Cloud-Controlled Manufacturing Execution System (CLO-cMES) for use in pharmaceutical manufacturing process control, methods, and systems thereof

• US 20200133224A1
• Filed: 10/25/2018
• Published: 04/30/2020
• Est. Priority Date: 10/25/2018
• Status: Active Grant

• Current Assignee: SMP Logic Systems LLC
• Original Assignee: SMP Logic Systems LLC
• Inventors: Popp, Shane M.
• Granted Patent: US 11,754,991 B2
• Time in Patent Office: Days
• CPC Class Codes: G05B 19/056 Programming the PLC
• CPC Class Codes: G05B 19/188 characterised by special applications and not provided for in the relevant subclasses, (e.g. making dies, filament winding)
• CPC Class Codes: G05B 19/4083 Adapting programme, configuration
• CPC Class Codes: G05B 2219/31372 Mes manufacturing execution system
• CPC Class Codes: G05B 2219/31449 Monitor workflow, to optimize business, industrial processes
• CPC Class Codes: G05B 2219/33192 Radio link, wireless
• CPC Class Codes: Y02P 90/02 Total factory control, e.g. smart factories, flexible manufacturing systems [FMS] or integrated manufacturing systems [IMS]

Abstract

“Cloud” based manufacturing execution systems (“MES”) and methods thereof used to control, execute, and monitor pharmaceutical or biopharmaceutical production processes and systems are disclosed herein. Consequently, the methods and systems provide a means to quality manufacturing on an integrated level whereby drug or biologic manufacturers can achieve data and product integrity and ultimately minimize cost.

Claims

1. ) An apparatus comprising,

a) a wireless distributed control system;

b) a manufacturing execution system (MES);

c) a software based programmable logic controller; and

d) a device used to manufacture a pharmaceutical or biopharmaceutical.

2. ) The wireless distributed control system of claim 1, further comprising a plurality of remote data storage servers.

3. ) The wireless distributed control system of claim 1, further comprising a plurality of remote application servers.

4. ) The wireless distributed control system of claim 1, further comprises a fully connected network topography.

5. ) The manufacturing execution system of claim 1, wherein the manufacturing execution system comprises a single layer.

6. ) The software based programmable logic controller of claim 1, wherein the software based programmable logic controller is integrated into the manufacturing execution system.

7. ) The software based programmable logic controller of claim 1, wherein the software based programmable logic controller is integrated into the remote application server.

8. ) The device used to manufacture a pharmaceutical or biopharmaceutical of claim 1, wherein said devices are selected from the group consisting of powder blending systems, granulation systems, crystallization systems, tablet presses, chromatography systems, pH systems, liquid mixing systems, water-based systems, finishing and packaging systems, cell culture systems, filtration/purification systems, centrifugation systems, vial inactivation systems, field instrumentation components and operational units, blenders, bioreactors, capping machines, separation systems, chilled water/circulating systems, glycol systems, modular coldrooms, clean steam systems, clean-in-place (CIP) devices, compressed air systems, D.I./R.O. water systems, dry heat sterilizers, ovens, fermentation equipment, freezers, filling equipment, HVAC/environmental control systems, incubators, environmentally controlled chambers, labelers, lyophilizers, freeze dryers, dryers, mixing tanks, neutralization systems, plant steam and condensate systems, process tanks, pressure tanks, vessels, refrigerators, separation/purification equipment, specialty gas systems, steam generators, pure steam systems, steam sterilizers, stopper washers, solvent recovery systems, tower water systems, waste inactivation systems, “

kill”

systems, vial inspection systems, vial washers, water for injection (WFI) systems, pure water systems, washers (glass, tank, carboys, etc.), single use bioreactors, and modular production devices.

