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

• US 6,311,093 B1
• Filed: 06/19/1998
• Issued: 10/30/2001
• Est. Priority Date: 06/20/1997
• Status: Expired due to Fees

• Current Assignee: Peter G. Brown
• Original Assignee: Peter G. Brown
• Inventors: Brown, Peter G.
• Primary Examiner(s): Heckler, Thomas M.
• Application Number:
  US09/100,028
• Time in Patent Office: 1,229 Days
• Field of Search: 700/90, 700/95, 700/97, 702/182-184, 702/187
• US Class Current: 700/95
• CPC Class Codes: G05B 17/02 electric
• CPC Class Codes: G05B 2219/32234 Maintenance planning
• CPC Class Codes: G05B 2219/32354 Divide, analyse process into subprocesses, until elementary unit operations
• CPC Class Codes: Y02P 90/02 Total factory control, e.g. smart factories, flexible manufacturing systems [FMS] or integrated manufacturing systems [IMS]
• CPC Class Codes: Y02P 90/80 Management or planning

Abstract

A method and computer program product for simulating, modeling and scheduling equipment maintenance and calibration procedures in a biopharmaceutical production facility is described herein. The method and computer program product includes the steps of identifying maintenance, and maintenance and calibration data associated with biopharmaceutical production process equipment. After the maintenance and calibration data are identified, biopharmaceutical production process equipment is used to generate a table of equipment and maintenance and calibration data. After the table of equipment and data is generated, the table is compared with a procedure time line to determine the schedule of calibration and maintenance for the equipment in the biopharmaceutical production process.

Claims

1. A computer-implemented method for simulating equipment maintenance 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 maintenance 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 maintenance table, said maintenance table including maintenance 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 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.

2. The computer-implemented method of claim 1, wherein said equipment list, said equipment data store, and said equipment time line includes information for at least one of the following types of equipment used in said unit operation of the biopharmaceutical production process:

(i) process equipment;

(ii) preparation equipment; and

(iii) solution preparation equipment.

3. The computer-implemented method of claim 1, wherein one of said pieces of equipment is a pump, and said functional specifications for said pump include at least one of the following specifications:

(i) pump type;

(ii) flow rate;

(iii) maximum and minimum input and output pressures;

(iv) input and output fitting sizes;

(v) electrical requirement;

(vi) temperature range;

(vii) type of required maintenance; and

(viii) frequency of required maintenance.

4. The computer-implemented method of claim 1, wherein said maintenance data in said equipment data store includes at least one of the following types of data for each of said pieces of equipment:

(i) replaceables;

(ii) reusables;

(iii) labor cycle life; and

(iv) maintenance cost.

5. 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.

6. 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.

7. The computer-implemented method of claim 6, wherein said equipment list, said equipment data store, and said equipment time line includes information for at least one of the following types of equipment in the biopharmaceutical production process:

(i) process equipment;

(ii) preparation equipment; and

(iii) solution preparation equipment.

8. The computer-implemented method of claim 6, wherein said calibration data in said equipment data store includes at least one of the following types of data for each of said pieces of equipment:

(i) replaceables;

(ii) reusables;

(iii) labor cycle life; and

(iv) calibration cost.

9. 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.