4 Reasons to Do Temperature Mapping at Your Facility in 2021
Temperature mapping has become an increasingly important practice for businesses that deal in environmentally sensitive products. This is especially true in industries for which compliance with specific security and safety measures and GxP (good practices) are mandatory.
As you may have already inferred from the name of this article, the temperature mapping process entails the three-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 necessary adjustments.
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
- Processing zones such as loading docks, packing & labeling areas, or manufacturing lines
- Clean rooms, autoclaves, or sterilizing areas
- Trucks, containers, or other types of transport equipment
Temperature mapping is in and of itself a vital GxP but there are many other reasons why you need to do this in your facility. Let’s hit the four most important ones.
- Your assets will be better protected
Temperature mapping can play a major role in ensuring the security and safety of your products and consumers, two of your biggest assets to consider when it comes to your company’s bottom line. In fact, this is the core goal of thermal mapping, notably in the case of food or drug manufacture, packaging, storage, and distribution.
For example, the last thing a food vendor wants is for meat, produce, or other temperature-sensitive products to be exposed to areas of heat pockets. If these products spoil and/or decline in quality, you will not just lose the money attached to those products; the risk to your assets also involves customer loss and punitive fees from relevant authorities.
Temperature mapping data can be coupled with knowledge of the impact of temperature on the overall quality, safety, and effectiveness of your products. When practicing temperature mapping you can set up preventive and control systems that will help protect your products, your consumers and other assets from harm.
Take medications and vaccines, for instance. The vast majority of these pharmaceuticals are exposed to manifold environmental settings throughout the process of production, transport, and storage. It’s important that each point in the supply chain is temperature-monitored so that any damaging changes can be noted before it’s too late. This can be incredibly helpful when protecting your assets.
- 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. Temperature mapping is usually a compliance requirement for highly regulated industries, such as the medical equipment, biotech, pharmaceutical, healthcare, and food & beverage industries.
This vital procedure can also be a mandatory part of an 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 regulations for humidity and temperature control.
Failure to comply with the temperature control regulations set by the FDA can cost your company dearly, in terms of financial, 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 pharma, 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 vaccine serum.
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 the best facilities can experience slight discrepancies in temperature that have a profound impact on the quality and safety of the products being processed or stored.
Thermal mapping solutions allow these regulated companies to demonstrate how their temperature-controlled units perform within predetermined parameters. By doing so, they 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 the mapping study, your facilities will be temperature mapped using a variety of stress tests such as power failure, open door, fan failure, pull-down tests, loading, and empty mapping. These are just a few examples of extreme scenario testing. The overarching goal is to determine whether the current system can sufficiently regulate the temperature in the controlled environment under adverse circumstances.
A thorough temperature mapping can help staff and regulators get a clearer picture of the facility. Such tests will help them figure out the optimum position for 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, be it a monitoring tool, autoclave, data logger, etc.
- Equipment repair: When any unit in the temperature-controlled space is repaired, replaced, or relocated, you want a temperature map to make sure it performs as expected.
- Seasonal changes: The temperature of storage spaces such as warehouses can be significantly affected by changes in outside conditions. This is particularly true during extreme seasons winter and summer. In these times of year, temp mapping data can provide decisive insights into how external temperature changes can affect your facility.
- It will identify potential risks
When it comes to regulated, temperature-sensitive products such as vaccines, drugs, and food, there is literally no room whatsoever for error. That’s why these products are subject to more testing, control, and scrutiny from regulatory authorities. Forward-thinking companies use temperature mapping to identify potential risks long before they become a costly problem.
The frequency of mapping, documentation, and the 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.
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, better protect 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.