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GUIDELINES FOR TEMPERATURE MAPPING AND VALIDATION STUDY

Temperature Mapping And Validation Study- Guidelines

Cold chain logistics requires strict adherence to temperature requirements. Thermal mapping and qualification studies can help organisations assess if their warehouses, cold rooms, transport vehicles, or refrigerators are maintaining the correct temperature. Continuous maintenance of the recommended temperatures is crucial for preserving the quality of food and pharmaceutical products. Hence, companies in the medical and FMCG industries conduct regular mapping studies to validate the performance of their cold chain logistics. Let’s understand the critical guidelines that govern these inspections.

Temperature Mapping Validation: A Quick Introduction

Temperature mapping assessments provide reports on temperature distributions within a storage area. Temperature mapping validation goes a step further. It evaluates temperature distributions along with many other criteria like the appropriateness of installations and SOP checks. This qualification process answers the following questions in addition to conducting temperature checks:

  • Are the installations correct?
  • Does the facility have written Standard Operating Procedures (SoPs)?
  • Are the SoPs sufficient to meet regulatory requirements and best practices?
  • Are the machines functioning as intended?

The thermal mapping and validation study ensures the effective operations of temperature-controlled logistics.

Temperature Mapping and Qualification Process: Critical Guidelines

The validation process requires precision to extract appropriate insights from the study. The validation process must meet the stipulations of “21 CFR Part 11”. If a facility fulfils these requirements, it can get an internationally recognised certification. The following guidelines apply to the assessment:

  • Empty Condition: The evaluators must test the temperatures when the facility has no present load.
  • Partially Loaded Condition: The assessors must check the temperatures when the facility carries 60% of its permissible load.
  • Completely Loaded Condition: The temperature checks must happen for the third time when the facility carries 100% of its total capacity.
  • Door Opening Test: The evaluators open and close the facility’s doors to check how this change affects the internal temperature. A recovery test is also essential to check how soon the temperature reverts to its original level after closing the door.
  • Power Failure Test: The assessors trigger a power failure and record its effects to understand how the facility responds in this situation.
  • Start-up Test: The inspectors also monitor the time it takes for the facility’s temperature to stabilise, especially in the case of vehicles like refrigerated trucks.
  • Hot and Cold Spots: The surveyors must identify the hottest and coldest spots inside the facility during the temperature mapping validation study.

In addition to these steps, the assessors must inspect the effective functioning of the temperature systems. They can provide a certification based on the pass or fail status of the inspected facility.

FAQs

#1 What are the acceptance criteria in a thermal mapping validation study?

The assessors define the criteria before the tests start. Usually, the temperature must remain in the 2-8 degrees Celsius range during the testing period except half an hour after the door opening test.

#2 How can you test the temperature of an existing warehouse with loaded goods?

The testing of such warehouses takes place for one to two weeks. The empty warehouse testing can happen during holidays.

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