How can you differentiate between a mechanical failure and a process failure in steam sterilization?

Differentiating between a mechanical failure and a process failure in steam sterilization involves analyzing the sterilizer's performance data, indicator results, and the physical condition of the load. A mechanical failure refers to a malfunction of the sterilizer's hardware components, such as a faulty valve, a malfunctioning vacuum pump, or a damaged heating element. Signs of a mechanical failure include abnormal cycle parameters, such as failure to reach the required temperature or pressure, leaks, or unusual noises. A process failure refers to a failure to achieve the desired sterilization conditions, even though the sterilizer's hardware may be functioning correctly. Signs of a process failure include a failed chemical indicator or biological indicator test, or the presence of wet packs. To differentiate between the two, first review the sterilizer's cycle data to identify any deviations from the established sterilization parameters. If the cycle parameters are within the acceptable range, but the indicator results are failing, it suggests a process failure, possibly due to improper loading, packaging, or steam quality issues. If the cycle parameters are abnormal, it suggests a mechanical failure. A thorough investigation, including a physical inspection of the sterilizer and a review of maintenance records, is necessary to determine the root cause of the failure and implement appropriate corrective actions. For example, if the sterilizer is unable to achieve the required vacuum level, this indicates a mechanical problem. If indicators fail even though the sterilizer is working according to established parameters, the issue may be loading density or steam quality.