Apparatus for monitoring pharmaceutical manufacturing processes

• US 9,008,815 B2
• Filed: 08/20/2010
• Issued: 04/14/2015
• 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:
  US12/806,776
• Publication Number:
  US 20110046770A1
• Time in Patent Office: 1,698 Days
• Field of Search: 700108-110, 700/266, 702182-184, 702/187
• US Class Current: 700/108
• 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

An apparatus for 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. An apparatus comprising,

a) a non-transitory computer memory having computer executable instructions adapted for use in a pharmaceutical manufacturing process wherein an active pharmaceutical ingredient but not an inactive pharmaceutical ingredient is produced, and wherein said non-transitory computer memory having computer executable instructions is used in monitoring data compiled during said pharmaceutical manufacturing process, wherein said monitoring occurs at a critical control point, and wherein said critical control point relates to a function in said pharmaceutical manufacturing process that has an adverse affect on the quality of said active pharmaceutical ingredient;

b) a controller;

c) a database, wherein said database stores said data over time to provide a historic record of said pharmaceutical manufacturing process;

d) a plurality of devices adapted for use in a pharmaceutical manufacturing process wherein an active pharmaceutical ingredient but not an inactive pharmaceutical ingredient is produced and wherein said devices are integrated with said non-transitory computer memory having computer executable instructions on a device by device basis.

2. The apparatus of claim 1, wherein said pharmaceutical manufacturing process is a batch pharmaceutical manufacturing process.

3. The apparatus of claim 1, wherein said controller is a programmable logic controller.

4. The apparatus of claim 1, wherein said database is a relational database.

5. The apparatus of claim 1, wherein said active pharmaceutical ingredient consists of an in-process material.

6. The apparatus of claim 1, wherein said device is a blender.

7. The apparatus of claim 1, wherein said device is a clean-in-place system.

8. The apparatus of claim 1, wherein said device is a modular cleanroom.

9. The apparatus of claim 1, wherein said device is a vessel.

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

11. The apparatus of claim 1, wherein said device is a solvent recovery system.

12. The apparatus of claim 1, wherein said device is a time-stamped audit trail.

13. The apparatus of claim 1, wherein said device is a barcode.

14. The apparatus of claim 1, wherein said device is a chromatography/separation system.

15. The apparatus of claim 1, wherein said device is a LAN.

16. The apparatus of claim 1, wherein said device is fermentation equipment.

17. An article of manufacture comprising the apparatus of claim 1.