Requalification of two cold rooms at a pharmaceutical distributor
A pharmaceutical distributor in Germany was due to requalify two 2-8 °C cold rooms. The customer had the QA expertise and mapping experience in-house and was looking for one thing only: calibrated loggers. We supplied 30 temperature loggers with a valid calibration certificate and, once they were returned, handled the data readout and delivered the raw measurement files in CSV format.
The customer did everything themselves: protocol, placement, measurement period and assessment. Temperature Mapping Europe provided the calibrated equipment and the data readout. That is level 1: logger rental only.
This case has been anonymised. It describes how the project ran in practice, without sharing customer- or site-specific details.
How the project ran
Order and dispatch
30 calibrated loggers with a valid certificate, ready for use.
Carried out by the customer
The customer ran the entire study themselves: protocol, placement, measurement.
Data readout and delivery
A PDF readout per logger, plus all raw measurement data as CSV.
Once the return shipment arrived, all 30 loggers were read out. For each logger the customer received a PDF with summary statistics and the temperature profile, along with the complete raw measurement data as CSV files for their own analysis and for filing in their internal quality system.
Calibrated data, ready for in-house processing
At level 1, Temperature Mapping Europe supplies the equipment and the data. The customer works the results into their own protocol and report. That suits organisations with the QA expertise and capacity to handle it internally.
30 loggers with certificates
Each logger came with an individual calibration certificate traceable to national standards. The certificates form part of the mapping dossier.
PDF readout per logger
Per logger, an overview showing minimum, maximum and mean temperature, alarm status and the full temperature profile as a graph across the measurement period.
Raw data as CSV
All measured values as CSV files, ready to import into the customer's own analysis software, spreadsheets or quality management system.
When renting loggers only is the right call
This customer chose level 1 deliberately. They had QA staff with mapping experience and an existing protocol from earlier qualifications. The only thing missing was the hardware: enough calibrated loggers with valid certificates, available for a defined measurement window.
In that situation, an external protocol or report adds little. The customer knows their own rooms, the risk points and the acceptance criteria. What they need is reliable measurement data with traceable calibration.
- In-house QA department with mapping experience
- Existing protocol and acceptance criteria
- Calibrated equipment the only requirement
- Data readout and CSV for in-house processing
- No external reporting needed
Confirmation is a result too
All 30 loggers recorded values within the specified 2-8 °C limits. No excursions, no deviations. The measurement data was also used to redetermine the hot and cold spots in both cold rooms: they sat in the same places as at the previous qualification. It sounds like an unremarkable outcome, but it is exactly what a requalification should deliver: evidence that the temperature distribution established earlier still holds.
Hot and cold spots redetermined
The measurement data pinpointed the warmest and coldest zones in both cold rooms again. They matched the previous qualification, which kept the monitoring positions valid.
Requalification complete
The customer combined the data, certificates and their own assessment into a complete requalification dossier, ready for the next audit.
No external dependency
By renting only the loggers and handling the rest in-house, the customer kept full control over planning, execution and lead time.
Calibrated loggers, shipped across Europe
Have the QA expertise in-house and just need reliable, calibrated loggers? We ship calibrated temperature loggers to any location in Europe. You receive the data readout and raw CSV once they are returned.