OQ is undertaken to demonstrate the ability of the ETO STERILIZATION MACHINE to meet the performance requirements of its design specification.
During ETO STERILIZATION MACHINE OQ the following events need to be identified and substantiated.
In OQ, the performance of the relevant auxiliary system should be determined and the software system should be tested by simulating the fault conditions.
For the preconditioning room , sterilizer and aeration room, the pattern of air circulation and ventilation capacity throughout the chamber to be occupied by the sterilization load(s) should be determined. This can be performed by smoke tests in combination with the calculation of air change rates and anemometric determinations.
Temperature and humidity should be monitored throughout the preconditioning area over a period long enough to demonstrate that values are maintained within the desired ranges. The temperature and humidity in a number of locations distributed throughout the preconditioning area should be determined;
Temperature should be monitored throughout the heated aeration area over a period long enough to demonstrate that values are maintained within the desired ranges. The temperature in a number of locations distributed throughout the aeration area should be determined;
The sterilizer should do leak test before OQ to ensure safety.(under vacuum for subatmospheric cycles or under vacuum and at pressure for super atmospheric cycles)
For sterilizer,a chamber wall temperature study should be completed to verify adequate temperature uniformity provided by the jacket heating system. The study should characterize the temperature profile for comparison on a periodic basis to ensure the system continues to operate effectively.
Repetition cycles shall be performed (at least three times) to demonstrate reproducibility of control and operation effects;The temperature of the injected EO-gas should be within the volatizer specification or above the boiling point of EO (10,7°C at atmospheric pressure);
In empty chamber OQ exercises, the recorded temperature range, within the usable chamber volume during EO or inert gas exposure, of ±3?of the average recorded chamber temperature at each time point should be obtained after an equilibration period. When the OQ exercise is carried out using a loaded chamber, then the±3? tolerance might not be achievable.
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Annual OQ
Review of OQ should include an assessment of the equipment performance and engineering changes that were made during the year to ensure that the results from the original OQ are still valid. In order to do so, it is common practice to perform periodic requalification of equipment and should include:
review of IQ status of equipment;
assessment of trends in equipment performance;
temperature and humidity profiles of the preconditioning areas;
chamber temperature profile;
e.temperature profile of the aeration room;
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