How to master temperature monitoring in critical environments

Temperature monitoring is a compliance essential for drug distribution and logistics, pharma, biotech, and other regulated industries working with sensitive products. Here is why – and how to master it.

What is temperature monitoring?

Temperature monitoring is the practice of tracking temperature levels in an environment. Through a temperature monitoring system, the goal is to secure quality by making sure conditions around temperature-sensitive assets are viable.

Why is it important to monitor temperatures?

A large range of different products and materials are sensitive to temperature, and even minor fluctuations can compromise quality. Reliable monitoring is vital to ensure a consistent thermal environment for these products, and inadequate control can lead to reduced credibility, unreliable research, ineffective treatments jeopardizing patient safety, and financial loss.

Also check out: "7 questions and answers about temperature monitoring"

Smarter temperature monitoring with Eupry

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Eupry offers a connected process and wireless solution, gathering all your temperature compliance efforts under one (digital) roof to always have the data you need at your fingertips.

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  • "We have saved around 50-70% of the time we spent on temperature monitoring."

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    Senior Logistic Manager at Dechra Pharmaceuticals PLC

What is a temperature monitoring system?

First things first. At its core, systems monitoring temperature work like this:

  1. A network of temperature monitoring devices – most often in the form of data loggers with relevant sensors – continuously measures and records temperatures (and potentially also humidity levels).
  2. The data is either automatically or manually transferred to a centralized platform.
  3. The platform allows users to observe conditions, receive alerts if temperatures deviate from the set parameters, and maintain a trail of data for compliance purposes.

Some systems can also predict trends and suggest adjustments, making them an indispensable ally in protecting product integrity and meeting rigorous industry standards.

The different types of temperature monitoring systems

Temperature monitoring systems are the backbone of temperature compliance for many industries, from pharma and biotech to logistics and cosmetics.

Wired monitoring systems

A wired monitoring system relies on physical connections to transmit data from sensors to a central monitoring station. The need for running cables can make installation relatively inflexible and very costly. Previously, this setup has been critical in environments where wireless signals could be unreliable, but today many wireless temperature monitoring systems have solutions in place to handle this challenge.

Monitoring system – USB-based

Wireless USB-enabled monitoring systems use wireless data loggers that collect data, which is then manually downloaded via USB. Compared to wired systems, these solutions offer more flexibility. On the downside, they require significant manual work to both extract and locate data and can only be utilized when real-time surveillance is not needed.

Wireless monitoring system – Wi-Fi-based

More modern thermal monitoring systems will typically be not only wireless but also Wi-Fi-based. Like all monitoring systems, these solutions supply an overview of thermal conditions – but in this case, this happens in real time.

Wireless data loggers automatically send data to the system, providing live data that can be accessed from anywhere and eliminating the need for manual data exports and audit reporting. Alerts can be sent instantly to let you take immediate action. These solutions offer the highest level of convenience and are particularly valuable when an immediate response to temperature changes is critical.

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6 strategies to spend (way) less time on manual temperature compliance.

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Temperature monitoring for different equipment

Besides the way data is collected, temperature monitoring systems and devices can differ, depending on the specific environment or equipment they are tailored to.

Read more about temperature monitoring solutions for different types of equipment.

Freezer and fridge temperature monitoring system

Freezer and fridge temperature monitoring system

Features alarms for low temperatures and thermal sensors sustainable at extreme cold, essential for ULT freezers.

Laboratory temperature monitoring system

Laboratory temperature monitoring system

High-precision systems with high-accuracy sensors and calibration options, designed for pharma and biotech labs.

Walk-in cooler temperature monitoring system

Monitors large refrigeration areas with door sensors, energy usage tracking, and automated compliance reports.

Warehouse temperature monitoring system

Warehouse temperature monitoring system

Covers vast spaces with remote monitoring, sensor networks for spatial data, and HVAC system integration.

Storage container temperature monitoring system

Storage container temperature monitoring system

Adapts to external conditions with strategically placed sensors, wireless connectivity, and battery-powered routers.

4 different temperature monitoring devices

A monitoring system is typically made up of a variety of temperature monitoring devices that work in concert. Understanding the roles of these is key to implementing an effective temperature monitoring solution for your needs.

