One of the critical factors in ensuring and determining product quality and safety is temperature control in the area of operation or where a product is stored, because, chemical substances (from which pharma product is made), sensitivity to temperatures and efficacy, quality, and safety are directly linked to the temperature values.
Due to these reasons and many more, a temperature control function is installed at various critical locations to ensure it does not drift from the acceptable limits.
However, in some instances, temperatures drift out of range mainly due to a fault in the control system or human error, making temperature control ineffective and degrading the product in the relevant area.
Temperature mapping is implemented in critical areas to prevent damage to the product, especially in storage, and to detect deviations from acceptable temperature ranges. During accreditation, it also serves as a compliance requirement in the pharma industry (for storage areas).
Other than those mentioned above, some other reasons cause temperature defection in the area, which we will discuss later in this article.
Temperature mapping in the pharmaceutical industry is mainly required for storage areas, which is also the main subject of this article.
What is temperature mapping?
Temperature mapping involves placing several temperature sensors across an area to determine the exact values at specific points. Measuring temperature values in different regions and correlating them with each other creates a map of temperature distribution, which can be used to analyze the behavior of temperature in various sections of area of determine its impact, specifically hot or cold areas.
Temperature mapping is obtaining the temperature profile of an entire area and observing how it changes across different sections of an area. Its primary purpose is identifying and detecting anomalies and determining how temperature deviates. It also helps to decide what objects are causing deviation in a particular area.
Mapping is mainly performed for all critical points, which depends on the area's physical structure, product placement, and the effect of external temperature values.
Temperature mapping in the pharmaceutical industry is mainly used to assess the temperature profile of storage areas, cold rooms, and refrigerators, where temperature-sensitive products are kept.
Why temperature mapping?
Let's discuss some whys of temperature mapping in pharmaceutical industry
Seasonal changes affect the overall temperature of an area
Between summer and cold seasons, temperature changes widely, as is commonly known. However, the external environmental temperature also affects their control and distribution mechanism. Hot and cold weather affects cooling equipment, energy consumption, heat distribution across different areas, and its ability to retain the required temperatures. Additionally, the sun's position on the wall of an area also impacts the temperature profile of the attached area.
All the factors mentioned above and alike alter the temperature throughout a specific area, department, or equipment and change the temperature requirement and fulfillment.
Temperature mapping help determine deviations in temperature during different seasons. It is also helpful in determining the equipment's behavior, and the equipment's operational parameters for an optimum temperature distribution.
Hindrance in airflow
It is common in pharma-critical areas that airflow faces resistance and hindrance during its flow in an area. This can be mainly due to the design of the facility, physical objects, and under or over-capacity of the blowing components. Certain spots within an area face temperature (and other environmental parameters) variations when this happens.
These variations are intense in corners, while ...
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