7.1.6.1 Overview

The RunningStateMachineType is a sub-state machine of the FunctionalStateMachine and includes detailed substates. It is formally defined in Table 32.

The Running StateMachine is depicted in Figure 17.

Complete: Complete indicates that the process associated with the active protocol has come to its defined end. The unit/device will wait in this state until a Reset command is issued (in which case it will transition to Resetting), or until the unit/device is Stopped or Aborted.

Completing: Once the process associated with the current mode has reached a defined threshold (e.g., the required number of samples for the current job have been analysed or the cultivation/fermentation process has reached is final stage in terms of cell count, product yield, cell viability, etc.), the unit/device transitions from Execute to Completing. All steps necessary to shut down the current process are carried out in this state. The unit/device then transitions automatically to the Complete state.

Execute: The unit/device is actively carrying out the behaviour or activity defined by the selected protocol and its associated processing mode. Examples of a unit/device in processing mode include when the unit/device is performing an analytical run, cultivation/fermentation in the case of a bioreactor, or another defined unit of operation provided by the instrument (e.g., separation in the case of a centrifuge).

Held: The unit/device is paused, waiting for internal process conditions to clear. In this state, the unit/device shall not continue processing, although it may dry cycle if required (e.g., maintaining process conditions critical for the preservation of the samples or culture). A transition to Unholding will occur once internal unit/device conditions have cleared, or if the Unhold command is initiated by an operator.

Holding: The unit/device will transition from Execute to Holding if conditions internal to the unit/device require a pause in processing. Examples of such conditions include low levels of materials required for processing (e.g., consumables, reagents, buffers, etc.) or other minor issues requiring operator service. After all steps required to hold the unit/device have been completed, the unit/device will transition automatically to the Held state.

Idle: The unit/device is in an error-free state, waiting to start. The unit/device transitions automatically to Idle after all steps necessary for Resetting have been completed. All conditions achieved during Resetting are maintained. A Start command will transition the unit/device from Idle to Starting.

Resetting: In response to a Reset command, the unit/device will transition to Resetting from either Stopped or Complete. In this state the unit/device attempts to clear any standing errors or stop causes. If successful, the unit/device transitions to Idle. No hazardous motion should occur while in this state.

Starting: The unit/device completes all steps necessary to begin execution of the active protocol. Typical steps during this state include but are not limited to inspecting system setup (checking sufficient supplies of resources and consumables), priming of fluids, homing of handling systems, or equilibration of process conditions. A Start command will cause the unit/device to transition from Idle to Starting. The unit/device will transition automatically from Starting to Execute once all required steps have been completed.

Suspended: The unit/device is paused, waiting for external process conditions to clear. In this state, the unit/device shall not continue processing, but may dry cycle if required (e.g., maintaining process conditions critical for the preservation of the samples or culture, including but not limited to temperature, oxygen or pH levels, etc.). Once external conditions have returned to normal, the unit/device will transition to Unsuspending, with or without operator intervention.

Suspending: The unit/device will transition from Execute to Suspending if conditions external to the unit/device require a pause in processing. Such conditions include faults to upstream or downstream equipment. The decision to Suspend may be made by a human operator supervising the process, an automated supervisory system monitoring the conditions of the overall process line/workflow, or by unit/device Sensors detecting downstream blockages or upstream scarcity of samples, etc. (In the former case, the unit/device is 'blocked"; in the latter case, the unit/device is "starved".) After all steps required to suspend the unit/device have been completed, the unit/device will automatically transition to the Suspended state.

Unholding: After all internal process conditions that caused the unit/device to hold have cleared, the unit/device completes all steps required to resume execution of the active protocol. Once all required actions to unhold the unit/device have been completed, the unit/device will transition automatically to the Execute state.

Unsuspending: After all external process conditions that caused the unit/device to suspend have cleared, the unit/device completes all steps required to resume execution of the active protocol.

The children of the RunningStateMachineType have additional References, which are defined in Table 33.

The Component Variables of the RunningStateMachineType have additional Attributes, as defined in Table 34.