System and method for simulation, modeling and scheduling of equipment maintenance and calibration in biopharmaceutical batch process manufacturing facilities

A computer program product comprising a computer usable medium having computer readable program code means embodied in said medium for causing an application program to execute on a computer that simulates equipment maintenance in a biopharmaceutical production process, said computer readable program code means comprising:

• first computer readable program code means for causing the computer to access an equipment list, said list comprising each piece of equipment necessary to perform required tasks in a unit operation of the biopharmaceutical production process and a set of functional specifications for each of said pieces of equipment;
• second computer readable program code means for causing the computer to access an equipment data store, said data store comprising maintenance data for each of said pieces of equipment in said equipment list;
• third computer readable program code means for causing the computer to generate, using said equipment list and said equipment data store, an equipment maintenance table, said maintenance table including maintenance procedures, period and duration for each of said pieces of equipment;
• fourth computer readable program code means for causing the computer to access an equipment time line which includes the start and stop times for the required tasks in said unit operation of the biopharmaceutical production process;
• and
• fifth computer readable program code means for causing the computer to generate, using said equipment maintenance table and said equipment time line, an equipment maintenance time line which indicates the specific time and date when each of said pieces of equipment should be serviced;
• wherein said equipment maintenance time line contains information that can be used to determine an optimal design for a biopharmaceutical batch process manufacturing facility where said unit operation will be performed.

A computer-implemented method for simulating equipment calibration in a biopharmaceutical production process, comprising the steps of:

• (1) accessing an equipment list, said list comprising each piece of equipment necessary to perform required tasks in a unit operation of the biopharmaceutical production process and a set of functional specifications for each of said pieces of equipment;
• (2) accessing an equipment data store, said data store comprising calibration data for each of said pieces of equipment in said equipment list;
• (3) generating, using said equipment list and said equipment data store, an equipment calibration table, said calibration table including calibration procedures, period and duration for each of said pieces of equipment;
• (4) accessing an equipment time line which includes the start and stop times for the required tasks in said unit operation of the biopharmaceutical production process;
• and
• (5) generating, using said equipment calibration table and said equipment time line, an equipment calibration time line which indicates the specific time and date when each of said pieces of equipment should be calibrated;
• wherein said equipment calibration time line contains information that can be used to determine an optimal design for a biopharmaceutical batch process manufacturing facility where said unit operation will be performed.

A computer program product comprising a computer usable medium having computer readable program code means embodied in said medium for causing an application program to execute on a computer that simulates equipment calibration in a biopharmaceutical production process, said computer readable program code means comprising:

• first computer readable program code means for causing the computer to access an equipment list, said list comprising each piece of equipment necessary to perform required tasks in a unit operation of the biopharmaceutical production process and a set of functional specifications for each of said pieces of equipment;
• second computer readable program code means for causing the computer to access an equipment data store, said data store comprising calibration data for each of said pieces of equipment in said equipment list;
• third computer readable program code means for causing the computer to generate, using said equipment list and said equipment data store, an equipment calibration table, said calibration table including calibration procedures, period and duration for each of said pieces of equipment;
• fourth computer readable program code means for causing the computer to access an equipment time line which includes the start and stop times for the required tasks in said unit operation of the biopharmaceutical production process;
• and
• fifth computer readable program code means for causing the computer to generate, using said equipment calibration table and said equipment time line, an equipment calibration time line which indicates the specific time and date when each of said pieces of equipment should be calibrated;
• wherein said equipment calibration time line contains information that can be used to determine an optimal design for a biopharmaceutical batch process manufacturing facility where said unit operation will be performed.