AI Generated Draft

Root Cause Analysis (RCA) Deviation - Bioreactor BRX-500

Data Provenance SCADA Telemetry 2026-04-20
Multi-Agent Consensus Verified (2 Agents) ✓
Governance State Pending Human Validation

1.0 Equipment Information

Bioreactor BRX-500 (Serial: 88-X2-110). Last calibrated on 12-Jan-2026. Routine check indicated normal operational parameters prior to Deviation #409.

2.0 Deviation Description

During the expansion phase (Day 14), temperature probe T-02 registered a sudden spike exceeding the defined upper limit. Reading of 39.2°C was recorded while redundant probes remained stable at 37.0°C.

3.0 Formulated Root Cause

The deviation is attributed to an isolated sensor malfunction (T-02 drift) rather than a true biological temperature excursion. Cell viability remains uncompromised.