Monitoring for Regulatory Compliance & Product Safety
Temperature - Humidity - Moisture - Pressure - pH
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What is Temperature Mapping?

A temperature mapping study is performed to generate a temperature profile of your facility to ensure that the facility is capable of maintaining the required product storage temperatures and to determine the placement of the continuous monitoring sensors.

Why is Temperature Mapping required?

The references from regulatory authorities quoted below underline the importance of the storage and transportation temperature in maintaining product quality of medicinal products in the distribution network. Temperature mapping is required to assess the ability of your facility to maintain the required temperature range.

‘’For many medicinal products, storage and transportation temperatures are a highly significant factor in maintaining the quality of medicinal products throughout the distribution network’’ (HPRA Guide to Control and Monitoring of Storage and Transportation Temperature Conditions for Medicinal Products and Active Substances). You can read the regulatory guidelines for this sector here.

 ‘’Medicinal products should be transported in such a way that they are not subjected to unacceptable degrees of heat and cold’’ (Recommendations on the control and monitoring of storage and transportation temperatures of medicinal products, John Taylor CChem, FRSC, MHRA Inspector)You can read the regulatory guidelines for this sector here.

‘’32% of all critical and major deficiencies recorded by MHRA’s GDP inspectors during 2005/2006 related to the control and monitoring of storage and transportation temperatures’’ (Cold Chain Distribution for Pharmaceuticals, Cheryl Blake January 2008)

What is involved in a Temperature Mapping Study?

Following initial contact Rototherm will arrange a site visit to perform a site survey and risk assessment. This provides the necessary data for the production of a quotation for the work.

On receipt of your instructions to perform the temperature mapping study the process is as follows:

  • Rototherm prepare a project plan for the temperature mapping and timelines are agreed
  • Rototherm prepare the Protocol for the Temperature Mapping which is agreed and signed off by both companies prior to the start of the mapping study
  • Temperature Data Loggers are placed in your facility in accordance with the Protocol by Rototherm trained Technicians with height assistance provided by you. These data loggers are left in place for the duration of the mapping study
  • At the end of the mapping study Rototherm Technicians retrieve the data loggers which are brought back to Rototherm for data download, analysis and report creation.
  • The Mapping Report, when finalised to the agreed timelines, is reviewed with the customer to ensure understanding of the process and the report including all recommendations.