Methods, systems, and software program for validation and monitoring of pharmaceutical manufacturing processes

• US 7,471,991 B2
• Filed: 08/08/2006
• Issued: 12/30/2008
• 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.
• Primary Examiner(s): DeCady; Albert
• Assistant Examiner(s): Garland; Steven R
• Application Number:
  US11/500,642
• Publication Number:
  US 20060271227A1
• Time in Patent Office: 875 Days
• Field of Search: 700/108, 700/109, 705 1- 3
• 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 for performing boundary value analysis on a pharmaceutical manufacturing process are described and disclosed herein. The algorithm performing the boundary value analysis is integrated into a pharmaceutical manufacturing process and control of the pharmaceutical manufacturing process is attained. Consequently, the methods provide a means to manufacture pharmaceuticals on an integrated level whereby data and product integrity are achieved and over time costs are minimized.

Claims

1. A method for monitoring a pharmaceutical manufacturing process, said method comprising:

a) deriving an algorithm implemented in computer executable instructions that performs “

boundary value analysis”

on a pharmaceutical manufacturing hardware system using at least a filtration/purification system;

b) performing “

logic analysis”

on said algorithm;

c) integrating said algorithm implemented in computer executable instructions into said pharmaceutical manufacturing hardware system wherein boundary values are selected;

d) monitoring said pharmaceutical manufacturing hardware system.

2. The method of claim 1, wherein the pharmaceutical manufacturing occurs in a clinical manufacturing process.

3. The method of claim 1, wherein the pharmaceutical manufacturing occurs m a commercial manufacturing process.

4. A method for monitoring a pharmaceutical manufacturing process, said method comprising:

a) deriving an algorithm implemented in computer executable instructions that performs “

boundary value analysis”

on a a pharmaceutical manufacturing hardware system using at least a blender;

b) performing “

logic analysis”

on said algorithm;

c) integrating said algorithm implemented in computer executable instructions into said pharmaceutical manufacturing hardware system wherein boundary values are selected;

d) monitoring said pharmaceutical manufacturing hardware system.

5. The method of claim 4, wherein the pharmaceutical manufacturing occurs in a commercial manufacturing process.

6. A method for monitoring a pharmaceutical manufacturing process, said method comprising:

a) deriving an algorithm implemented in computer executable instructions that performs “

boundary value analysis”

on a a pharmaceutical manufacturing hardware system using at least a mixing tank;

b) performing “

logic analysis”

on said algorithm;

c) integrating said algorithm implemented in computer executable instructions into said pharmaceutical manufacturing hardware system wherein boundary values are selected;

d) monitoring said pharmaceutical manufacturing hardware system.

7. The method of claim 6, wherein the pharmaceutical manufacturing occurs in a commercial manufacturing process.

8. A method for monitoring a pharmaceutical manufacturing process, said method comprising:

a) deriving an algorithm implemented in computer executable instructions that performs “

boundary value analysis”

on a pharmaceutical manufacturing hardware system using at least a pure water system;

b) performing “

logic analysis”

on said algorithm;

c) integrating said algorithm implemented in computer executable instructions into said pharmaceutical manufacturing hardware system wherein boundary values are selected;

d) monitoring said pharmaceutical manufacturing hardware system.

9. The method of claim 8, wherein the pharmaceutical manufacturing occurs in a commercial manufacturing process.

10. A method for monitoring a pharmaceutical manufacturing process, said method comprising:

a) deriving an algorithm implemented in computer executable instructions that performs “

boundary value analysis”

on a pharmaceutical manufacturing hardware system using at least a bioreactor;

b) performing “

logic analysis”

on said algorithm;

c) integrating said algorithm implemented in computer executable instructions into said pharmaceutical manufacturing hardware system wherein boundary values are selected;

d) monitoring said pharmaceutical manufacturing hardware system.

11. The method of claim 10, wherein the pharmaceutical manufacturing occurs in a commercial manufacturing process.