Operational Excellence & Lean Six Sigma Model directly whenever possible; don’t model operations that reference operating parameters from other areas of the process. In the case of purification, start with the chromatography, viral filtration and ultrafiltration systems, rather than from the buffer preparation and buffer hold systems, which reference data from other areas of the process. For example, buffer hold tanks that feed chromatography systems get their pull-out durations and volumes of buffer fed to the chromatography columns from the chromatography system itself. Operating parameters such as the column volume, linear velocity and equipment details determine the amount of buffer supplied to the chromatography system and the pull-out durations. In contrast, modeling the buffer hold tank first would require inputs to be re-entered or scheduling links to be re-established once the chromatography system had been built into the model. Establish templates that can be used for similar unit operations. Once a unit operation has been set up, data can easily be copied and pasted into the modeling flowsheet to model another similar or identical unit. All of the activities of the first unit operation will copy to the second, but remember that activities with external references will need to be set up again. Once the product path has been modeled, move on to other areas in the process. Now is the time to model buffer preparation and hold areas. But there are ways to reduce the time entailed. Again, templates can be established for equipment that is used several times during each product batch. Consider a tank used in buffer preparation. This tank may be shown on the model flowsheet multiple times to signify that multiple buffer batches are made in that tank. Assigning the same equipment tag number to a tank that is used multiple times in the process accounts
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