Sartorius Stedim Biotech Gmbh

Robert Soeldner

Jonas Austerjost

David James Pollard

A method for conducting a bioprocess with a digital control unit of a bioprocess arrangement, 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 bioprocess data are generated by the digital control unit, wherein a bioprocess control routine is executed by the local processor unit to control the bioprocess, wherein in the bioprocess control routine, the bioprocess data are generated by the digital control unit from actuator data and/or sensor data and/or user control command data. It is proposed that a signing routine is initiated by the local processor unit in the data safety routine to be executed by an external signing unit(s).

Method for conducting a bioprocess

Various embodiments relate to 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 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 generates bioprocess data from the actuator data and/or the sensor data and/or the user control command data. It is proposed that the digital control unit is configured to execute a signing routine via the local processor unit and that in the signing routine, the digital control unit digitally signs documentation data, derived from the bioprocess data, by generating a digital signature.

Digital control unit of a bioprocess arrangement

A method for conducting a bioprocess with a digital control unit of a bioprocess arrangement, wherein the digital control unit comprises a local data storage and a local processor unit, wherein bioprocess data are generated by the digital control unit. It is proposed, that in a data safety routine, a documentation routine and a signing routine are executed, that in the documentation routine, documentation data are generated from the bioprocess data and that in the signing routine, a cryptographic private key is extracted from private key data and the documentation data are digitally signed with the cryptographic private key by generating a digital signature and that the documentation routine is executed continuously during the bioprocess and that the signing routine is executed discontinuously during the bioprocess in several signing cycles according to a signing strategy, which defines trigger events for initiating the signing routine.

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Goettingen, Germany

Robert Soeldner