Many industrial, laboratory and manufacturing processes deal with products that are
temperature-sensitive, such as foods or pharmaceuticals. For these processes, temperature mapping is a vital part of ensuring the temperature of the surroundings is being maintained within a certain range, in adherence with thermal compliance norms.
Apart from work-environments, temperature mapping is useful for ensuring temperature-controlled storage systems like cold storage units, warehouses, refrigerators and the like, are cooling the entire space effectively.
DEFINITION & IMPORTANCE OF
Temperature mapping is the process of mapping the frequency of temperature fluctuations, differences and the range of temperature within a controlled space,
over a period of time. It can locate areas where the maximum temperature fluctuations occur and analyze the source of the variations.
In a temperature-controlled environment, the temperature at different points can vary by up to 10°C. Typically, the central area maintains a nearly constant temperature, while areas surrounding the cooling fans, access points and the edges tend to fluctuate a lot. Another factor that influences the internal temperature is seasonal weather, especially in a warehouse.
Temperature in a particular space can be affected by a number of factors, which include:
The purpose of temperature mapping is to ascertain the variation of temperature, not just within a controlled system as a whole, but at different points within the enclosed space. A fluctuation of even a few degrees can have severe consequences for processes where temperature-control qualification is a critical aspect of maintaining quality.
Some of these processes include:
These products, and the systems they are processed within, require a strict control over the refrigeration and air-conditioning systems, to make sure the temperature is maintained within an acceptable range to prevent spoiling or contamination.
For perishable products such as medical supplies and pharmaceuticals, it is essential that the temperature and humidity of warehouses in which they are stored are attentively controlled. USP Good Storage and Shipping Practices, among other regulatory requirements, such as GMP and FDA, offer guidelines for the safe storage of such materials. Variations in humidity and temperature may have disastrous consequences if they cause things such as medicines to become ineffective, or alter the quality of sensitive products.
AKAT offers effective evaluation and validation of a warehouse's HVAC system to determine the design's suitability for the storage of materials with these requirements. The results are evaluated for approval of the space's intended use, and are also analyzed to document the warm and cold locations of each area for the effective placement of monitoring sensors to ensure continued compliance.
HOW IT WORKS
Typically, a temperature mapping exercise would run for 7 days in a large ambient or chilled storage facility.
When an Operation Qualification (OQ) map takes place, the chamber must be empty.
PQ tests are mapped when the chamber is full of product.
For most pharmaceutical and biotechnical applications, both an (OQ) and Performance Qualification (PQ) are equally important.
Our temperature mapping process follows a comprehensive and proven methodology, including:
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