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Temperature Mapping / Relative Humidity Mapping

According to SFDA requirement for pharmaceutical stores, temperature mapping for storage area, cold room and vehicle must be done at least once in winter and once in Summer. In addition, this was not only required by SFDA but most of international Authorities mentioned that in their regulation e.g. EU, MHRA, USFDA and WHO.

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  • Warehouses.
  • Cold Room.
  • Transportation vehicle
  • Fridge’ss / Freezer’s/Deep Freezer’s
  • Incubators.
  • Stability chambers
  • Ovens
  • Cold chain shippers, packing qualification and testing
  • Thermal Mapping of Steam staralizer (Autoclve) dy Heat Oven, (Heat distribution Studies, and Heat Penetration Studies) by using thermal validator.

The temperature mapping exercise is expected to collect the following information:

  • The impact of interventions (door openings / power failures, etc.)
  • dentification of hot and cold spot
  • Variation of temperature at a single point
  • Temperature variation across the area
  • Length of time of any temperature excursions.

Temperature mapping and equipment qualification are mandatory for other industries For example:

Healthcare

where blood bags and medicines are stored and incubators, freezers and refrigerators (WHO Guideline for blood establishment)

Food

Storage areas, cold rooms, freezers and vehicles ( ATP Agreement)

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