  • Sensors: Temperature sensors do the actual measuring. They come in different types, including thermocouples, RTDs, thermistors, and digital sensors, each suited to different ranges and environments.
  • Data loggers: Sensors and data loggers are often used synonymously, but in reality, while sensors do the measuring, the data loggers are the devices that collect and store this data for analysis.
  • Monitoring platform: Depending on the data logger and solution, data can be transferred through Wi-Fi or manual USB exports to an adjoining digital platform used for monitoring, analysis, and audit reporting.
  • Alarms: Alarms are the immediate response mechanism of a temperature monitoring system. Based on live data transfer and monitoring, alarm functionality can be programmed to trigger, for instance, SMS or email alerts when temperatures deviate from predetermined ranges.

By choosing the right combination of sensors, loggers, and alarms, and utilizing their integration capabilities, you can create a robust temperature monitoring system tailored to your specific needs.

Temperature monitoring solution for your industry

When seeking a temperature monitoring solution, it is essential to choose one that is compliant with the unique regulations of your sector.

Here are a few high-level things to consider based on your industry.

Also read: How to choose the right temperature monitoring system for your industry

Temperature monitoring for logistics

Durability and connectivity are key for temperature monitoring systems designed for drug distribution and logistics. Look for wireless solutions with robust data loggers, offsite monitoring capabilities, and mobile network connectivity.

Learn more

Temperature monitoring for pharma

Look for systems that take the complexity of evolving pharmaceutical regulations into account. Live monitoring and prompt alerts are needed due to the sensitive nature of many pharma products, and digital deviation handling, audit trails, and digital reporting can help ease your audit procedures.

Learn more

Temperature monitoring for biotech

Precision is non-negotiable in biotech. Opt for solutions that include accredited calibration, sensors with the required ranges and resolutions, full traceability, and support GLP practices.

Learn more

Gain full control over your temperature compliance

  • Print audit reports in 3 clicks
  • Reach quality experts 24/7
  • Calibrate without swapping devices

A major pitfall of conventional temperature compliance is disconnected (often manual) processes that leave room for critical tasks to slip through the gaps.

Eupry’s solution is temperature compliance done smarter.

Through an ISO-accredited process, patented technology, hands-on support, and automated solutions, we bring temperature compliance together to supply you with a single source of truth for ALL your temperature data.

"A short way of describing our experience with the solution is simply that it is really easy to use. Both to get started and work with in day-to-day operations."

Allan Toft Jacobsen, COO at European Sperm Bank

How Eupry’s temperature compliance solution works.

8 compliance requirements of temperature monitoring you should know

When navigating the world of temperature monitoring in areas like pharma, biotech, and logistics, here are some essential compliance requirements you should know:

  1. FDA 21 CFR Part 11: This one focuses on managing electronic (temperature) records and signatures. Note that, even though it is an FDA standard, it frequently applies to organizations outside the US. Learn more about 21 CFR Part 11 in temperature monitoring.
  2. GxP Regulations: Think of GxP (Good X Practices) as the big umbrella of quality rules. It covers different areas like GMP (making sure products are consistently manufactured according to quality standards), GLP (keeping lab research reliable and high-quality), GDP (for top-tier distribution practices), etc.
  3. ISO 9001: The International Organization for Standardization’s (ISO) standard for quality management systems to ensure products and services consistently meet customer and regulatory requirements.
  4. ISO 17025: The golden standard for testing and calibration labs, making sure your temperature recordings are accurate. Learn more about ISO 17025.
  5. ICH Q10 (Pharmaceutical Quality System): Covers the whole pharmaceutical lifecycle, blending GMPs with quality systems and risk management.
  6. EU Annex 11 (Europe): Similar to FDA 21 CFR Part 11, but focuses on digital records in the European pharmaceutical sector.
  7. WHO Guidelines for Good Storage Practices: A global guideline to ensure correct storage conditions.
  8. EudraLex Volume 4 (for EU): Guides manufacturing, importation, and distribution of medicinal products in the EU.

This surface-level walk-through is not exhaustive. The specific requirements for your temperature monitoring practice depend on your industry, product types, equipment, clients, and much more.

Learn more about regulations in temperature compliance (and how to live up to them):

FDA 21 CFR Part 11 compliance checklist

Simplify 21 CFR Part 11 compliance for your temperature monitoring with our 9-step checklist.

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Not to brag, but…

At Eupry, we are ISO 9001 certified, our lab is ISO 17025 accredited, and our temperature monitoring solution includes a specialized FDA 21 CFR Part 11 module.

