Temperature qualification study is a detailed process involved with lot of tests and evaluation to make sure that the asset is designed and established properly and is capable of preserving the popular temperature and humidity. After this complicated process, the asset is licensed as certified for engaging in and retaining the preferred tiers of temperature and humidity.
Main tests under the temperature qualification study
Design qualification system
Design qualification is studying that the asset is designed nicely to perform the favored function of accomplishing and preserving the favored temperature and humidity. This method will contain checking the layout factors with typical engineering practices and relevant requirements of country wherein the asset is maintained
Installation qualification procedure
Installation qualification is the technique of verifying that each one predominant components of the belongings are established and maintained as in line with the design and as in line with the tips of the producers of the respective devices. Also applicable neighbourhood pointers want to be examined.
Installation qualification is usually known as IQ.
Operation qualification procedure
Operation qualification is verifying techniques of operation of the whole property and its maximum critical components. All those want to be operated as in keeping with the manufacturer’s guidelines and SOPs carried out by using the individual.
Operation qualification is usually referred to as OQ.
All files including calibration certificates, preservation test lists, operation test lists and so forth. Need to be maintained as according to the written strategies which might be proven on this degree.
Temperature mapping study (and Humidity if required)
Please see our separate page on Temperature mapping study for info in this device.
What is Temperature and Humidity qualification process?
The only addition is that humidity is also protected under this study and all device associated with humidity additionally may be examined. The mapping study will humidity as well.
What are the deliverable end results of a qualification study?
- Facility mapping protocol and report (empty load) with detailed study trying out approach, consequences, statistics interpretation and recommendations for the managed-room temperature warehouses.
- Facility mapping protocol and document (full load – summer season & winter profile) with detailed study testing methodology, results, data interpretation and guidelines for the controlled-room temperature warehouses.
- Qualification protocols and reviews with targeted look at attempting out method, effects, facts interpretation and tips for the cold room.
- Certificate indicating effects of the asset and fundamental deviations if any
- Various charts indicating analysis of Temperature & Humidity at numerous places
- Various charts indicating evaluation of Temperature & Humidity sooner or later of precise operational situations as consistent with the protocol
- Excursions of Temperature & Humidity
- Hot points and Cold Points
- Recommendations for improvements if any
- Locations for placing non-forestall tracking devices (if applicable)
- Certificate of calibration for all data loggers used during the study.