Our Service

Isatec will execute the complete service for you. This includes:

  • A proposal based on a detailed discussion of your requirements
  • A bespoke protocol
  • Calibration and configuration of the loggers
  • Installation of the loggers prior to commencement of the mapping period.
  • Retrieval of the loggers following completion of the mapping period.
  • Downloading of the data and the production of a comprehensive report with recommendations.

What can be mapped?

Mapping requirements vary from business to business, but typical examples include:

  • Cold storage
  • Fridges/freezers (stand alone and walk-in)
  • Ambient warehouse storage
  • Pharmacies
  • Laboratories
  • Production areas
  • Blood banks
  • Server rooms
  • Production areas
  • Materials storage
  • Vehicles
  • Transport routes

What is a mapping report?

A mapping report is a detailed analysis of temperature ranges experienced within a defined area (usually a storage area, room or appliance) over a defined period of time. A mapping report includes:

  • Protocol
  • Acceptance criteria
  • Results (including temperature summary, hotspot/cold spot summary and graphical analysis)
  • Conclusions (including overall observations and recommendations)
  • Individual Log Tag reports
  • Log Tag calibration certificates

The report makes clear which sensors have been used in which locations – allowing you to make the safest and best use of your storage and working areas.

Using our knowledge of temperature monitoring, Isatec provides a complete, professional temperature and humidity mapping service for laboratories, pharmacies, warehouses, pharmaceutical storage areas and individual chiller units. Temperature mapping is also known as thermal mapping.

Predominantly in the pharmaceutical, bio-tech and healthcare environment it is critical that working/storage areas and chiller units are mapped to help ensure goods are being kept safe and away from any ‘hot/cold spots’ within your facilities.

Mapping can be required to give evidence of extreme seasonal temperature (and/or humidity) variations in ambient areas (winter/summer mappings) and also prior to the commissioning (or re-commissioning) of a facility. Typically, the mapping period for large ambient/chilled working/storage areas is 7 days and for smaller chiller units, 48/72 hours is sufficient.

The MHRA, FDA and other agencies can make temperature and humidity mapping a requirement for licencing:

“…with rare exception, all warehouses and refrigerators should be temperature mapped prior to use to ascertain the temperature distribution within the area used for handling medicines. The mapping exercise should be repeated where conditions significantly vary, such as with seasonal variation, alteration in storage layout and changes in supply of supplemental heating and cooling.”

…..”A mapping exercise should consist of a description of the mapping method (protocol), including equipment used, placement of probes, responsibilities, types of information to be recorded and method and responsibility for analysing the data.”

…..”Mapping should be traceable to the individual and equipment taking the record and be traceable to temperature recorder calibration status.”

Source: Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2014

Compiled by the Inspection, Enforcement and Standards Division of the Medicines and Healthcare Products Regulatory Agency (MHRA)