Explosion Proof Refrigerator Validation and Qualification Service
Ellab is a provider of onsite cGMP explosion proof refrigerator validation and qualification services. Explosion proof refrigerators are controlled storage units in which hazardous materials can be stored safely in temperature controlled conditions. Some of these materials can be considered flammable and volatile, which means that extra care must be taken in their storage. Another commonly used term for these units is intrinsically safe. The goal of these units is to reduce the risk and prevent the triggering of an explosion inside of the chamber.
Laboratory Refrigerator Validation and Qualification Service
Ellab is a provider of onsite cGMP laboratory refrigerator validation and qualification services, which often include temperature mapping. A laboratory refrigerator is an environmental chamber used to store in-process product samples for ongoing quality control studies. Refrigerators are used to store a wide variety of materials. Refrigerators can be considered scientific, and may be specialized such as chromatography refrigerators. A refrigerator provides temperature control throughout the entire storage cabinet providing an optimal temperature environment.
Commonly, refrigerators may be viewed as laboratory/pharmaceutical, blood bank/plasma, chromatography laboratory & scientific refrigerators, sliding glass door/pass-thru refrigerators and flammable storage/explosion resistant refrigerators. In the life science industry there can be both reach-in and walk-in refrigerators used in many facilities.
The purpose of qualification is to ensure that the equipment or refrigerator is properly installed, works correctly and produces the specified performance outcomes under routine operating conditions. A qualification requires a sufficient number of electronic data logging monitors to ensure that qualification activities can be carried out correctly. Furthermore, suitable computer equipment and software is needed to store and analyze the data. The data loggers should have the following characteristics:
- Be appropriate for the specific task and the intended operating temperature range
- Provide a reliable and continuous reliable record of time and temperature data
- Have an appropriate temperature range so that all anticipated temperature extremes can be recorded.
- Have a user-programmable data sampling period allowing time intervals to be set in the range from one minute or higher and with sufficient memory for the intended length of the study and the chosen recording interval
- Have a NIST-traceable 3-point calibration certificate and have a guaranteed error of no more than ±0.5°C at each calibration point.
- Recorded time-temperature data should be downloadable to a computer data acquisition system for subsequent analysis.
- Data storage and analytical software should comply with applicable regulatory requirements such as 21 CFR Part 11