Articles

Temperature Mapping Validation Essential Part Of Phrma & Healthcare Industry

by Falak Noori Cold Chain Services for Food

In the healthcare and the pharmaceutical industries temperature mapping is one of the significant activities for the Autoclaves. ETO chambers, dry heat sterilizers, incubators, stability chambers ad holding areas like warehouses.

A good quality, temperature mapping machine plays an essential role in ensuring the reliable results, mainly in the food and pharmaceutical production industries. The real purpose of the temperature mapping validation is to make sure that all the areas of the storage or process equipment possess the required or much needed temperature to maintain the quality of the product. The temperature map ultimately helps in understanding the distribution of temperature in entire storage area. It also considers the humidity density and temperature of the storage to store the environmentally sensitive goods.

Working of the temperature mapping device:

1. It helps in creating the validation protocol and plan with scientific and logical justification for each.

2. The temperature mapping validation process identifies the areas of the risk and then produces protocol data to determine the exact place to fix the sensors to eliminate any sort of risk to the products from getting affected.

3. It helps in selecting the correct technology for the job to be done.

4. Helps in setting up the mapping devices and perform the tests in some extreme conditions.

5. It also helps in preparing the complete report describing summarize and findings of the test for the further action to be taken.

Some common issues:

How does the properly designed temperature mapping validation service works or what are the compliance and validation services provided by the temperature mapping device? For the warehouses, storage area or refrigeration tool, temperature mapping can help in determining the following:

Any sort of fluctuation or change in temperature: regular alteration in temperature at any particular area can be the reason of direct exposure to the internal cooling source or outside air systems.

- Lighting

- Doors left open

- Open doors of dock in the transit area

- Non-conditioned to hallways areas

- Air vents from the HVAC systems

Cold and hot spots: Cold and hot spots are basically caused due to three factors.

Inability to maintain the target storage temperature. If the temperature of entire warehouse cannot be maintained, the expert evaluation of HVAC system is in order.

- Shelving or walls that block the flow of air

- Insufficient size of fan to circulate air properly

- Air flowing from the HVAC system


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About Falak Noori Junior   Cold Chain Services for Food

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Joined APSense since, July 6th, 2015, From Riyadh, Saudi Arabia.

Created on Dec 31st 1969 18:00. Viewed 0 times.

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