SYSTEM AND METHOD FOR SIMULATION, MODELING AND SCHEDULING OF PROCESS SUPPORT OPERATIONS IN BIOPHARMACEUTICAL BATCH PROCESS MANUFACTURING FACILITIES

摘要

A system and method for simulation, modeling and scheduling of process support operations in a biopharmaceutical manufacturing facility. The process support operations include those associated with the batch production facility (e.g., equipment maintenance and calibration, and quality control sampling and testing) and those associated with the biopharmaceutical batch production process within the facility (e.g., solution and equipment preparation). The system and method, for process support operations associated with the manufacturing facility include the steps of identifying relevant data (e.g., maintenance, calibration, or testing) associated with the biopharmaceutical production process equipment. After the data are identified, biopharmaceutical production process equipment is used to generate a table of equipment and associated data. The table of equipment and data is then compared with a procedure time line to determine the scheduling of the tasks for the equipment in the biopharmaceutical production process. For process support operations associated with the manufacturing process within the facility, the system and method include the steps of identifying the solution and its volume, or identifying the soiled equipment and its preparation procedures. After identification, scheduling information is identified based on solution start dates or equipment protocols. The duration of the solution preparation procedure is then determined based on preparation vessel assignment and the scheduling information. An equipment preparation time line is also generated based on the size and capacity of the preparation equipment and the scheduling information.