Batch BT-020933
Celdurin IV • PPL • L034 • completed
About this view
This batch detail page ties execution evidence, material genealogy, equipment fitness, in-process controls, and quality events into one release-focused view. Users can trace each unit operation against timestamps and investigate linked exceptions without leaving context. The panelized layout supports QA review by exception while preserving full evidence access. Next actions include closing residual issues and completing disposition-ready evidence checks.
Planned
2026-05-16 → 2026-05-25
Actual
2024-04-11 → 2025-10-16
Exceptions
4
Release Risk
medium
Step Timeline
| Step | Status | Start | End | Result |
|---|
Materials Consumed and Genealogy
| Lot | Material | Status | Genealogy |
|---|---|---|---|
| LOT-012598 | Histidine Buffer Variant 6 | expired | Open workbench |
| LOT-012599 | Sodium Chloride Variant 6 | consumed | Open workbench |
| LOT-012600 | Water for Injection Variant 6 | in-process | Open workbench |
| LOT-012601 | Purified Water Variant 6 | approved | Open workbench |
| LOT-012602 | Ethanol 95% Variant 6 | approved | Open workbench |
| LOT-012603 | Isopropyl Alcohol Variant 6 | approved | Open workbench |
Equipment and Calibration
| Asset | Status | Calibration Due | Qualification |
|---|---|---|---|
| AST-01264 Compressed Air System #265 | out-of-service | 2025-03-24 | not-qualified |
| AST-01265 HVAC Unit #266 | cleaning-required | 2024-12-12 | qualified |
| AST-01266 Refrigerator #267 | operational | 2025-01-08 | qualified |
| AST-01267 Freezer Ultra-Low #268 | operational | 2026-04-07 | qualified |
| AST-01268 Incubator #269 | operational | 2025-03-08 | requalification-due |
| AST-01269 Autoclave Sterilizer #270 | in-calibration | 2025-12-25 | not-qualified |
| AST-01270 Conveyor Belt #271 | in-maintenance | 2026-08-30 | qualified |
| AST-01271 Labeling Machine #272 | out-of-service | 2025-08-17 | qualified |
In-Process Controls and Pending Tests
| Control | Measured | Spec | Status |
|---|
Exceptions and Deviations
| Exception | Severity | Status | Deviation |
|---|---|---|---|
| Environmental Excursion | major | closed | Not linked |
| Environmental Excursion | major | closed | Not linked |
| Environmental Excursion | major | closed | dev-01434 |
| Environmental Excursion | major | closed | Not linked |
| Environmental Excursion | major | closed | Not linked |
| Environmental Excursion | major | closed | Not linked |
QA Review Checklist and Signatures
- Step execution completeness verified with signed evidence.
- All high-severity exceptions dispositioned or justified.
- QC release tests reviewed and OOS investigations closed or dispositioned.
- Final release signatory validated with segregation-of-duties check.
No release readiness record found.