. The technique is also sensitive to physical parameters such as particle size. Typical applications are monitoring synthetic reactions, drying and blending processes. Since the technique works with overtones of molecular vibrations, aqueous bioprocesses can be monitored directly. Input to processes can also be monitored by NIR spectroscopy. For example, the quality of raw materials entering a process is a key parameter of on-going ‘processability’ of the product. Moisture content and particle size will impact the blending step of a process.

NIR spectroscopy is an ideal tool to aid the understanding and improvement of pharmaceutical and bio-pharmaceutical processes