Ensure product safety with temperature mapping for storage spaces. Learn the criteria, data collection, and reporting process for optimal conditions.
How do you know if a storage space, refrigerator, or freezer is suitable for storing temperature-sensitive products, such as medicines? And how do you determine the best places to take measurements?
Although climate control systems, refrigerators, and freezers offer the ability to set the space at a certain temperature, you may wonder if that temperature is consistent throughout the entire space.
How can you be sure that the temperature where you place sensitive materials is within safe limits? To what extent do different seasons affect this? And in the event of an audit or inspection, do you have instant access to the correct and validated data?
The answers to these questions are obtained through temperature mapping, also known as a temperature study. For companies with a GDP or GMP license, this is mandatory, but even if it is not required for your organisation, temperature mapping is advisable. It provides insights and answers that are crucial for quality and control.
Temperature mapping generally consists of 3 steps to obtain a good understanding of the conditions:
Criteria and protocol
First, research is conducted on the space to be monitored, whether it’s:
We gather as much information as possible about the desired situation and establish acceptance criteria based on applicable guidelines. We also create the test protocol, detailing how the temperature mapping will be carried out, where sensors will be placed, and what tests will be performed.
With thorough preparation, data collection takes place using sensors placed in predetermined locations, following the established protocol. This is where the actual mapping occurs. Wireless sensors are particularly suitable for this. A wireless sensor system is easy to set up in the space and can be easily removed after the test.
After processing all the data, a comprehensive report of the temperature mapping is generated. The report includes the protocol, as well as all cold and hot spots and points where the most temperature fluctuations occurred.
The report concludes with conclusions and recommendations to ensure the space can be used optimally for storing sensitive products.
The raw data and calibration certificates of the sensors used are also provided with this report, allowing compliance with regulations to be proven at any time. With the valuable information from the temperature study, you have all the answers at hand.
Once the temperature mapping is completed, the space is ready for use. Often, a seasonal mapping follows later, in summer and winter, to investigate the effect of high and low outside temperatures on the space. This is conducted according to a similar protocol as the initial temperature study, and is therefore less labor-intensive and costly.
You can, of course, perform temperature mapping yourself if the knowledge is available within your organisation. With a do-it-yourself set of sensors, software, and sufficient knowledge of the steps to be taken, you can undertake the task.
However, an external partner can often expedite the necessary steps due to specialization and experience. Wireless Value can fully assist you in conducting temperature mapping with its powerful and advanced wireless sensors. Want to know more? Please visit our website to find out more.Temperature mapping by Wireless Value