Importance

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Abstract

A system and method for the simulation and modeling of biopharmaceutical batch process manufacturing facilities using process time lines is described herein. The system employs a four-field delimited string code which specifies the unit identifier code and the iteration value for each of the three levels of scheduling cycle--'Unit Operation Cycles,' 'Unit Operation Cluster Cycles,' and 'Batch Cycles'--of the biopharmaceutical drug production process being modeled. The method includes the step of selecting a sequence of unit operations wherein each of the sequence of unit operations has an identifier code. Next, a set of scheduling cycles is selected for each of the sequence of unit operations. A master table is then referenced, using the identifier code, to obtain operational parameters for each of the sequence of unit operations. A block flow diagram is then generated using the sequence of unit operations and the operational parameters. The method further includes generating a process time line using the operational parameters, the block flow diagram, and the set of scheduling cycles for each of the sequence of unit operations. The process time line--a time line for the beginning and ending times of each unit operation and its associated tasks for the entire biopharmaceutical drug production process--is used as a tool for batch processing and facility design.

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First Claim