Temperature mapping is an essential step in determining permanent monitoring equipment placement. Specifically, the mapping study helps organizations determine precisely what areas to monitor, which variables to log, and where to place data loggers. For this reason, conducting temperature mapping is a crucial part of building a solid and effective environmental monitoring system.
The right monitoring solution will provide accurate environmental data to ensure that temperatures are continuously within specifications. If deviations occur, the system will signal an alarm so that corrective measures can be quickly executed to protect assets. But such protection begins with deciding where to place data logging devices for optimal temperature monitoring and quality control.
Therefore, temperature mapping is a core GxP (good practice) method that organizations can use to meet regulatory compliance and protect temperature-sensitive processes, materials, and products. Let’s find out exactly what temperature mapping entails.
Temperature Mapping Defined
Organizations in regulated industries often deal with processes and materials sensitive to environmental factors such as temperature and humidity. A good example is medications, which must be kept at certain temperatures during production, storage, and shipment. Exposing medications to temperatures outside of the desired range can result in unsafe drugs and poor patient outcomes.
On numerous occasions wrong temperatures have resulted in foodborne illness outbreaks, product recalls, and messy lawsuits. The WHO estimates that at least one in every two vaccine units distributed worldwide ends up being wasted due to logistical problems such as temperature deviations during transit.
We can’t overestimate the importance of ensuring that temperatures remain consistent in all environments where sensitive products are handled. That’s where temperature mapping comes into play.
Temperature mapping is a meticulous environmental study involving the three-dimensional mapping of temperature-controlled environments. The primary objective is to generate a data-driven rationale for deciding where to place data logging devices by mapping the changes and differences in temperature within controlled spaces.
The study is often carried out to design a new environmental monitoring system or to review and optimize an existing temperature tracking solution.
Most organizations conduct temperature mapping on the individual process level — especially in mission-critical spaces like warehouses, storage freezers, heating & treatment ovens, clean rooms, or packaging spaces. It can also be carried out on a large scale across an entire distribution and supply chain.
In either case, the mapping study is an essential GxP step in documenting and validating that temperature-controlled spaces, like medical refrigerators, thermal shipping containers, and cold warehouses are suitable for their job. Periodic mapping of a facility can also help an organization determine if its preventive maintenance efforts effectively ensure temperature consistency.
Temperature Monitoring vs. Temperature Mapping
You can be forgiven for thinking continuous temperature monitoring and temperature mapping refer to the same practice. They are quite different.
Temperature monitoring entails the continuous collection and documentation of temperature data in environments where sensitive products are manufactured, distributed, or stored. Data loggers are employed to monitor environmental conditions perpetually, typically to ensure temperatures remain consistent and comply with applicable regulations and industry standards.
Temperature mapping involves placing many more data loggers all over the areas of interest to the study. The aim is to create a data representation (i.e., the map) that paints the distribution of temperature conditions inside the controlled space in question.
Temperature mapping isn’t a continuous process. The test is only done periodically over the study period and across a variety of operational conditions. For instance, warehouses can be mapped when empty, at half capacity, and filled. It can also be performed across specific stress conditions, including during winter/summer, power outages, equipment breakdown, or when the doors are open.
Ultimately, both temperature monitoring and temperature mapping are designed to help protect assets by minimizing the impact of temperature deviations.
Why is Temperature Mapping Important?
According to Dickson, the results of a temperature mapping study can be helpful when creating plans for routine monitoring, developing a Standard Operating Procedure (SOP), or recommending the best remedial strategy. The benefits are HUGE:
Helps maintain regulatory compliance: Organizations in regulated industries must meet temperature requirements set by the Food and Drug Administration (FDA), District Attorney, Environmental Protection Agency, and other regulatory agencies. Temperature control is mandatory for those dealing with medical devices, pharmaceuticals, and food.
The last thing you want is to receive a citation for non-compliance from the FDA. It can ruin your business relationships, brand perception, and customer loyalty. Having a documented temperature mapping strategy can help meet regulatory requirements and boost your likelihood of passing audits.
The following regulated industries rely heavily on temperature mapping for regulatory compliance:
- Food and beverage
- Medical and environmental research laboratories
- Medical device and biotech manufacturing and testing
- Cold chain logistics
- Aerospace manufacturing and aircraft monitoring
Protect your valuable assets: Temperature mapping data can help you implement a robust monitoring system that effectively prevents and detects harmful deviations. That can help you protect valuable assets, such as temperature-sensitive materials.
Improve operational efficiency: Temperature mapping offers a data-driven strategy for determining your current and future monitoring needs. You can reduce operating costs, improve workflows, and enhance overall operational efficiency. For instance, having the proper temperature controls in place can minimize disruptions and expenses when problems arise.
Enhances safety: Since temperature mapping evaluates all essential environments, you can ensure certain conditions are always safe for your products and employees. Delivering temperature-assured products can also guarantee that consumers are safe.
Temperature Mapping Application Examples
Temperature mapping can prove indispensable for specific processes, facilities, or settings. The most common areas include:
Warehouses: Conducting temperature mapping must be a core part of operational qualification (OP) and performance qualification (PQ) procedures when designing, implementing, or reviewing a storage area or warehouse.
Cold rooms and refrigerators: A temperature mapping study can reveal areas within the fridge, cold room, or freezer that would be perfect for data logger placement. It may also help identify ‘hotspots,’ such as areas close to doors or cooling fans & coils.
Shipping equipment: Thermal shipping equipment can also be temperature-mapped much in the same way as cold rooms and warehouses.
Incubators and ovens: Here, the data loggers can be used to map areas of interest in both air and median temperature.
Sterilizing and testing facilities: This applies to autoclaves, clean rooms, and enclosed labs, where uniformity of temperature and humidity conditions must be ensured.
Temperature mapping is also essential in ascertaining temperature-controlled spaces such as ultra-low temperature freezers, stability chambers, and processing workspaces.