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.
On this page, you can look into:
- What temperature monitoring is, and why it is important
- The different types of temperature monitoring systems
- The 4 monitoring devices that make up a monitoring solution
- Temperature monitoring solution for your industry
- 8 compliance requirements of monitoring you should know
- FAQ about temperature monitoring
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"
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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.
What is a temperature monitoring system?
First things first. At its core, systems monitoring temperature work like this:
- 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).
- The data is either automatically or manually transferred to a centralized platform.
- 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.
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.
Free compliance guide
6 strategies to spend (way) less time on manual temperature compliance.
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.
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
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
Covers vast spaces with remote monitoring, sensor networks for spatial data, and HVAC system integration.
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.
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.
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.
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.
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
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:
- 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.
- 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.
- 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.
- ISO 17025: The golden standard for testing and calibration labs, making sure your temperature recordings are accurate. Learn more about ISO 17025.
- ICH Q10 (Pharmaceutical Quality System): Covers the whole pharmaceutical lifecycle, blending GMPs with quality systems and risk management.
- EU Annex 11 (Europe): Similar to FDA 21 CFR Part 11, but focuses on digital records in the European pharmaceutical sector.
- WHO Guidelines for Good Storage Practices: A global guideline to ensure correct storage conditions.
- 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.
7 questions and answers about temperature monitoring
Frequently asked questions about temperature and humidity monitoring.
Automated temperature compliance in one place – no gaps
Be in full control of your temperature monitoring at all times. Learn more in the free product catalog.
3 ways to learn more
Everything you need to know about temperature monitoring systems
21 CFR Part 11 compliant monitoring systems: What to look for?
How to unify temperature compliance to minimize manual work
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