DV-24081
Batch PX-2041
High Severity
AI agent active
Confidence
94%
Strong evidence94%
Excursion
38 min
Exceedance duration01:05 Peak
Peak Temp
10.4°C+2.4°C
Limit 8.0°CExceeded
Evidence
18 docs
5 Sources Sync82% Confidence
Progress
5 / 6
Checklist Done83%

Sensor temperature - overnight hold

Cold unit 3 · Batch PX-2041 · 14 Jun · 22:00-02:00 IST
10°
8°
6°
4°
VALIDATED MAX 8.0°C
Safe GxP Storage Zone (2.0°C - 8.0°C)
38 MIN ABOVE LIMIT
10.4°C · 01:05
22:0023:0000:0001:0002:00

Linked evidence

18 documents · 5 sources
DocumentSourceCapturedConfidence
MES_Bioreactor_4_Logs.csvMES Automation Skid B414 Jun 22:1596%
LIMS_pH_Verification.pdfQuality Control Lab #414 Jun 22:3094%
SOP-204-v5.pdfOperations Policy Vault25 May 202591%
DEV-2025-112.pdfHistorical Incidents Log14 Nov 202589%
AI Proposed Root Cause

A refrigeration valve failed to fully close during the overnight hold, allowing intermittent warm-air ingress. The resulting instability pushed Batch PX-2041 outside its validated range for ≈38 minutes, producing the specification deviation.

Strong
Evidence
Medium
Residual risk
94%
Confidence
Investigation Steps
Gathered manufacturing logs
Retrieved laboratory reports
Reviewed historical deviations
Compared SOP compliance
Proposed root cause
Waiting for investigator approval
Action Required: Timestamp Conflict

Maintenance records from 14 June contain conflicting timestamps that should be confirmed before sign-off.

Need clarification?