Methods of performing path analysis on pharmaceutical manufacturing systems

• US 20070198116A1
• Filed: 04/12/2007
• Published: 08/23/2007
• Est. Priority Date: 05/06/2004
• Status: Active Grant

• Current Assignee: SMP Logic Systems LLC
• Original Assignee: SMP Logic Systems LLC
• Inventors: Popp, Shane
• Granted Patent: US 7,428,442 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 performing path analysis on pharmaceutical manufacturing systems are described and disclosed herein. Consequently, the methods provide a means to perform validation and quality control on an integrated level whereby a pharmaceutical manufacturer can ensure data and product integrity and minimize cost.

Claims

13. ) A method of performing a path analysis on a pharmaceutical manufacturing system, said method comprising,

a) deriving an algorithm that performs path analysis on said pharmaceutical manufacturing system;

b) performing logic analysis on said algorithm;

c) integrating said algorithm into a pharmaceutical manufacturing system whereby the path is validated and whereby actual control of said manufacturing process is attained.

14. ) The method of claim 13, wherein the pharmaceutical manufacturing occurs in a clinical manufacturing process.

15. ) The method of claim 13, wherein the pharmaceutical manufacturing occurs in a commercial manufacturing process.

16. ) The method of claim 13, wherein the analysis is performed on pharmaceutical manufacturing hardware system.

17. ) The method of claim 13, wherein the analysis is performed on pharmaceutical manufacturing software system.

18. ) A computer memory having computer executable instructions to perform the method of claim 13.

19. ) A kit comprising the computer memory having computer executable instructions of claim 18.