Calibration is the process of determining the deviation of a sensor according to an approved methodology. This is crucial in determining whether the sensor still meets specifications. At Dyzle, our digital temperature sensors are designed not to expire, which means that they basically do not need to be recalibrated. Over the past 15 years, we have performed tens of thousands of calibrations, or had them performed by our partners, without a Dyzle sensor operating beyond its specifications. This is in contrast to other sensors, such as resistance sensors (e.g. PT-100), which can deviate.
Which calibration options fit your needs?
Calibration requirements according to GDP guidelines:
Guidelines for calibrating sensors are set out in the Good Distribution Practice (GDP) guidelines, based on European legislation on medicinal products for human use (2001/83/EC). The most recent version of these guidelines came into force on Nov. 5, 2013. The Netherlands is obliged to comply with this legislation; therefore, the Medicines Act refers to the GDP guidelines.
Chapter 3 of the GDP guidelines, which deals with premises and equipment, addresses the requirements for calibrating sensors. Section 3.3 states, “Equipment used to control or monitor the environment where drugs are stored must be calibrated periodically based on a risk and reliability assessment. The calibration of equipment must be traceable to a national or international measurement standard.” Further, “devices that record temperature” are identified as important equipment. Often the guidelines also state that sensors should be recalibrated periodically, they do not specify the period or interval to be adhered to.
Calibration services from Dyzle:
Although Dyzle sensors do not expire, in many situations it is desirable or even required to have proof of this. We offer various solutions to suit your specific needs. Dyzle provides calibration as a service and strives to provide cost-effective solutions. We can work with you to create a statement or protocol to meet the requirements of the controlling authority or a customer of yours. We have had a reliability study performed on our sensors and calibration history. As a customer of Dyzle, you can take advantage of this study, the associated statement and our expertise at no charge to meet the guidelines while saving costs.
1-point calibration:
At the request of our customers, we have developed our own 1-point calibration. This does not require the sensors to be disassembled or expensive equipment. We digitally calibrate the sensors by comparing them with an RvA-accredited reference sensor, always at the working temperature of the sensor used. This method ensures that the sensor is calibrated within the range in which it is used, without interrupting data collection. The calibration certificate is available to you directly in Dyzle’s online environment. All certificates are kept there for a minimum of 7 years.
3-point calibration:
In some quality requirements, you want to determine sensor deviation over a wider range. Then you can choose to calibrate a sensor at different values, also called ranges. In many cases, you choose three different ranges; therefore, this is often called 3-point calibration. This method of calibration is often more expensive and also causes interruptions in data collection, which can lead to data loss and the generation of unwanted alarms.
Looking for advice on the best calibration methodology? Contact us today. We are happy to help!