7 questions and answers about temperature monitoring

Frequently asked questions about temperature and humidity monitoring.

1. What is temperature monitoring?

Temperature monitoring is the compliance process of continuously tracking and documentation of temperature levels within a controlled setting, which can range from refrigerators and freezers to storage containers and large-scale warehouses.

The goal is to monitor the surroundings to make sure that products and samples are kept under optimal conditions to uphold their quality and integrity.

Monitoring temperature – and often also humidity – is particularly critical, and consequently also a regulatory requirement, in industries that handle temperature-sensitive goods, such as pharmaceuticals, biotechnology, and logistics.

2. Why is it important to monitor temperatures?

Pharmaceutical products, biotech samples, and many other materials are often highly sensitive to both temperature and humidity levels.

Ensuring a consistent thermal environment is therefore essential to maintain the quality of everything from medications to valuable research are kept safe and can proceed without risk to efficacy or the well-being they are put in the world to protect.

Failing to monitor and maintain the right conditions can result in product quality issues, compliance failures, financial losses, and erode trust in a market where precision is paramount.

Following GxP guidelines, thermal monitoring is conducted during the extent of a product’s lifetime – from the development level to production, transport, and storage.

3. What is a temperature monitoring system?

A temperature monitoring system is a – more or less digital – solution designed to record and manage temperature data.

The systems can alert personnel to temperature deviations, allowing for prompt action to maintain compliance and product integrity.

The systems typically consist of: sensors that measure temperature data loggers to record the information software to monitor, analyze, and report on the data.

The exact features and combination of temperature monitoring devices depend on the specific product needs and regulatory requirements.

Also read: 9 frequent flaws in temperature monitoring systems.

4. When is temperature monitoring used?

Common applications span from the refrigeration of compounds in research laboratories to the storage of life-saving medicines in healthcare facilities, and the real-time temperature tracking of goods across global supply chains.

A rule of thumb is that if the product or material is sensitive to temperature variations or if its quality, safety, or efficacy could be compromised by deviations from a controlled temperature range, then temperature monitoring is necessary. This applies to all parts of the supply chain – from research and development to manufacturing and transport.

Pharmaceuticals, for example, require strict temperature control to maintain their therapeutic properties and ensure patient safety.

5. Which type of temperature sensors are the best fit?

Deciding which temperature sensors are the right fit for your monitoring setup should be based on your specific requirements. For instance, which resolution is optimal, and which operating range is relevant?

These decisions are again dependent on the regulatory requirements, product specifications, type of equipment, etc.

6. Where should you place temperature monitoring sensors?

The placement of temperature monitoring sensors should be strategic to ensure accurate and representative readings based on your unique risk assessment.

Some general considerations for placement:

  • Near entry points: Position sensors near doors, gates, windows, etc. – in other words, near locations that are prone to temperature fluctuations. Sensors near doors or other openings can alert you to critical temperature changes due to frequent opening and closing.
  • Near critical goods: Place sensors close to high-value or highly sensitive products to ensure their storage conditions are continuously monitored.
  • At different axes: Since temperature can vary at different levels, sensors should be placed at various heights within a storage unit. Think about the three axes, height, width, and depth, and make sure they are all covered.
  • Near technical installations: Technical installations often generate heat. If you have goods near these, make sure to also place sensors in the areas to make sure the temperature doesn’t exceed limits. Tip! Before even placing make sure to conduct a temperature mapping study that has verified that these areas are safe for storage.
  • Remote monitoring points: In larger facilities like warehouses, use remote sensors to monitor areas that are not frequently accessed by staff.

Note: It is crucial to follow industry guidelines and the specific requirements of the products being monitored to determine the optimal number and locations of sensors for comprehensive coverage.

Read more

7. Which temperature monitoring system should you choose?

Selecting a temperature monitoring system depends on your industry's unique needs. Logistics require robust, scalable solutions with reliable connectivity, while biotech benefits from customizable, high-precision systems. Pharma focuses on regulatory compliance and secure data handling, and cosmetics need flexible systems for fast product turnover.

Learn more about how to choose the right temperature monitoring system for your needs.

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3 ways to learn more

Everything you need to know about temperature monitoring systems

Everything you need to know about temperature monitoring systems

21 CFR Part 11 compliant monitoring systems: What to look for?

21 CFR Part 11 compliant monitoring systems: What to look for?

How to unify temperature compliance to minimize manual work

How to unify temperature compliance to minimize manual work

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