Granted Patent B2

US 12,321,162 · App. 17/437,085 · Granted Jun 3, 2025

Inventors: Key Hyckenberg (Uppsala, SE); Magnus Karlsson (Uppsala, SE); Christoffer Hultqvist (Uppsala, SE); Henrik Lundkvist (Uppsala, SE)

Assignee: Cytiva Sweden AB

G05B23/0216G05B19/41835G05B19/41875G05B2219/31472

Abstract

Claims (50)

1. A method for monitoring a bio-pharmaceutical process, said bio-pharmaceutical process being controlled based on as set of instructions for controlling said biopharmaceutical process, the method comprising the following steps performed by a bio-pharmaceutical process monitoring element:

obtaining said set of instructions for controlling the biopharmaceutical process; and

while the instructions of the set of instructions for controlling the biopharmaceutical process are executed, for each executed instruction:

a) receiving an execution status update indicating which instruction is presently executed or has just been finished,

b) forming an execution status indication relating the instruction presently executed or just finished to its position in the set of instructions based on the received execution status update, and

c) displaying at least the set of instructions and the execution status indication for each instruction of the set of instructions;

wherein the set of instructions include a plurality of phases, each comprising a subset of the set of instructions,

wherein the execution status indication is displayed by marking the presently executed or just finished instruction in a display view, and

wherein also a next instruction for execution is indicated in the display view.

2. The method according to claim 1 , further comprising:

while a controller for controlling the bio-pharmaceutical process controls execution of the instructions of the set of instructions for controlling the biopharmaceutical process, for each executed instruction the controller transmits the execution status update to the bio-pharmaceutical process monitoring element.

3. The method according to claim 1 , further comprising:

obtaining at the biopharmaceutical process monitoring element sensor data related to the bio-pharmaceutical process; and

for at least a part of the instructions presently executed or just finished, correlating corresponding obtained sensor data with the execution status indication.

4. The method according to claim 1 , further comprising, for at least a part of the instructions presently executed or just finished, displaying the corresponding obtained sensor data.

5. The method according to claim 4 , wherein a next instruction for execution is also displayed.

6. The method according to claim 4 , wherein the set of instructions are displayed in the display view, said display view corresponding to the view used in programming.

7. The method according to claim 1 , further comprising, for at least a part of the instructions presently executed or just finished, storing the execution status indication and possibly the corresponding obtained sensor data, if the latter is present.

8. The method according to claim 1 , wherein the set of instructions for controlling the biopharmaceutical process comprises or is associated to at least one process variable value defining the biopharmaceutical process, said method comprises a step of:

obtaining, during execution of the set of instructions, at the biopharmaceutical process monitoring element an update of at least one of said process variable value defining the biopharmaceutical process; and

receiving, during the execution of the set of instructions, at a controller for control of the biopharmaceutical process information relating to the update for updated control of the biopharmaceutical process.

9. The method according to claim 8 , wherein the update of at least one of said process variable value is received via a user interface.

10. The method according to claim 8 , wherein the bio-pharmaceutical process monitoring element:

monitors the obtained sensor data related to the bio-pharmaceutical process;

detects when the obtained sensor data deviates from a predetermined pattern or value or boundary/boundaries; and

determines that at least one potential process variable value should be updated based on said detected deviation.

11. The method according to claim 10 , wherein control of the biopharmaceutical process is automatically updated based on the at least one potential process variable value or wherein the at least one potential process variable value is fed to a user interface for acceptance/rejection/amendment by the user.

12. The method according to claim 1 , wherein said bio-pharmaceutical process is a chromatographic process or method, and said instructions include chromatographic process or method steps, optionally comprising or including a recipe or recipe steps.

13. The method according to claim 12 , further comprising displaying on the display a currently running chromatographic process/method step or the recipe or recipe step, and in the same display view, displaying a predefined process/method step or the recipe or recipe step, corresponding to the currently running process/method step or the recipe or recipe step.

14. A system for monitoring a bio-pharmaceutical process, said system comprising:

a processing system comprising:

processing equipment wherein said bio-pharmaceutical process is performed; and

a controller arranged to store a set of instructions for controlling the biopharmaceutical process and executing the instructions of the set of instructions for generating control signals controlling the processing equipment,

wherein the controller is further is arranged to, for each executed instruction, generate and transmit an execution status update indicating which instruction is presently executed or has just been finished,

wherein the system further comprises a bio-pharmaceutical process monitoring element arranged to receive said execution status indication and to form an execution status indication relating the instruction presently executed or just finished to its position in the set of instructions based on the received execution status update,

wherein the system further comprises a display arranged to display at least the set of instructions and the execution status indication for each instruction of the set of instructions, wherein the set of instructions include a plurality of phases, each comprising a subset of the set of instructions,

wherein the execution status indication is displayed by marking the presently executed or just finished instruction in a display view, and

wherein also a next instruction for execution is indicated in the display view.

15. The system according to claim 14 , wherein the biopharmaceutical process monitoring element is arranged to store the set of instructions for controlling the biopharmaceutical process and wherein the forming of the execution status indication comprises to associate the received execution status update to a corresponding instruction in the stored set of instructions.

16. The system according to claim 14 , wherein the display is arranged to display the set of instructions in the display view, said display view corresponding to the view used in programming.

17. The system according to claim 14 , wherein the processing system further comprises a plurality of sensors arranged to monitor a status of the processing of the processing equipment and possibly the display is arranged to display the monitored status of the processing of the processing element.

18. The system according to claim 17 , wherein the biopharmaceutical process monitoring element is arranged to, for at least a part of the instructions presently executed or just finished, correlating corresponding obtained sensor data with the execution status indication.

19. The method according to claim 17 , further comprising a memory arranged to store the execution status indication and possibly the corresponding obtained sensor data, if the latter is present, for at least a part of the instructions presently executed or just finished.

20. The system according to claim 14 , wherein the set of instructions for controlling the biopharmaceutical process comprises or is associated to at least one process variable value defining the biopharmaceutical process.

21. The system according to claim 20 , wherein in response to obtaining of an instruction to update at least one process variable value during execution of the set of instructions, the biopharmaceutical process monitoring element is arranged to amend a display view based on the obtained process variable value update and to transmit the variable value update or information relating thereto to the controller, wherein the controller is arranged to generate control signals for controlling the processing equipment in accordance with the variable value update.

22. The system according to claim 21 , further comprising a user interface for user of the instruction to update at least one process variable value.

23. The system according to claim 21 , wherein the biopharmaceutical process monitoring element is arranged to

monitor the obtained sensor data related to the bio-pharmaceutical process,

detect when the obtained sensor data deviates from a predetermined pattern or value or boundary/boundaries and

determine that at least one potential process variable value should be updated.

Assignments (2)

Priority Claims (1)

Continuity (1)

References Cited (23)