The Business Benefits of PAT in Continuous Drug Product Manufacturing - Seguridad Mania.com - España y América Latina

It is well recognized that continuous processing requires continuous monitoring, at the “heart-beat” of the process to ensure product quality and patient safety. However, the use of PAT in the optimization of equipment and the development of processes from which a product will be manufactured is also of significant value, and justifies the investment in PAT for a continuous manufacturing. The data density and timeliness can deliver immediate feedback and exquisitely detailed information on the success of processing steps. The gathered information can aid in the establishment of an effective and robust processing regime for new or existing products. This paper will discuss the use of information rich PAT technologies to understand equipment and process steps during development. Examples of equipment characteristics and the effect on the product will be examined. An important area for PAT in continuous manufacturing is cleaning. The equipment trains to be effective must be capable of rapid change over. PAT’s designed for rapid assessment of surface cleanliness are important. Devices that allow rapid cleaning verification will be discussed.