Process Analytical Technology Solutions

Malvern Instruments' systems deliver industrially relevant information on particle characterisation, rheological properties; chemical composition and spatial distribution that can help you comply with the US FDA's process analytical technology (PAT) initiative to make your manufacturing processes more efficient and predictable.

Introduced as part of the FDA’s current good manufacturing practices (cGMP) program, the PAT initiative is the pharmaceutical industry’s drive to provide real-time information to characterise and control process variation and manufacturing capability.

The PAT initiative aims to move the pharmaceutical industry towards continuous quality assurance and an endpoint approach to manufacturing – for example granulation is stopped when the optimum granulation size is reached and blending is finished when the blend becomes uniform.

Products such as Malvern’s Insitec on-line particle size analysers and Morphologi G3 and Sysmex FPIA-3000 particle size and shape analysers and the spectral dimensions NIR-CI 2400 and NIR-CI 1700 chemical imaging systems provide important insights into and understanding of many particulate processing issues in the pharmaceutical industry.