The high-pressure sterilization pot achieves microbial inactivation through high-temperature and high-pressure steam, and its validation requires comprehensive evaluation from three aspects: physical parameters, chemical indicators, and biological monitoring to ensure that the sterilization process meets the requirements. The validation of high-pressure sterilization pots requires multidimensional methods to ensure their sterilization effectiveness standards. The core validation methods include chemical indicator method, biological indicator method, temperature distribution validation, and pressure distribution validation.
Common validation misconceptions and precautions
Neglecting "cold air exclusion": Failure to exhaust all cold air can result in local temperatures falling below the set value (such as when sterilizing at 121 ℃, the cold air area may only be 100 ℃), which is one of the main reasons for sterilization failure and needs to be tested in OQ and PQ.
Improper use of biological indicators: It is necessary to confirm that the indicators are within their validity period and the storage conditions (such as refrigeration at 2-8 ℃) meet the requirements; When placed, it should be tightly attached to the load to avoid hanging in the air (otherwise it cannot reflect the actual sterilization situation of the load).
Temperature probe calibration omission: The thermocouple used for verification needs to be calibrated once a year, and the calibration range should cover the sterilization temperature (such as 100-140 ℃) to avoid data distortion caused by inaccurate probes.
Unrealistic load simulation: The load during the PQ stage needs to be consistent with the actual use (such as the number of instruments, packaging method, liquid volume). If the simulated load is too light, it may mask the sterilization risk in actual use.
Suggestions for Verification Cycle and Frequency
Routine verification: Conduct comprehensive verification (including temperature distribution, pressure distribution, and biological indicator verification) at least once a year.
exceptional case:
Re validation is required after equipment maintenance, renovation, or relocation.
When sterilization parameters (such as temperature and time) change, they need to be revalidated.
When the sterilization effect is abnormal, it needs to be verified immediately.
Daily monitoring: Chemical indicators can be used for rapid screening during each sterilization cycle, while biological indicators can be sampled regularly (such as once a month).