• What temperature monitoring is, and why it is important
• What is a monitoring solution?
• 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

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

Through a temperature monitoring system, 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.

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, and even minor fluctuations can compromise quality.

Ensuring a consistent thermal environment is therefore essential to maintain the quality of everything from medicine 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 - and this is secured through reliable, constant monitoring of the environment.

Failing to monitor and maintain the right conditions can lead to product quality issues, unreliable research, compliance failures, and financial losses. As such, Inadequate control can result in reduced credibility in a market where precision is paramount as well as ineffective treatments jeopardizing patient safety.

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

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.

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.

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.

A monitoring 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.

A monitoring solution 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 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 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 solution tailored to your needs.

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.

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):