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Temperature Mapping

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A temperature mapping study is an exercise to qualify temperatures (and humidity if required) of storage environments used for temperature sensitive products.  This can include but is not limited to Warehouses (Controlled, uncontrolled, Dedicated or Multi Market), Cold stores/Fridges, Freezers, Containers, Vehicles, Stability Chambers, Incubators, Labs………


The temperature mapping report will document any recorded Hot & Cold spots as well as recommendations for continuous monitoring positions where required.

Study results are presented as an independent document, designed to support your internal Standard Operating Procedures (SOP’s) and overall regulatory requirements.  Project scopes are tailored to meet individual requirements.

TEMPERATURE MAPPING FOR WAREHOUSES:

  • Empty & With load (product)
  • Summer & Winter
  • External ambient temperature (outside of facility)
  • Repeat projects every 2 to 3 years (or after any significant changes to structure or control systems)
  • Datestamp of any notable events (e.g. power failure)
  • Mapped during normal operations
  • Impact tests (e.g. HVAC power down, Door open tests)
  • MKT (Mean Kinetic Temperature)

    

TEMPERATURE MAPPING FOR COLD STORES, VEHICLES, CONTAINERS, CABINETS (FRIDGES, FREEZERS, STABILITY CHAMBERS, BLOOD BANKS):

  • Empty & With load (product)
  • Summer & Winter (if applicable)
  • External ambient temperature (outside of cabinet/cold store/vehicle)  
  • Repeat projects annually
  • Datestamp of any notable events (e.g. power failure)
  • Impact tests (e.g. door open)
  • Mapped during normal operations

 

Regulation:  Biomap has developed its tempertaure mapping services in consideration of regulatory guidelines from the IMB, MHRA, FDA and USP

Reports:  Our mapping reports include a detailed overview of the project results.  Attention is given to any reported excursions or notable events and recommendations can be provided for continuous monitoring locations.  Reports are provided in hard copy format but also include electronic data on CD format.

Data Acquisition:  Biomap utilises the Escort iMiniPlus range of electronic temperature data loggers (see temperature data loggers).

Benefits:

  • Site surveys
  • No impact on day to day operations
  • No strain on internal resource
  • Full report (Min, Max & Ave temperatures, MKT, Recorded Range, Schematics, Floor Plans, Certification, Recommendations for continuous monitoring, Hot and Cold spots, Summary and Events, Tabular data)
  • Cost effective, price incentives available for multiple projects or estimated forecast of requirements