Temperature Mapping Services Guide

What is Temperature Mapping?

Many industrial, laboratory and manufacturing processes deal with products that are temperature-sensitive, like 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 of Temperature Mapping

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.

Purpose and Importance of Temperature Mapping

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:

  • Proximity to doors that are frequently opened
  • Distance from cooling fans
  • Air circulation within the space
  • The quantity of products stored in the area
  • Body heat from personnel working in the space
  • Heat radiating from machinery and devices, and more

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:

  • Fresh and treated foods
  • Medication
  • Vaccines
  • Dairy products
  • Meat products

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.

What are Temperature Mapping Services and Why are they Required?

Regulatory authorities like the FDA and Health Canada have increased the pressure on drug and pharma manufacturers to comply with GMP guidelines and requirements for temperature-controlled storage. Compounded by the elimination of financial risks related to equipment failure, they have become a vital part of consumer safety as well as losses associated with product quality or associated failures within storage and logistics operations.

Today’s pharmaceutical manufacturing and SCM (supply chain management) organizations have a greater responsibility than ever before. They need to have a clear understanding of processes that could impact product quality or patient safety, as well as every aspect of the procedure involved.

Creating a temperature profile of critical storage equipment or locations is essential, and a critical part of managing risks related to product quality and increasing patient safety. To balance the returns from your investment, you may have to balance these elements combined with the costs of packaging and your environmental monitoring programs, against your staffing requirements.

How to Perform Temperature Mapping

Temperature mapping, like most other critical processes, is conducted in accordance with a structured process. Follow these steps for the temperature mapping process:

  1. Create an adequate validation plan with protocols that incorporate a logical and scientific method that justifies each step
  2. Identify areas that can affect quality, along with risk and develop a temperature mapping protocol to determine the locations for sensors
  3. These locations should be able to eliminate the probability of products being affected due to temperature variance
  4. Select the technologies that are suited for the job, like a data logger, stability chamber and others
  5. Set up equipment for mapping and conducting tests in conditions that the system may be exposed to
  6. Develop a comprehensive report describing the results and summarize the actions that must be taken to prevent temperature-related issues

Temperature Mapping vs. Temperature Calibration

Temperature mapping is often confused with calibration and validation of temperature-sensing equipment or devices. However, a GMP facility is usually continuously monitored for changes in temperature with temperature probes that are routinely calibrated. This may suggest that calibration is all that is needed by regulatory authorities, but there are quite a few differences.

Temperature mapping includes:

  • The impact of external intervention like door openings, circulation and power failures
  • Identification of areas that remain at higher or lower temperatures
  • Variations between the maximum and minimum temperature at a single point in the system
  • Temperature variations that occur over the entire area as a whole
  • The time-period within which the temperature variations are outside the acceptable limit

Role and Importance of Temperature Mapping Services

Temperature mapping is essential for monitoring the temperature throughout the system for sectors and industries where incorrect or fluctuating temperatures can affect final product quality and compliance with industry standards. It’s crucial for ensuring that the cooling system can adequately control the temperature of each specific product.

Apart from online systems, any backup cooling temperature-control systems should also be rigorously checked, so you can prove your adherence to health and safety standards through temperature monitoring and mapping, even in less-than-ideal circumstances.

It’s definitely a good idea to hire professional service providers with experience in temperature mapping for this task, especially if your business is related to the pharmaceutical or food manufacturing sectors.

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