Data loggers for validation and routine monitoring

How do data loggers work?

From bottle loggers to pressure gauges, modern data loggers are similar in design. All models have one or more sensors that measure the desired physical parameter at regular intervals and record the measured value in an internal memory or transmit it directly to a receiver.

The interface of modern measuring devices is always digital and enables data transmission via radio or explicit readout as a USB data logger. The evaluation and presentation of the recorded data is carried out using specialized software, so that a professional evaluation of the measured data can be carried out on almost any PC. If it becomes apparent that the measured values have exceeded the specified limit values or that the cold chain has been interrupted during transportation, the software can issue a corresponding warning.

With simpler loggers, the focus can be purely on determining the measured values without direct transmission and evaluation, so that it must be read out as a USB data logger at a later time, for example.

What are typical features of data loggers?

Data loggers are designed to measure and record specific physical values so that they can then be transferred to a computer in real time or after a set interval. The type of measured values determined in this way depends entirely on the sensor of the data logger. Data loggers have different properties depending on the desired application:

• If data loggers are intended to indicate compliance with certain transportation conditions, such as temperature, humidity, etc., at first glance, this is sometimes done with a simple "OK" or "not OK" display on the logger. These loggers usually fulfill their task as "single use" loggers and are discarded after transport.
• If data loggers are used for routine monitoring, they are usually not removed but read on site via their display or the values are transferred to software in real time. This makes it possible to alert the user and intervene in a timely manner.
• Data loggers for extreme conditions, such as in autoclaves or heating ovens, are built without a readable display in order to withstand the high temperatures. These measuring devices are usually used for very limited time intervals and are read out retrospectively.

What components does a data logger consist of?

Data logger: The data logger itself is the central part of the system. It contains sensors for data acquisition and electronic circuits for signal processing. The data logger stores the recorded data either internally or on external storage media.
Sensors: Sensors are devices that record physical parameters such as temperature, humidity, pressure, conductivity or other measured values. They are connected to the data logger via cables or wireless connections and provide continuous measurement data.
Power supply: Data loggers require a reliable power supply. This can be provided by batteries, power from the mains or other energy sources.
Storage media: Data loggers store the recorded data on internal memory or on external storage media such as SD cards, USB drives or cloud services.
User interface: Most data loggers have a user interface that allows the logger to be configured, data to be displayed and settings to be made.
Software: Accompanying software allows the data logger to be configured, data to be displayed in real time and stored data to be analyzed.
Accessories: These include brackets, protective housings, cables, and mounting elements, which are required depending on the application.

Which standards and which processes are covered?

Data loggers for validation and routine monitoring in the medical sector must meet specific requirements. Our data loggers meet the requirements of the following standards:
ISO 17665, ISO 15883, ISO 11140-4, EN 285, EN 13060

Our data loggers can be used to monitor the processes in the following devices, among others:
Steam sterilizers, plasma sterilizers, FO sterilizers, washer-disinfectors, washer-disinfectors for endoscopes, DAC, careclave

What is validation?

In the medical and pharmaceutical field, validation refers to the process of demonstrating that medical devices, production facilities, processes and procedures meet established standards and requirements and provide consistent, reliable and safe results.
This validation process is critical to ensure the quality, efficacy and safety of medical devices and pharmaceutical products. It involves comprehensive assessment, documentation and verification of compliance with regulations and quality standards at every stage of development, manufacture and use.
Validation can include aspects such as the sterility of medical devices, the efficacy of pharmaceuticals, the accuracy of diagnostic equipment and process control in pharmaceutical production facilities. Validation ensures that products do not cause harm to patients and users and provide the intended medical benefit.

What is calibration & adjustment?

Calibration and adjustment of data loggers are important procedures to ensure that these devices provide accurate and reliable results. Calibration refers to the comparison of data logger readings with known reference values to detect and correct inaccuracies. This process ensures the accuracy of measurements and is particularly important in applications where precise data is critical.

Adjustment refers to the process of adjusting data loggers to ensure that they operate in accordance with their specifications. It is a process of fine-tuning where the data logger is returned to its original state. This may be necessary if the data logger drifts or provides incorrect measurements.