Reliable temperature monitoring and accurate mapping
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More than 22,000 Dyzle sensors worldwide monitor the storage conditions of medicines and vaccines in real time.
Temperature monitoring
In the pharmaceutical and healthcare industries, the use of temperature monitoring is mandatory. Dyzle has been providing a validated solution specifically made for this target group for over 20 years. Dyzle’s temperature monitoring is versatile and suitable for any environment or device where measuring temperature and other parameters is crucial.
Temperature mapping
To store drugs or vaccines, you must determine whether the room or object is suitable for them. This is done by performing a temperature mapping. Dyzle has developed a procedure for this which is pragmatic and fully compliant with all guidelines. We provide the complete process, from mapping to reporting. Our motto is first time right!
Looking for more information? Dyzle has the answer.
What is temperature monitoring?
Temperature monitoring is a system that continuously measures, records and monitors the temperature of an environment, product or device. The goal is to ensure that the temperature remains within specific limits, often prescribed by regulatory guidelines, quality standards or product requirements.
How does temperature monitoring work?
Dyzle's solution works with sensors that continuously measure environmental factors such as temperature, humidity and pressure. The data is sent in real time to an online environment, where it is recorded, analyzed and monitored. In case of deviations from the set limits, you immediately receive an alert via e-mail, text message or an app, allowing you to take quick action
Is temperature monitoring mandatory?
Yes, temperature monitoring is mandatory in both the pharmaceutical and healthcare sectors. In these sectors, companies must comply with guidelines. This contains regulations for temperature monitoring that apply not only to the storage of different types of drugs and vaccines, but also to requirements during delivery and shipment
What are the requirements?
In a GDP (Good Distribution Practice) and GMP (Good Manufacturing Practice) environment, companies are required to monitor temperature critical products during production, storage and transportation. Temperatures must be continuously monitored and meet predetermined limits to ensure the quality and safety of products such as drugs and vaccines. Temperature monitoring systems must be validated and report deviations immediately.
What is mapping?
Temperature mapping is a validation activity that involves measuring the temperature in a room, equipment or transportation device. The goal is to detect temperature variations and verify that all areas meet required specifications. Mapping is often performed in storage areas, refrigerators, freezers and transportation equipment and is essential in the pharmaceutical and healthcare industries to meet GDP and GMP guidelines.
How does mapping work?
In mapping, sensors are strategically placed to measure temperature at multiple points in a room, device or conveyance. Over a set period of time, data are collected to identify temperature variations and hot spots. The results are analyzed to verify that the environment is adequate to store temperature-sensitive products.
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Yes, performing temperature mapping is mandatory for companies that have a GDP and/or GMP license. It demonstrates that storage and transport environments are suitable for temperature-sensitive products. The IGJ checks the implementation and assurance of mapping during audits.
What are the requirements?
The requirements are defined in guidelines such as the GDP guideline and documents from organizations such as the World Health Organization (WHO), the International Air Transport Association (IATA, CEIV Pharma program) and the International Society for Pharmaceutical Engineering (ISPE). These describe the requirements that temperature mapping must meet.
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