Thermal Mapping and Cold Chain Validation
Every warehouse, chamber and cold room has a hot spot. We find it, prove it and document it — so your product stays potent, your batch stays releasable and your audit stays clean.
Any Controlled Space, Any Temperature
Warehouse & Store
Raw material, finished goods, dry and air-conditioned storage areas.
Cold Room & Chiller
+2 to +8 °C rooms for vaccines, APIs, biologicals and food.
Freezer & Deep Freezer
−20 °C and −80 °C units, sample and retention banks.
Stability Chamber
25/30/40 °C and RH chambers, BOD incubators and photostability units.
Autoclave & Sterilizer
Heat penetration with F0 calculation on the actual load.
Oven & DHS Tunnel
Depyrogenation FH, belt speed and loaded chamber studies.
Reefer Van & Vehicle
Distribution mapping loaded and unloaded, route qualification.
Shipper & Cool Box
Packing configuration and hold-time qualification for shipments.
How the Study Runs
| Protocol first | Sensor count and placement designed to WHO TRS 961 Annex 9 and ISPE guidance. |
| Calibrated sensors | Pre- and post-study calibration, traceable, certificates attached to the report. |
| 24 / 48 / 72 hours | Summer and winter seasonal studies, empty and loaded conditions. |
| Stress testing | Door-open excursion and power-failure recovery challenge. |
| Report & action | Hot and cold spot map, MKT, deviation analysis and corrective advice. |
Why clients call us before the audit
- Protect the batch. Catch a 3 °C excursion before it costs you a recall.
- Pass the inspection. Files formatted the way DGDA and GMP auditors expect.
- Prove it to buyers. Export customers get the cold chain evidence they demand.
- Place sensors correctly. We tell you exactly where the routine monitoring probes belong.
Frequently Asked Questions
How many sensors are needed for a thermal mapping study?
Sensor count and placement are defined in the protocol based on the volume and geometry of the space, following WHO TRS 961 Annex 9 and ISPE guidance. A small cold room may need 9 to 15 sensors; a large warehouse may need 40 or more.
How long does a mapping study run?
Typically 24, 48 or 72 continuous hours depending on the space and the regulatory requirement, with separate summer and winter studies for warehouses.
Do you include door-open and power-failure studies?
Yes. Standard stress tests include door-open excursions and a power-failure recovery study, so you know how long product stays within specification when something goes wrong.
What do we get at the end?
An approved protocol, the sensor layout drawing, full raw data with minimum, maximum, mean and MKT, a graphical hot-spot and cold-spot map, F0 or FH values where applicable, recommended fixed monitoring positions and a signed summary report.