This is a ready-to-use temperature mapping protocol for a controlled storage area. A space is not qualified because a wall thermometer reads in range; air stratifies, doors punch plumes, and racking tops behave nothing like the floor. Mapping finds the hot and cold spots so permanent monitors go where the risk actually is. Replace every <<FILL: ...>> placeholder, pre-approve the protocol before execution, and record results against the acceptance criteria. A filled specimen follows. Describe referenced standards by number and title; do not paste copyrighted clauses.
Approval page
| Role | Name | Signature | Date |
|---|---|---|---|
| Author | <<FILL>> | ||
| Reviewer (Quality) | <<FILL>> | ||
| Reviewer (Engineering / Facilities) | <<FILL>> | ||
| Approver (Quality Head) | <<FILL>> |
| Field | Entry |
|---|---|
| Protocol number | <<FILL: e.g. VP-MAP-018>> |
| Version | <<FILL>> |
| Area mapped | <<FILL: room / area ID>> |
| Labeled storage condition | <<FILL: e.g. 2-8 C>> |
1. Objective
To characterize the temperature distribution of <<FILL: area>> under normal operation and under defined stress, identify worst-case (hottest and coldest) locations, and justify the placement of permanent monitoring sensors on those locations.
2. Scope
This protocol covers <<FILL: area>> at <<FILL: site>>, labeled <<FILL: condition>>. It follows the qualification lifecycle of EU GMP Annex 15 and the storage-control expectations of the applicable GDP guideline and cGMP holding conditions (for the US, 21 CFR 211.142). It does not cover the routine monitoring system, governed by <<FILL: SOP-ID>>.
3. System description
<<FILL: description: dimensions, volume, racking layout, HVAC design, number of doors, heat sources, current setpoint, product stored>>.
4. Prerequisites
- Calibrated data loggers with current certificates traceable to a national standard, stated accuracy
<<FILL: e.g. +/-0.5 C>>. - Approved floor and elevation plan with numbered sensor locations.
- The area operating in its normal state (loaded to a representative level unless an empty study is justified).
- Loggers time-synchronized; recording interval set to
<<FILL: e.g. 1-5 min>>.
5. Roles
| Role | Responsibility |
|---|---|
| Author / executor | Deploys loggers, runs the study, analyzes data |
| Quality | Approves the protocol and report, dispositions failing locations |
| Facilities / Engineering | Supports HVAC configuration and stress challenges |
6. Sensor grid design
Design a three-dimensional grid weighted to the risk points: corners, geometric center, near each door, near HVAC supply and return, top and bottom of racking, and adjacent to any heat source. Justify the count against volume and the ICH Q9 risk assessment; there is no single mandated number.
| Location ID | Position | Rationale |
|---|---|---|
<<FILL>> | <<FILL: e.g. NE corner, top rack>> | <<FILL: e.g. suspected warm stagnation>> |
7. Duration and season
- Minimum
<<FILL: e.g. 7>>days of continuous logging, covering at least one full operational cycle. - Executed in the worst season (
<<FILL: summer / winter>>), or one season plus a documented worst-case rationale, because a space that holds in winter can fail in summer.
8. Stress challenges
- Open-door challenge: hold
<<FILL: door ID>>open for<<FILL: duration>>; record the excursion and recovery time. - Power-loss / HVAC-failure challenge: simulate loss for
<<FILL: duration>>; characterize how long the space stays in range and the recovery.
The recovery times define how long the space holds when something breaks, which feeds the excursion procedure.
