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.
U OQ-u treba odrediti izvedbu relevantnog pomoćnog sustava i softverski sustav treba testirati simuliranjem uvjeta kvara.
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.
Temperaturu i vlažnost treba pratiti u cijelom području predkondicioniranja tijekom dovoljno dugog razdoblja da se pokaže da se vrijednosti održavaju unutar željenih raspona. Treba odrediti temperaturu i vlažnost na više mjesta raspoređenih po cijelom području predkondicioniranja;
Temperaturu treba pratiti u cijelom grijanom području prozračivanja tijekom dovoljno dugog razdoblja da se pokaže da se vrijednosti održavaju unutar željenih raspona. Treba odrediti temperaturu na više mjesta raspoređenih po cijelom području prozračivanja;
Sterilizator bi trebao obaviti test curenja prije OQ kako bi se osigurala sigurnost. (pod vakuumom za subatmosferske cikluse ili pod vakuumom i pod tlakom za super atmosferske cikluse)
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.
………
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;
IF YOU WANT TO KNOW MORE ABOUT IQ IN ETO STERILIZATION PROCESS
