Ensuring the integrity of products in a blood bank

Blood banks take great care with the temperature of storage of their blood products, after all, any change can damage the products. To be sure that the devices used to control and record temperature in these spaces are working correctly, it is important to perform periodic calibration with a reliable company. Check out this article by the Metrology Analyst at NOVUS Felipe de Loura da Rosa and learn how metrology assists in quality assurance.

The care and restrictions that a blood bank needs to have in order to give reliability to its patients are many, after all, have you ever stopped to think about how and where samples, donor blood bags, plasma, among other blood products are stored?

These products are stored in refrigerated chambers, thermal chambers, freezers and ultra freezers, equipment specially manufactured to maintain temperature sensitive products. However, how to ensure that the equipment responsible for storage is functioning properly, and that the product will not suffer any damage caused by the temperature change?

Through a thermal qualification of performance and the calibration of the temperature meters, it is possible to make sure the accuracy of the equipment.

The importance of making qualifications and calibrations

Imagine that a refrigerated chamber that stores blood bags (must be stored at temperatures between 2 ° C to 6 ° C) is missing the measurement at 4 ° C; or, imagine that the camera does not return to its original range after a door opening; or that some part of this chamber may be cooling more or less than the specified temperature range. In any of the imagined cases, the product will suffer irreversible damage, therefore the extreme importance of making the thermal qualifications of performance and calibrations in all the equipment that, in general, can interfere in the quality of the final product.

The calibrations of the temperature sensors are performed through direct comparison with a calibrated temperature standard, where all are introduced in a thermal medium (thermostatic bath or dry block calibrator). Calibration is performed at the desired temperature points. A calibration certificate is generated that brings identification, manufacturer, serial number (if any), type of sensor, among other requirements, in addition to the error and uncertainty that the equipment presented during calibration.

The thermal qualification of performance in equipment that stores products such as blood, plasma, samples, etc. is performed as follows:

12 temperature sensors are installed on the internal part of the equipment, one sensor must be together with the equipment sensor and the others distributed in such a way that they can cover the entire work volume, as we can see in the image above.

The equipment must be qualified with load, that is, it must contain products that are stored daily. The thermal performance qualification is performed for an average of 24 hours, during which the equipment must undergo door openings, in order to verify the return performance for the temperature limits.

At the end of the qualification, a purposeful shutdown of the energy is carried out for five minutes in order to find out if in that time the temperature will exceed the limits that are already pre-defined.

After the entire process is completed, temperature data is collected so that a certificate can be generated with the results. In addition to the results, the certificate must include identification of the equipment, manufacturer, serial number, model, dimensions, graph of temperature readings, photos of the equipment, drawing with the distribution of the sensors, conclusion, etc.

How do I keep my equipment always calibrated?

The NOVUS Metrology Laboratory uses high performance and precision data loggers and Pt100 sensors to measure temperatures during the calibration – qualification process, delivering reliable results.

Periodic calibration of equipment and thermal performance qualifications are of great importance to ensure the perfect functioning of equipment that stores sensitive products. Having a reliable company that always uses high-precision equipment offers even more reliability to the methods and, therefore, greater safety for health institutions and patients using blood components and blood products.