Temperature mapping has become an increasingly important practice for businesses that deal in environmentally sensitive products. This is especially true in industries where security and safety are mandatory from both a compliance and GxP (good practice) standpoint.
As you may have already inferred from the name, GxP entails a multi-dimensional mapping of deviations, differences, or changes in temperature within a controlled storage space or chamber. The main goal is to learn how temperature is distributed within a controlled environment, enabling you to spot any inconsistencies and thus implement the necessary improvements.
This periodic undertaking can be applied to various areas of your facility, such as:
- Cold rooms, freezers, and refrigerators for the storage of temperature-sensitive products
- Warehouses
- Processing zones such as loading docks, packing & labeling areas, or manufacturing lines
- Ovens
- Incubators
- Clean rooms, autoclaves, or sterilizing areas
- Trucks, containers, or other forms of transport equipment
Temperature mapping is a vital part of GxP but there are many other reasons why you need to perform this task in your facility. Let’s hit the four most important ones.
Your assets will be better protected
Temperature mapping can play a big role in ensuring the security and safety of your products and consumers, two of your company’s biggest assets. This is the core goal of thermal mapping, especially in the case of food or drug manufacture, packaging, storage, and distribution.
For example, the last thing you want as a food vendor is for your meat, produce, or other temperature-sensitive products to be exposed to areas of heat pockets. If your products spoil and/or decline in quality, you will not only lose the money attached to those products; the risk to your assets also involves customer loss and punitive fees from relevant authorities.
It’s clear that temperature mapping data can be coupled with knowledge of the impact of temperature on the overall quality, safety, and effectiveness of your products. This way, you can set up preventive and control systems that will help prevent your products from being harmed and thus protect them, your consumers, and other assets.
Take medications and vaccines, for instance. The vast majority of these pharmaceuticals are exposed to manifold environmental settings during the whole process of production, transportation, and storage. It’s important that all of the points in the supply chain are temperature-monitored so that any damaging changes can be noted before it’s too late.
It may be required by regulators
Producing, storing, and maintaining a consistent batch of items that comply with the standards put forward by regulatory agencies is crucial for businesses that handle temperature-sensitive products. More importantly, temperature mapping is usually a compliance requirement for highly regulated industries, such as medical equipment, biotech, pharmaceutical, healthcare, and food & beverage products.
This vital procedure can also be a mandatory part of the accreditation process, such as CAP or ISO, for instance. At the very least, these heavily regulated firms must comply with the Food and Drug Administration (FDA), which regulates the safe storage and handling of medical devices, blood samples, pharmaceuticals, and foods. Specifically, the FDA’s CFR Title 21 includes the regulations for humidity and temperature control.
Failure to comply with these temperature control regulations set by the FDA can cost your company dearly, in terms of money, time, and reputation loss. A quick look at FDA inspection citations for the past decade or so reveals numerous cases of temperature control issues, particularly for pharmaceuticals, food, and biotech products. A more recent example is the case of Emergent BioSolutions, a vaccine maker, which forced Johnson & Johnson to throw away 15 million doses of its COVID-19 inoculation.
It’s important to note that temperature mapping is critical no matter how soundly built your storage chamber is, or how well your manufacturing process is designed. Even slight discrepancies in temperature can have a profound impact on the quality and safety of the products being processed or stored.
Along with that, thermal mapping solutions allow these regulated companies to demonstrate that their temperature-controlled units perform within predetermined parameters. By doing so, companies can make sure they meet regulatory compliances. Dickson has a temperature mapping guide that explains these benefits in more detail.
You will understand your facility better
As part of a mapping study, your facilities will be temperature mapped using a variety of other stress tests like power failure, door open, fan failure, pull-down tests, loading, and empty mapping, just to quote a few examples of extreme scenario testing. The overarching aim here is to determine whether the current system can sufficiently regulate the temperature under adverse circumstances in the controlled environment.
A thorough temperature mapping can help those involved get a better and clearer picture of the facility. This way, they will be able to figure out the optimum position of permanent data loggers and the perfect location of the actual storage units for temperature-sensitive items.
A more complete understanding of the facility is especially important in certain situations, such as:
- Installation of new equipment: Whenever a new piece of temperature-critical equipment is brought in, a mapping study will help determine the ideal spot to install it, whether it is a monitoring tool, autoclave, data logger, etc.
- Equipment repair: when any unit in the temperature-controlled space is repaired, replaced, or relocated, you’d want a temperature map to make sure it performs as expected.
- Seasonal changes: the temperature in storage spaces such as warehouses can be significantly influenced by changes in outside conditions. This is particularly so in extreme seasons like winter and summer, during which temp mapping data can provide decisive insights into how they affect your facility.
It will identify potential risks
When it comes to regulated, temperature-sensitive products such as vaccines, drugs, and food, there is no room whatsoever for error. That’s why these products are subject to more testing, control, and scrutiny from regulatory authorities. For this reason, forward-thinking companies use temperature to identify potential risks long before they become a costly problem.
The frequency of mapping, documentation, and level of testing often boils down to your company’s risk evaluation strategy. You can incorporate many different variables into your risk assessment when conducting a temperature mapping, such as product sensitivity to deviations in temperature, effect on product quality, and impact on consumers.
Conclusion
Temperature mapping is a highly detailed, meticulous process that should be performed regularly in facilities that handle temperature-sensitive products. Carrying out an appropriate mapping study will help ensure regulatory compliance, provide better protection of your assets, detect potential risks, and provide great insights into your facility. Ultimately, this will lead to a more efficient temperature monitoring and control system, reducing chances of downtime and improving the general GxP environment.
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