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MAR-APR 2019

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20 INTECH MARCH/APRIL 2019 WWW.ISA.ORG PROCESS AUTOMATION l Connecting disparate data sources: Encompassing all relevant informa- tion, including process operations data and process analytical instru- ment data l Investigation: Having the full range of data signals available for each process, batch, or asset readily available to: — cleanse data — add and remove datasets of interest — define periods of interest using capsule logic — perform profile searches to teach and find similar performance l Advanced analytics to analyze and develop models: Using built-in and user-friendly tools for initial calcula- tions and immediate application to new batches l Construction of a full process train view: Comparing multiple differ- ent unit operations side by side to understand the effect of upstream changes on downstream operations l Workflow documentation: Using journaling, annotation, and lab note- book functionalities to capture criti- cal steps in the workflow l Knowledge management: Commu- nicating key results in a report con- taining a dashboard of current or previous batches or runs. Case study A: Robust facilities operation When operating a pharmaceutical- grade water system, it is imperative to have a direct line of sight to the cur- rent data and the historic trends. This requires continuous availability of pro- cess operations data and real-time par- ticle and biologic counts. Benefits of using a well-defined PAT methodology in this case study include: l enhanced quality assurance l improved risk management l energy savings l reduced resource and labor require- ments l extended facility and equipment life In this example, an online water bio- burden analyzer was the primary pro- cess analytical instrument. This online and real-time technology simultane- ously detected particles and determined biologic counts without requiring stain- ing or reagents, or export of the data for upload into a process data historian. With connection to all relevant data established, the organization performed analysis using advanced analytics software to quickly iden- tify time periods outside sanitization cycles and tank filling cycles to assess the impact on bioburden and particle counts (figure 5). From these obser- vations, statistical models were built, and 3 Sigma boundaries created to represent a robust operating space. To share the results, the organization documented workflows in Seeq Jour- nal and created a dashboard in an Or- ganizer Topic. Figure 5. Water system operation case study showing (a) an overview of how the PAT methodology is applied to a facility's water system operation and (b) key outputs from an analysis illustrating an optimized water system, including the use of Seeq Workbench for analysis and Organizer Topics to summarize and share learnings with the broader organization. Facility operation:

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