US 12,438,729 B2
Digital control unit of a bioprocess arrangement
Robert Soeldner, Goettingen (DE); Jonas Austerjost, Rietberg (DE); and David James Pollard, Bohemia, NY (US)
Assigned to Sartorius Stedim Biotech GmbH, Goettingen (DE)
Appl. No. 18/029,225
Filed by Sartorius Stedim Biotech GmbH, Goettingen (DE)
PCT Filed Sep. 16, 2021, PCT No. PCT/EP2021/075496
§ 371(c)(1), (2) Date Mar. 29, 2023,
PCT Pub. No. WO2022/069245, PCT Pub. Date Apr. 7, 2022.
Claims priority of application No. 20199395 (EP), filed on Sep. 30, 2020.
Prior Publication US 2023/0412391 A1, Dec. 21, 2023
This patent is subject to a terminal disclaimer.
Int. Cl. H04L 9/32 (2006.01); G06F 21/60 (2013.01); G16H 10/40 (2018.01); H04L 9/00 (2022.01)
CPC H04L 9/3247 (2013.01) [G06F 21/606 (2013.01); G16H 10/40 (2018.01); H04L 9/3239 (2013.01); H04L 9/50 (2022.05)] 20 Claims
OG exemplary drawing
 
1. A digital control unit of a bioprocess arrangement for controlling a bioprocess,
wherein the digital control unit comprises a local data storage and a local processor unit,
wherein the digital control unit comprises a bioprocess interface for sending and receiving bioprocess control data,
wherein the bioprocess interface comprises an actuator interface for sending actuator data to at least one actuator for influencing the bioprocess,
wherein the bioprocess interface comprises a sensor interface for receiving sensor data related to the bioprocess from at least one sensor,
wherein the digital control unit generates bioprocess data,
wherein the digital control unit comprises a user interface for displaying to a user at least part of the bioprocess data and for receiving user control command data,
wherein the digital control unit is configured to execute a bioprocess control routine via the local processor unit to control the bioprocess,
wherein in the bioprocess control routine, the digital control unit receives the sensor data from the sensor,
wherein in the bioprocess control routine, the digital control unit generates the actuator data based on the user control command data or the sensor data and controls the actuator by sending the actuator data to the actuator thereby influencing the bioprocess,
wherein in the bioprocess control routine, the digital control unit generates the bioprocess data from the actuator data or the sensor data or the user control command data,
wherein private key data are stored in the local data storage, that the digital control unit is configured to execute a data safety routine via the local processor unit, that the digital control unit is configured to execute a documentation routine via the local processor unit in the data safety routine, that in the documentation routine, the digital control unit generates documentation data from the bioprocess data,
that the digital control unit is configured to execute a signing routine via the local processor unit in the data safety routine and that in the signing routine, the digital control unit extracts a cryptographic private key from the private key data and digitally signs the documentation data with the cryptographic private key by generating a digital signature.