9. ) A non-transitory computer readable medium having computer executable instructions to perform a method comprising,

a) initiating activation of a software based programmable logic controller, whereby the software based programmable logic controller comprises an embedded system, wherein said embedded system is integrated into a pharmaceutical manufacturing hardware device adapted for use in manufacturing a pharmaceutical;

b) compiling data generated during the pharmaceutical manufacturing, wherein the data relates to a pharmaceutical product specification;

c) transmitting the data over a distributed control system whereby the data is analyzed against the product specification;

d) taking corrective action on said pharmaceutical manufacturing process, where by the corrective action comprises stopping or modifying the pharmaceutical manufacturing process.

10. ) The pharmaceutical manufacturing process of claim 9, wherein the pharmaceutical manufacturing process produces an active ingredient.

11. ) The pharmaceutical manufacturing process of claim 9, wherein the pharmaceutical manufacturing process produces an inactive ingredient.

12. ) A manufacturing execution system (MES) comprising,

a) a non-transitory computer readable medium having computer executable instructions adapted for use to control a pharmaceutical or biopharmaceutical manufacturing device;

b) a software based programmable logic controller;

wherein the software based programmable logic controller is integrated into a pharmaceutical or biopharmaceutical manufacturing device;

c) a mobile wireless sensor network, whereby the mobile wireless sensor network is active for a pharmaceutical manufacturing or biopharmaceutical manufacturing environment.

13. ) The MES of claim 12, further comprising a wireless distributed system, whereby the wireless distributed system allows for pharmaceutical or biopharmaceutical production data to be assessed in a remote location.

14. ) The MES of claim 12, wherein the pharmaceutical or biopharmaceutical manufacturing device is selected from the group consisting of powder blending systems, granulation systems, crystallization systems, tablet presses, chromatography systems, pH systems, liquid mixing systems, water-based systems, finishing and packaging systems, cell culture systems, filtration/purification systems, centrifugation systems, vial inactivation systems, field instrumentation components and operational units, blenders, bioreactors, capping machines, separation systems, chilled water/circulating systems, glycol systems, modular coldrooms, clean steam systems, clean-in-place (CIP) devices, compressed air systems, D.I./R.O. water systems, dry heat sterilizers, ovens, fermentation equipment, freezers, filling equipment, HVAC/environmental control systems, incubators, environmentally controlled chambers, labelers, lyophilizers, freeze dryers, dryers, mixing tanks, neutralization systems, plant steam and condensate systems, process tanks, pressure tanks, vessels, refrigerators, separation/purification equipment, specialty gas systems, steam generators, pure steam systems, steam sterilizers, stopper washers, solvent recovery systems, tower water systems, waste inactivation systems, “

kill”

systems, vial inspection systems, vial washers, water for injection (WFI) systems, pure water systems, washers (glass, tank, carboys, etc.), single use bioreactors, and modular production devices.

15. ) The MES of claim 12, wherein the MES controls the pharmaceutical or biopharmaceutical manufacturing process in real-time, near real-time, or live.

16. ) The MES of claim 12, wherein the MES comprises a single layer architecture.

17. ) A method of monitoring quality control of a pharmaceutical or biopharmaceutical manufacturing process, said method comprising,

a) initiating activation of a software based programmable logic controller, whereby the software based programmable logic controller executes a non-transitory computer readable medium having computer executable instructions adapted for use to control a pharmaceutical or biopharmaceutical manufacturing device;

b) compiling data generated during the pharmaceutical manufacturing, wherein the data relates to a pharmaceutical product specification and wherein the data is stored in a remote storage database housed in a wireless distributed network whereby the data is maintained to create a historic record.

c) analyzing the data against the product specification;

d) taking corrective action on said pharmaceutical manufacturing process, where by the corrective action comprises stopping or modifying the pharmaceutical manufacturing process.

18. ) The method of claim 17, wherein the pharmaceutical manufacturing process comprises a tablet press process.

19. ) The method of claim 17, wherein the biopharmaceutical process comprises a cell culture process.

20. ) The methods of claim 17, wherein the monitoring is real-time, near real-time, or live.