Monitoring pharamceutical manufacturing processes

• US 20100324716A1
• Filed: 08/20/2010
• Published: 12/23/2010
• Est. Priority Date: 05/06/2004
• Status: Active Grant

• Current Assignee: SMP Logic Systems LLC
• Original Assignee: SMP Logic Systems LLC
• Inventors: Popp, Shane M.
• Granted Patent: US 9,195,228 B2
• Time in Patent Office: Days
• US Class Current: 700/110
• CPC Class Codes: G05B 2219/11 Plc I-O input output
• CPC Class Codes: G05B 2219/1112 Bit addressing, handling
• CPC Class Codes: G05B 2223/02 Indirect monitoring, e.g. monitoring production to detect faults of a system
• CPC Class Codes: G05B 23/0224 Process history based detection method, e.g. whereby history implies the availability of large amounts of data
• CPC Class Codes: G05B 23/0235 based on a comparison with predetermined threshold or range, e.g. "classical methods", carried out during normal operation; threshold adaptation or choice; when or how to compare with the threshold
• CPC Class Codes: G06Q 10/06 Resources, workflows, human or project management; Enterprise or organisation planning; Enterprise or organisation modelling

Abstract

Methods of monitoring data generated by a device adapted for use in a pharmaceutical manufacturing environment are described and disclosed herein. The method creates a historic record of the pharmaceutical manufacturing process and provides it to an end user or a plurality of end users. Consequently, the methods provide a means to track the frequency of hazards associated with said device and thereby perform quality control on an integrated level whereby a pharmaceutical manufacturer can ensure data and product integrity and minimize cost.

Claims

1. ) A method comprising,

a) monitoring data generated by a device adapted for use in a pharmaceutical manufacturing process during pharmaceutical manufacture;

b) creating a historic record of the pharmaceutical manufacturing process by maintaining the data over time;

c) providing the historic record to an end user;

d) tracking the data associated with the device to determine a frequency of hazards that relate to said device during pharmaceutical manufacture.

2. ) The method of claim 1, wherein said device is a blender.

3. ) The method of claim 1, wherein said device is a clean-in-place system.

4. ) The method of claim 1, wherein said device is a modular cleanroom.

5. ) The method of claim 1, wherein said device is a vessel.

6. ) The method of claim 1, wherein said device is a water for injection system.

7. ) The method of claim 1, wherein said device is an inactivation system.

8. ) The method of claim 1, wherein said device is filling equipment.

9. ) The method of claim 1, wherein said device is a labeler.

10. ) The method of claim 1, wherein said device is a mixing tank.

11. ) The method of claim 1, wherein said device is a chromatography/separation system.

12. ) The method of claim 1, wherein said device is a filtration/purification system.

13. ) The method of claim 1, wherein said device is a capping machine.

14. ) The method of claim 1, wherein said device is a vial washer.

15. ) The method of claim 1, wherein said device is a solvent recovery system.

16. ) The method of claim 1, wherein said device is a bar code system.

17. ) The method of claim 1, wherein said end user is a quality control unit.

18. ) A computer memory having computer readable instructions which performs the method of claim 1.

19. ) A kit comprising the computer memory having computer readable instructions of claim 17.