Methods of integrating computer products with pharmaceutical manufacturing hardware systems

• US 20070288114A1
• Filed: 04/12/2007
• Published: 12/13/2007
• 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 7,392,107 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 integrating computer products with pharmaceutical manufacturing hardware 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

1. ) A method of integrating a computer product with a pharmaceutical manufacturing hardware system said method comprising,

a) contacting the computer product to a hardware device used in pharmaceutical manufacture;

b) monitoring data generated by the hardware device during pharmaceutical manufacture;

c) maintaining the data over time to provide a historical record;

d) analyzing the historical record to provide a risk-based assessment in case of failure;

e) taking corrective action to obviate the failure whereby said corrective action comprises stopping or modifying said pharmaceutical manufacture.

2. The method of claim 1, wherein the hardware device is selected from the group consisting of blenders, bio-reactors, capping machines, chromatography systems, dry heat sterilizers, freezers, filling equipment, filtration systems, incubators, labelers, dryers, mixing tanks, modular cleanrooms, neutralization systems, process tanks, vessels, refrigerators, separation systems, specialty gas systems, solvent recovery systems, waste inactivation systems/“

kill”

systems, vial inspection systems, vial washers, water for injection (WFI) systems, and pure water systems.

3. The method of claim 1, whereby the integration occurs at initial process.

4. The method of claim 1, whereby the integration occurs at end process.

5. The method of claim 1, wherein the monitoring is part of routine maintenance to assure conformance with pharmaceutical manufacturing Quality control.

6. The method of claim 1, wherein the data is generated by an analysis selected from the group consisting of boundary value analysis, branch analysis, control flow analysis, failure analysis, failure modes and effects analysis, and path analysis.

7. A computer memory having computer executable instructions to perform the method of claim 1.

8. A kit comprising the computer memory having computer executable instructions of claim 7.