Current State of PAT Applications for a Reliable and Effective PCM...

Presented by

Richard Steiner, Senior Manager Business Strategy at Pharmatech Associates, A USP Company

About this talk

Full title: Current State of PAT Applications for a Reliable and Effective PCM Equipment Operation PAT is an integral part of every Pharmaceutical Continuous Manufacturing (PCM) control strategy. On the other hand, PAT sensors can cause equipment and process inefficiencies due to the complex nature of those instruments. Sensor technology, data volume, sensor maintenance or the interface to the process contribute to operational complexity. Nonetheless, PAT is required to measure Critical to Quality product Attributes (CQA), on-line or at-line and is enabling Real Time Release strategies. Furthermore, PAT sensors are also used during process and predictive model development, CQA monitoring, diverting Out of Specification (OOS) material and thus are essential for Real time Release testing applications. Consequently, the selection of PAT applications is a critical step in every PCM business case assessment and during the entire engineering phase of a PCM system. This presentation will provide an overview of commonly used PAT sensor technologies and their selection criteria. Furthermore, it will revisit process design criteria for the optimal positioning of those sensors within the given process flow. The overall control strategy defines what level of PAT implementation is necessary to run a successful continuous operation. All examples will be supported by real world PAT applications in operating PCM installations. Finally, this presentation should provide confidence in available PAT technologies. Innovation will aim for new even more sophisticated sensor technologies and new analytical software tools, but today PCM drug substances and drug product applications are covered and allow lead users to achieve the expected Overall Equipment Effectiveness (OEE) and required Net Present Value (NPV).
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