Monitoring pharmaceutical manufacturing processes

• US 9,195,228 B2
• Filed: 08/20/2010
• Issued: 11/24/2015
• 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): Shechtman, Sean
• Assistant Examiner(s): GARLAND, STEVEN R
• Application Number:
  US12/806,837
• Publication Number:
  US 20100324716A1
• Time in Patent Office: 1,922 Days
• Field of Search: 700108-110, 700/266, 702182-184, 702/187
• US Class Current: 1/1
• 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 compiled by a device adapted for use in a pharmaceutical manufacturing process that produces an active ingredient during pharmaceutical manufacture, wherein said active ingredient furnishes a pharmacological effect, wherein said device is located at a critical control point in said pharmaceutical manufacturing process;

b) creating a historic record of the pharmaceutical manufacturing process that produces said active ingredient wherein said historic data comprises said data compiled by said device adapted for use in a pharmaceutical manufacturing processes that produce said active ingredient;

c) providing the historic record to an end user;

d) analyzing the data associated with the device to determine whether an acceptance criteria that relates to said active ingredient has been achieved, wherein said acceptance criteria relates to an acceptable quality level or an unacceptable quality level, necessary to accept or reject a lot or a batch of said active ingredient.

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 non-transitory computer memory having computer readable instructions which performs the method of claim 1.

19. An article of manufacture comprising the non-transitory computer memory having computer readable instructions of claim 18.