9. Acceptance criteria
| # | Criterion |
|---|---|
| AC-1 | Every mapped location remains within <<FILL: labeled range>> throughout normal operation, with no single-point excursion. |
| AC-2 | No location breaches the cold limit (for a 2-8 C area, no reading at or below 0 C, since there is no freeze budget). |
| AC-3 | Post-study calibration verification confirms every logger remained within tolerance; any drifted logger’s data is rejected with rationale. |
| AC-4 | Open-door and power-loss recovery times are characterized and documented. |
| AC-5 | Worst-case locations are identified and a permanent-monitor placement rationale is written against them. |
10. Test cases
| TC | Step | Expected | Actual | Pass/Fail | Tester / date |
|---|---|---|---|---|---|
| TC-1 | Deploy and photograph all loggers per the grid | All locations placed and documented | <<FILL>> | <<FILL>> | <<FILL>> |
| TC-2 | Log continuously for the defined duration | Complete data set, no gaps | <<FILL>> | <<FILL>> | <<FILL>> |
| TC-3 | Compute min/max/mean/MKT per location | All locations within range (AC-1, AC-2) | <<FILL>> | <<FILL>> | <<FILL>> |
| TC-4 | Run open-door challenge | Excursion and recovery characterized (AC-4) | <<FILL>> | <<FILL>> | <<FILL>> |
| TC-5 | Run power-loss challenge | Hold time and recovery characterized (AC-4) | <<FILL>> | <<FILL>> | <<FILL>> |
| TC-6 | Verify post-study calibration | All loggers in tolerance (AC-3) | <<FILL>> | <<FILL>> | <<FILL>> |
| TC-7 | Define permanent-monitor placement | Monitors placed on worst-case locations (AC-5) | <<FILL>> | <<FILL>> | <<FILL>> |
11. Deviation handling
Any result outside acceptance is recorded as a protocol deviation, assessed for impact, and dispositioned by Quality before the report is approved. A chronic warm or cold location is resolved by fixing airflow and re-mapping the zone, or by prohibiting storage there and placing a permanent monitor as the worst-case witness.
12. Summary and conclusion
State whether each acceptance criterion was met, list deviations and their disposition, record the worst-case locations, and conclude whether the area is qualified for the labeled condition. Define the re-mapping triggers: a fixed interval (commonly every <<FILL: e.g. 3>> years) and on change (new racking, HVAC modification, layout or capacity change), routed through change control.
13. Attachments
- Floor and elevation plan with numbered locations
- Logger calibration certificates (pre and post)
- Raw data files and the per-location summary table
- Photographs of placements
Filled specimen
Illustrative summary table for a 2-8 C cold room, summer study. Numbers are examples.
| Location ID | Position | Min C | Max C | Mean C | MKT C | Verdict |
|---|---|---|---|---|---|---|
| CR-01 | NE corner, top rack | 3.1 | 7.9 | 5.4 | 5.6 | Pass |
| CR-07 | Adjacent to dock door | 3.4 | 8.6 | 6.1 | 6.4 | Fail (max > 8.0) |
| CR-12 | Near evaporator | 1.6 | 5.2 | 3.3 | 3.5 | Pass (no freeze) |
| CR-15 | Geometric center | 3.8 | 7.1 | 5.2 | 5.3 | Pass |
Disposition: CR-07 fails AC-1 at the dock door. Re-balance airflow and re-map that zone, or exclude the bay nearest the door from cold-chain storage and place a permanent monitor there as the worst-case witness. CR-12 passing the freeze check (AC-2) matters as much as the high end, since a 2-8 C product has no credit below 0 C. Open-door challenge recovered to under 8 C within 18 minutes; power-loss (HVAC off) held under 8 C for 42 minutes. Permanent monitors placed at CR-07 (or its replacement worst-case) and CR-12.
Common findings this protocol prevents
- Permanent monitors mounted at convenient eye level near a door while the true hot spot three meters away is unmonitored.
- Mapping done in one mild season with no worst-case rationale, so a summer failure is never seen.
- A drifted logger’s data used without post-study calibration verification.
- No open-door or power-loss characterization, so the excursion procedure has no basis for hold time.
- Mapping never repeated after a racking or HVAC change.
How to adapt this protocol
- Set the labeled condition and the sensor count justified against your volume and risk assessment.
- Decide the season strategy (both seasons, or one plus rationale).
- Feed the worst-case locations into your routine monitoring placement and your excursion procedure.
- Route the re-mapping triggers through change control for validated systems.
- Describe any referenced mapping guidance by number and title; do not paste copyrighted text.