Qualification of Cooling Equipment
Save time by using Eupry’s user friendly Qualification Kit with accredited DANAK ISO17025 calibrations and 21CFR PART11 compliance. The Kit comes in a handy flight case with the amount of temperature sampling points (dataloggers) needed, a wireless base station and extra batteries.
All dataloggers has been START-calibrated and an EXIT-calibration is performed at a scheduled date or when needed by the customer.
Qualification of cooling equipment is a key process that ensures that stored goods are kept within certain temperature limits when operated.
When operating cooling equipment, dynamics of the equipment will change according to loading, use and age. Therefore it is important that the distribution of temperature is qualified or mapped before use, and at regular time intervals. This ensures and documents that the temperature is uniform and stable inside the equipment, and that all locations inside the equipment can be used for storing sensitive assets.
Use Eupry’s Qualification Kit for qualification of your equipment
Eupry provides a convenient way for you to carry out a successful qualification of your equipment. We will provide you with a qualification kit, that includes calibrated data loggers. It is everything you need to qualify all of your equipment.
Eupry’s Qualification Kit
- Realtime, wireless data loggers – gives the ability to stop a mapping exercise if it will not succeed and you don’t have to download information from each data logger to a computer.
- Automatic wireless export of data – Going from OQ to PQ does not require taking the data loggers out of the climate chamber, refrigerator or cooler.
- Download documents with one click – no manual document handling.
- Calibrated data loggers – The qualification kit is calibrated at Eupry’s accredited laboratory when handed in. This ensures fast inspection and calibration. Calibration certificates can be located online in Eupry logger.
- Historic data access – Assess how your equipment is changing over time with access to 5 years of temperature data.
- DANAK Accredited ISO17025 calibration
- 21CFR PART11 compliant
- IQ,OQ,PQ documentation
Got any questions?
Eupry are experts in temperature monitoring, validation and compliance, get in touch if you have any questions!
How does Eupry’s Qualification Kit Work
- Eupry delivers the kit with calibrated sensors (either accredited or traceable), with an MPE of 0.5°C
- Place the data loggers according to agreed qualification plan
- Connect the base station
- Carry out the exercise
- Print out our specially designed report
Why choose Eupry’s Qualification Kit?
- The kit is easy to use, it comes complete with all the equipment and documentation you will require.
- We make sure you get the type of calibration you need fast and flexibly.
- Eupry’s laboratory is accredited by DANAK in ISO17025
- The system is cost effective – you carry out the qualification yourself.
- You are able to follow the qualification process live and interrupt the test if the equipment needs to be adjusted.
- Save many hours on faulty tests by doing it live
How do I qualify a refrigerator?
Qualification, or mapping, is always performed with regards to internal SOPs, and as directed by the quality department in an organisation, although some general guidelines can be mentioned. The following guide represents a general approach, which can be used as a guideline or inspiration for a qualification protocol of your own.
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1. Choose data loggers to be used for qualification of equipment
In most cases, 9 data loggers are sufficient for performing the qualification or mapping exercise. Dependent on how much information is available from the manufacturer, a lower number of data loggers can be used.
The data loggers should at the very least live up to the following standards:
- Be able to continuously measure temperature, at least every 5 minutes.
- Have a valid calibration (either accredited or traceable, depending on external requirements) with an MPE (Maximum Permissible Error) of maximum 0.5°C for refrigerators and freezers.
- Be uniquely identifiable from the other data loggers.
2. Perform qualification
Qualification is performed by placing data loggers in the defined positions, and recording the position of each data logger.
After the setup, a series of measurements can be carried out, of which some important ones are described below:
- 24 hour unloaded monitoring
After letting the equipment settle in temperature, the temperature is monitored for a 24 hour period in an unloaded unit. This is to ensure that the temperature is homogenous and stable. Minimum and maximum temperatures are recorded along with an average temperature.
- 24 hour loaded monitoring
After letting the equipment settle in temperature, the temperature is monitored for a 24 hour period in a loaded unit, with pieces of simulating loads. This could be vials with glycole or boxes to simulate a maximum loading of the equipment.
This is to ensure that the temperature is homogenous and stable. Minimum and maximum temperatures are recorded along with an average temperature.
- Time to stable temperature
From a turned off state, the equipment is turned on, after which the monitoring is started. The time it takes to reach a temperature within limits is recorded, and can be used to determine how fast the equipment can recover from a turned off state.
- Time to deviation
- Starting with the equipment in temperature stable state, the power to the equipment is cut. The time it takes for the equipment to reach critical limits is recorded, and gives an indication of how long the equipment can be out of power before a non-conformity is made.
3. Analyse data
When qualification has been performed, the data can be gathered and analyzed.
For every series, the average, maximum and minimum temperatures should be documented, together with largest difference (homogeneity) between dataloggers during the exercise.