Protocol · VAL-P02
Thermal Mapping Protocol - Vehicle and Cold-Chain Transport
Mapping of refrigerated vehicles and passive shippers across seasonal and route conditions.
Purpose
To define the method for mapping and qualifying the temperature performance of refrigerated or temperature-controlled vehicles and of passive shipping containers used for the distribution of time- and temperature-sensitive products, so that products remain within their labelled storage conditions throughout transport under the routes, durations, loads and seasonal conditions actually encountered.
What is inside
14 sections, about 3 pages when printed.
- 1. Purpose
- 2. Scope
- 3. Responsibilities
- 4. References
- 5. Definitions
- 6. Prerequisites
- 7. Acceptance criteria
- 8. Study design
- 9. Execution
- 10. Data analysis
- 11. Outcome
- Deviations
- Data integrity
- Report
How to complete it
- 1.Verify and configure loggers (VAL-F08); complete the placement register (VAL-F01) with photographs; record vehicle / shipper identity, set points, pack-out details and load.
- 2.Perform pull-down / pre-conditioning; record time to reach set point and ambient.
- 3.Perform the static loaded test; then the road test or chamber exposure per the plan, recording events.
- 4.Perform door-opening challenges at the planned points; record times.
- 5.Retrieve loggers, download raw data unaltered, post-verify loggers, complete VAL-F08.
- 6.Analyse per section 10; document deviations (VAL-F09).
Before you use it
- Replace every square-bracket token, starting with [LABORATORY NAME], [ADDRESS] and [EFFECTIVE DATE]. The full token list is in GD-01 Read Me First.
- Have the content technically reviewed against how your laboratory actually works, then approved by the responsible manager before it becomes a controlled document.
- Update the Word fields after editing so the table of contents and page numbers are correct: select all, then press F9.
- Record the document in your own document register and set its review date.
Related documents
- VAL-P01
Thermal Mapping Protocol - Warehouse and Cold Room
Temperature and humidity mapping of storage areas with acceptance criteria and sensor plan.
- VAL-P03
Thermal Mapping Protocol - Stability Chamber and Incubator
Empty and loaded mapping of chambers, incubators, fridges and freezers.
- VAL-P04
Environmental Monitoring System Validation Protocol
Validation of an EMS including sensors, alarms, data integrity and 21 CFR Part 11 / Annex 11 controls.
- VAL-P05
Installation Qualification Protocol Template
IQ template covering documentation, installation, utilities, calibration and safety checks.
- VAL-P06
Operational Qualification Protocol Template
OQ template covering functional tests, alarms, ranges, worst-case challenges.
- VAL-P07
Performance Qualification Protocol Template
PQ template covering loaded performance over extended duration under routine use.
- VAL-P08
Alarm and Excursion Management Procedure
Alarm configuration, response, excursion assessment, product impact and CAPA.
- VAL-P09
Sensor Placement and Mapping Study Design Procedure
Sensor count, grid design, worst-case locations, duration and seasonal considerations.