Pharma Validated Batch Record
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Briefing
Commission a validated pharmaceutical batch reactor. A batch can start only after the recipe, vessel-clean status, door interlock and operator sign-off are confirmed. Heat and agitate until the process model qualifies the temperature hold, require sign-off before discharge, and issue RECORD_COMPLETE only after the vessel is drained. Losing a critical interlock during execution must stop the batch and latch a deviation — the audit events in the model preserve the significant transitions.
Objectives
- Prevent batch start unless recipe, clean-status, door and operator checks are all confirmed
- Heat and agitate only while a qualified batch is active and the hold is incomplete
- Require both HOLD_COMPLETE and OPERATOR_SIGNOFF before opening discharge
- Latch DEVIATION_ALARM when a critical interlock is lost during a running batch
- Set RECORD_COMPLETE only after the signed-off batch has physically drained
Hints
- Latch an internal BATCH_BIT from a fully qualified START rung rather than driving outputs directly from START_PB
- The physics publishes TEMP_IN_RANGE, HOLD_COMPLETE and BATCH_DRAINED; your program owns the permissives and record state
- A deviation is retentive: SET it on BATCH_BIT AND NOT CRITICAL_INTERLOCKS_OK, then clear it only with STOP and restored interlocks
I/O Table
Inputs
START_PBStart batch request
BOOL · %I0.0
STOP_PBStop / deviation reset
BOOL · %I0.1
RECIPE_VERIFIEDApproved recipe checksum matches
BOOL · %I0.2
EQUIPMENT_CLEANValidated clean-status released
BOOL · %I0.3
DOOR_CLOSEDReactor access door interlock
BOOL · %I0.4
OPERATOR_SIGNOFFAuthenticated operator sign-off
BOOL · %I0.5
TEMP_IN_RANGEPhysics: validated temperature band
BOOL · %I0.6
HOLD_COMPLETEPhysics: qualified hold duration complete
BOOL · %I0.7
BATCH_DRAINEDPhysics: vessel drained below 5%
BOOL · %I1.0
CRITICAL_INTERLOCKS_OKPhysics: recipe, clean and door chain healthy
BOOL · %I1.1
Outputs
BATCH_ACTIVEValidated batch execution active
BOOL · %Q0.0
AGITATORReactor agitator
BOOL · %Q0.1
HEATER_ENABLEJacket heater enable
BOOL · %Q0.2
DISCHARGE_VALVESigned-off batch discharge valve
BOOL · %Q0.3
DEVIATION_ALARMLatched GMP deviation
BOOL · %Q0.4
RECORD_COMPLETEElectronic batch-record completion flag
BOOL · %Q0.5
Your program will be tested against:
All test cases run automatically when you submit. Assertions are hidden until you pass.
- #1Unqualified batch start is denied
Missing recipe approval must keep every process output off
- #2Qualified batch starts
All release checks allow heating and agitation
- #3Qualified hold, sign-off and drain complete the record
The process hold qualifies before discharge and record completion
- #4Critical interlock loss latches a deviation
Opening the door during a batch stops the process and latches the deviation
Related scenarios
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