GMP Temperature and Humidity Mapping Services - UK & Ireland
Temperature, Humidity, and CO₂ Mapping Services.
Compliant with MHRA, HPRA, and FDA regulations.
Performed in accordance with WHO and ISPE Good Practice Guidelines.
Compliant GxP Thermal Mapping Solutions
Our skilled engineers use cutting-edge validation equipment to deliver accurate and reliable temperature mapping.
We prioritize quality and speed, ensuring your critical environments are optimized swiftly and to the highest standards.
We prioritize quality and speed, ensuring your critical environments are optimized swiftly and to the highest standards.
Warehouses and
Cold Stores
We temperature and humidity map rooms, labs, cold stores, freezer rooms, warehouses and blood banks of any size.
Laboratory
Equipment
We map controlled temperature chambers from -196 to 400°C including freezers, refrigerators, incubators and ovens.
Cryogenic
Storage
With full temperature mapping service we also validate Liquid Nitrogen storage Vessels, -150°C Cryo Freezers, and -80°C / -40°C Ultra Low Temperature Freezers.
Shipping
Studies
We provide Thermal Mapping vehicles, temperature controlled containers, temporary storage and shipping studies.
Stability Cabinet & Incubator
Humidity Mapping
We perform humidity mapping on warehouses, stability cabinets, and incubators in accordance with ICH guidelines.
Mapping is conducted using high-accuracy dataloggers, with optional bespoke pre- and post-calibration available via our Rotronic HygroGen humidity generator.
Temperature, Humidity and CO2 Mapping
Frequently asked questions
What is Temperature Mapping and why is it required?
Temperature Mapping is the process of using multiple
calibrated temperature sensors to record temperature across a defined space
such as cold rooms, warehouses, fridges, freezer or incubators for a defined duration.
Studies are performed under operational conditions and may include additional
studies including door open testing, power failure tests, empty / loaded
temperature distribution tests and temperature penetration tests. This ensures temperature
uniformity, identifies hot and cold spots and demonstrates the environment can
consistently maintain the required conditions.
Temperature mapping is a regulatory expectation by authorities including the MHRA, EMA, HPRA and FDA as part of GMP and GDP frameworks. It forms a core element of qualification and requalification activities. Without a compliant study, companies risk audit findings, product degradation and regulatory action. By performing mapping correctly, you provide objective evidence that your controlled environments protect product quality and patient safety.
Why choose Thermal Compliance for temperature mapping?
Since 2007, Thermal Compliance Ltd. has specialised in GxP compliant temperature and humidity mapping for the pharmaceutical, laboratory and biotech sectors. Our approach combines regulatory expertise, the right equipment and practical [problem solving to deliver audit-ready results.
What makes us different?
Temperature Mapping is not a simple pass/fail exercise, and not all failures mean equipment must be retired. In many cases, corrective actions or process adjustments can restore compliance and avoid costly replacement. If you are experiencing failure or have a complex mapping requirement, contact us we may be able to help protect your equipment.
What makes us different?
- Experienced Engineers - with over 15 years of GMP/GDP experience, not just technicians.
- The right Test Equipment - we operate a range of industry leading validation equipment (Ellab. Kaye. Vaisala, Rotronic etc.) to ensure the most suitable equipment for your application. Using the correct tools can make the difference between a successful and a failed study.
- Flexible protocols - we can execute your company protocols or generate bespoke documentation tailored to your process.
- Audit ready reporting- clear, compliant documentation designed to withstand regulatory inspection.
- Failure resolution - If issues arise, we work with you to identify the root causes and corrective actions, not simply report a failure.
Temperature Mapping is not a simple pass/fail exercise, and not all failures mean equipment must be retired. In many cases, corrective actions or process adjustments can restore compliance and avoid costly replacement. If you are experiencing failure or have a complex mapping requirement, contact us we may be able to help protect your equipment.
How often should temperature mapping be performed?
The frequency of temperature and humidity mapping depends on risk, regulatory expectation and your company's procedures. Unfortunately there is no single answer, but the following principles apply:
In practice, temperature mapping is normally performed during the Operational Qualification (OQ) phase and then requalified on a 1-3 year cycle, depending on the risk profile and regulatory expectations. For critical GMP storage, annual requalification is considered best practice.
- Company SOPs - If your SOPs define a mapping frequency, this must be followed. For critical equipment, many companies require annual mapping.
- Risk Assessment - The higher the criticality, the greater the frequency. Units storing high-value or temperature sensitive products are often mapped more often.
- Major Changes - Relocation, change of use, repairs or parameter adjustments may require repeat mapping.
In practice, temperature mapping is normally performed during the Operational Qualification (OQ) phase and then requalified on a 1-3 year cycle, depending on the risk profile and regulatory expectations. For critical GMP storage, annual requalification is considered best practice.
What dataloggers do Thermal Compliance use for Temperature and Humidity Mapping?
We operate several industry leading datalogging systems to suit different applications:
Temperature and Humidity Sensors are calibrated by Thermal Compliance Ltd and are traceable to national standards. This allows us to optimise calibration points for your specific process. The result is mapping data that is both accurate and audit ready.
- Ellab Tracksense Pro - wireless dataloggers for Temperature, Humidity, Pressure and CO2
- Kaye AVS and Validator 2000 - wired thermocouple based dataloggers
- Vaisala VL-2000-20R - temperature and humidity dataloggers
- Vaisala VL-1416-44V - temperature dataloggers
- Ebro EBI - temperature and pressure dataloggers
Temperature and Humidity Sensors are calibrated by Thermal Compliance Ltd and are traceable to national standards. This allows us to optimise calibration points for your specific process. The result is mapping data that is both accurate and audit ready.
How many sensors should be used in a temperature mapping study?
The purpose of temperature and humidity mapping is to identify worst case locations, the hottest and coldest locations within the useable space of the unit under test. To achieve this, the full space must be covered with additional probes are placed in high risk areas,
The number of sensors required required depends on:
Examples of sensor locations locations:
We recommend a physical inspection of the unit before every study to define the most appropriate sensor locations.
The number of sensors required required depends on:
- Size of the space (for example fridge or large warehouse)
- Useable space (shelves, racks, maximum and minimum storage height)
- Regulatory Expectations and SOPs (MHRA, FDA, EMA, HPRA)
- Potential high risk areas
Examples of sensor locations locations:
- Lowest and Highest storage locations
- Grid pattern covering useable space
- Near Sources of heating or cooling
- Doors and access points
- For warehouses consider windows, skylights, doors, vents, HVAC, lighting,
- Ambient temperature (external)
We recommend a physical inspection of the unit before every study to define the most appropriate sensor locations.
Our Validation Equipment
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