An overview of the Temperature Validation Study: What is it, and what are its implications?

temperature mapping validation

A temperature Validation study or temperature mapping validation is performed to examine the temperature condition inside an enclosed area, such as cold storage, warehouse, refrigerated vehicle, and others. It’s crucial for industries like food, FMCG, pharmaceutical, vaccines, etc., because it ensures that the products are inventoried in a controlled environment.

What are the factors a temperature Validation study checks?

The temperature mapping validation includes a series of examinations and analyses to ensure that a given facility is able to sustain the target temperature and humidity range. Once the validation process is done, the facility is certified by a third-party auditor based on the validation results.

The main parameters checked in temperature mapping validation are:

  • The temperature of the chamber or container used to store the samples.
  • The efficiency of the heating system/cooling unit.
  • Inspection of the thermometer and other equipment used to measure the temperature.
  • A thorough examination of whether the permitted range of temperature and humidity is maintained.
  • Whether the standard operating system according to a warehouse temperature mapping study is followed.
  • Whether the critical pieces of equipment have been installed and working as per the manual.
  • Whether the measures taken are adequate.
  • Records kept of all measurements made during the test period.

The implications of the temperature validation study

Warehouse temperature mapping will not only ensure that the products are safe to use but also helps to reduce wastage due to incorrect storage of goods.

As you can see from the list above, there are several areas of a storage facility that require constant monitoring. It will be more challenging to handle if they are not well-maintained.

For example, let’s say that the temperature of the room where the drugs are stored is too high. In the absence of optimal temperature, the medicine turns out to be ineffective. In the worst-case scenario, it could lead to the recalling of drugs by the company, costing the establishment a lot of money.

Here are some of the key implications of the temperature mapping validation study:

  1. The validation report can identify the presence of any hot spots inside the facility. It will also verify if the hotspot can be eliminated. If the problem seems permanent, then the area should be marked as unsuitable for storing temperature-sensitive goods.
  2. Warehouse temperature mapping will also check up to what time the products will be in perfect condition inside the storage facility in case of a power outage so that the business can take appropriate measures to ensure their product’s safety during a blackout.
  3. The report will mention the ideal spots to install sensors and other essential devices for continuous temperature and humidity monitoring.
  4. The warehouse temperature mapping report will also show the number of staff and equipment that can stay inside the room without affecting the desired thermal condition.
  5. The study will also check whether the facility can maintain ideal temperature conditions with the same efficiency, no matter whether it’s summer or winter outside.
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