Scope

ANSI/ISA-88 defines models and terminology for batch control: the physical model, the procedural control model and the state model of a procedural element. ISA-TR88.00.02 (PackML) applies the same approach to packaging and discrete machines and defines a state model with seventeen states and nine commands, and the unit modes Production, Maintenance and Manual. Both are referenced by the smart-state-machine component, which has the two state models built in, and by the batch screen.

The components display and check the state models; they do not execute them. The state of a machine or a unit is decided by its controller. The state machine component shows the model, marks the state the controller reports, offers the commands that are valid from that state, and raises a request event when the operator presses one. It never changes state on its own.

What is provided

  • The PackML state model, complete. The seventeen states (Stopped, Resetting, Idle, Starting, Execute, Completing, Complete, Stopping, Holding, Held, Unholding, Suspending, Suspended, Unsuspending, Aborting, Aborted, Clearing), the nine commands (Reset, Start, Stop, Hold, Unhold, Suspend, Unsuspend, Abort, Clear) and every automatic "state complete" transition are built in. canCommand(), target() and nextAutomatic() answer from the model, including its exceptions: Stop is not offered from Stopping, Stopped, Clearing, Aborting or Aborted, and Abort is offered from every state except Aborting and Aborted.
  • The ISA-88 procedural state model. Idle, Running, Complete, Stopped, Pausing, Paused, Holding, Held, Stopping, Aborting, Aborted and Restarting, with the commands Start, Stop, Hold, Restart, Abort, Reset, Pause and Resume.
  • Unit modes. The unit mode (mode) is shown next to the state. The modes offered (modes) are the application's list, for example Production, Maintenance and Manual, and a mode change raises modeRequest, a request like a command.
  • Custom models. A machine with its own model supplies its states, transitions and commands through the states and transitions properties and receives the same diagram, command bar and request events.
  • The batch screen. demos/industrial/batch/ shows an ISA-88 unit procedure: the procedural state machine, the recipe phases, the unit faceplates, a batch trend, a hash-chained batch record and release under an electronic signature.
  • Sequences. smart-sequence-editor runs an ordered list of steps with limits, raises stepStart for each step and records the result the application reports, which is the operator-facing part of a procedure or a test sequence.

Known limitations

  • No execution. The components do not run a procedure, sequence a phase or drive equipment. A command press is a request; the controller executes it and reports the resulting state.
  • No recipe management. ISA-88 recipe types (general, site, master, control), recipe procedures and formula management are functions of the batch management system. The batch screen shows a recipe's phases as data.
  • No PackML tag structure. The PackTags (Admin, Status, Command) defined by ISA-TR88.00.02 are not modelled. The application maps its tags to the component's state, mode and commandRequest.
  • No OEE calculation from PackML states. The state timeline shows the time in each state and the KPI wall screen shows OEE figures supplied by the application; the calculation is the application's.

Related: 21 CFR Part 11 and GAMP 5 for the batch record and its signatures.