Get a free initial 3D mapping plan, rent data loggers or let us carry out your full temperature mapping, including GDP/GxP-compliant reporting. Practical, well documented and without a lengthy consultancy project.
We prepare the protocol, you carry out the measurement, and we process the data into an audit-ready report with a conclusion and hot- and cold-spot identification.
We prepare the protocol, perform the measurement on site and process the data into an audit-ready report with a conclusion and hot- and cold-spot identification.
"Placing the loggers ourselves and still receiving a fully substantiated dossier was exactly what we needed."
Operations manager, pharmaceutical distribution
The customer’s team placed the rented data loggers on site. We provided a robust protocol, risk analysis, 3D visuals, measurement strategy, data analysis and an audit-ready final report.
Situation
Relatively small API storage area under GDP with temperature-sensitive products (15-25 °C), where planning and practical execution needed to stay simple. Pragmatic and compliant.
Approach
Hybrid strategy. A protocol with measurement points and measurement duration was defined up front. The customer’s team placed the rented data loggers on site according to the instructions and returned them afterwards. One week later, the customer had a fully audit-ready report.
Result
A substantiated dossier with raw data, analysis, conclusion and advice for routine monitoring.
Carried out with expertise from pharma and distribution
At Temperaturemapping Europe, your project is handled by people with real industry experience. Our approach is technically sound, but above all focused on what is needed in practice to assess and substantiate storage conditions properly.
EU-GMP/GDP practice experience
One of our team members is Jur. He is a QA manager and Responsible Person / Designated Person in an EU-GMP/GDP environment for pharmaceutical raw materials. In that role, he is involved daily in validation and qualification programmes in a strictly regulated environment.
Practical and risk-based
The people assessing your space come from industry. They understand both the guidance and how temperature mapping is assessed in practice by QA, auditors and inspectors.
Vendor-neutral
Temperature Mapping Europe is an independent company, not a manufacturer, distributor or label of any equipment supplier. We sell no monitoring systems of our own and choose data loggers on a brand-neutral basis. Our approach follows ISPE, WHO, GDP, GMP and HACCP guidance, independent of any supplier.
Personal approach
The same person helps define the measurement setup, assesses the space, processes the data and writes the report. That gives you short lines, fast planning and one fixed point of contact.
For fridges, freezers and compact spaces usually 24 to 72 hours (ISPE: at least 24 hours). For warehouses, EU GDP requires measurement under representative conditions; as guidance, national authorities such as the Dutch IGJ suggest 7 consecutive days including a weekend, with a minimum of 48 hours during which a variable occurs twice. The initial mapping is done while the space is still empty; a measurement under load may also be needed.
How many measurement points are needed?
It depends on the volume of the space and the applicable guideline. As a rule of thumb, smaller volumes (up to roughly 2 m³) are measured at about 9 points and larger volumes at 15 or more, in line with the ISPE guidance. The exact grid is defined in the protocol.
Can we carry it out ourselves?
Yes. You can rent a set of calibrated data loggers for your own mapping, requalification or temperature study, including calibration certificates and instructions. Help with read-out, analysis or the full dossier is available as an option. See data logger rental →
How much does temperature mapping cost?
Data logger rental starts at €299 excl. VAT for 10 loggers. A mapping and qualification report starts at €599 excl. VAT on top of data logger rental. A full on-site execution starts at €999 excl. VAT on top of data logger rental and any travel expenses. The exact price depends on the volume, the number of measurement points, the duration, the location and any additional test scenarios.
When can the loggers, protocol and report be ready?
When the planning and input are complete, loggers can usually be shipped within 1-2 working days. A protocol with measurement-point plan is typically delivered within 2-3 working days. After receiving the measurement data, the qualification dossier usually follows within 5-7 working days.
Tell us briefly what you need to measure. We will advise you on measurement duration, logger count and the most suitable route: self-measurement, logger rental or full execution.
GMP/GDP
WHO
