iaiops-pharmav0.28.0

A pharma plant QA team uses cleanroom_pressure_cascade to verify that the EU GMP Annex 1 chain from grade A down to D holds door by door. Each cross-grade door is judged correct/insufficient/reversed/unknown and reported worst-first with the measured and required Pa values, while the door topology is declared by the operator rather than guessed.

An EMS engineer runs cleanroom_particle_check against the plant's own confirmed grade/state/size limit tables pulled from BACnet trend and point data. Readings below, above, or missing limits are separated so anything without a declared limit is counted as no_limit or not_graded rather than silently passing.

Utility engineers monitor PW and WFI loops via Modbus and HART-IP, applying pharma_water_check with the USP <645> stage-1 procedure. Uncompensated conductivity readings are compared to the table at the measured temperature, and out-of-stage-1 results are routed to Stage 2 wording instead of a failure verdict.

A manufacturing science team browses OPC-UA servers to read bioreactor, chromatography, and freeze-dryer tags plus alarms, then applies contextual baselines learned per declared recipe context. Readings in an unlearned context are labeled unknown_context instead of being silently compared to a global band.

Reliability and CSV teams use the cross-protocol brain to score data quality for flatlined electrodes, staleness, and out-of-range values without silent interpolation, and to attribute upstream downtime along a declared line sequence. Alarm event clustering groups the same condition written ten different ways into one bad actor by exact normalized text.

Annual subscription per manufacturing site that bundles the pharma edition protocol stack, the three Annex 1/USP semantic checks, and the cross-protocol diagnostic brain. Customers run it read-only against existing BACnet, Modbus, HART, and OPC-UA infrastructure and supply their own validated limits and door topology.

Professional services engagements that configure door topology, supply confirmed pharmacopoeia limit tables, and produce IQ/OQ documentation and audit-ready reports from the tool outputs. The read-only surface limits regulatory scope while the vendor's engineers help map the plant's declared relationships.

A hardware-plus-software offering that places an edge gateway reading BACnet/IP, Modbus, HART-IP port 5094, and OPC-UA at the plant floor and streams normalized data into the pharma edition server. Includes vendor register templates, alias maps, and offline advisory file mounting for device firmware checks.