Calibration, Qualification & Predictive Maintenance
Every GxP-critical asset carries a qualification state (IQ/OQ/PQ), a calibration due date and a live health score — production cannot dispense or release against an unqualified or overdue instrument.
Asset & instrument register
| Asset | Location / line | Criticality | Qualification | Calibration due | Health | Status | |
|---|---|---|---|---|---|---|---|
EQ-1041 Fette 3090i Rotary Tablet Press | Line 3 — Tablets | High | Approved | 2026-09-04(17d) | Running | ||
EQ-1102 Glatt GPCG 300 Fluid Bed Dryer | Line 3 — Tablets | High | Approved | 2026-08-24(6d) | Running | ||
EQ-1188 IMA Comprima Capsule Filler | Line 2 — Capsules | High | Pending | 2026-08-21(3d) | Idle | ||
EQ-1240 Bosch Ampoule Filling Line | Line 5 — Sterile | High | Approved | 2026-10-12(55d) | Running | ||
EQ-1305 Autoclave 1200 L | Sterile Utilities | High | Overdue | 2026-08-12(-6d) | Under Maintenance | ||
EQ-1422 Purified Water Loop PW-01 | Utilities | High | Approved | 2026-09-30(43d) | Running | ||
EQ-1510 HVAC AHU-07 (Grade C) | Utilities | Medium | Approved | 2026-08-27(9d) | Running | ||
EQ-1633 HPLC Agilent 1260 #3 | QC Laboratory | Medium | Approved | 2026-08-20(2d) | Running | ||
EQ-1701 Blister Machine Uhlmann B1240 | Packaging Hall A | Medium | Approved | 2026-11-02(76d) | Running | ||
EQ-1808 Cold Room CR-02 (2–8 °C) | Warehouse | High | Approved | 2026-09-15(28d) | Running |
AI predictive maintenance alerts
- EQ-1041 · Tablet Press
Signal — Compression force variance +18% over 5 batches; upper punch wear pattern detected
Impact — Predicted weight-variation deviation within 9 production days · 3 batches at risk
Recommendation — Schedule punch set replacement in the 22 Aug changeover window
- EQ-1305 · Autoclave 1200 L
Signal — Sterilisation cycle F0 drift and calibration overdue by 6 days
Impact — Sterile batch release blocked — GxP qualification state is Overdue
Recommendation — Escalate to QA, quarantine affected loads and re-qualify (OQ/PQ) before next cycle
- EQ-1510 · AHU-07
Signal — Differential pressure trending toward Grade C lower limit during night shift
Impact — Environmental monitoring excursion risk in packaging corridor
Recommendation — Replace HEPA pre-filters and re-balance airflow this weekend
Records & transactions
Asset / equipment · Maintenance work order · Calibration record
No records posted in this module yet. Use “New record” to create one — it is saved to the shared database with an audit entry, recomputed into the KPIs and alarms, and fed to the AI agents as live context.