正确密封的灭菌室对于在整个循环过程中维持所需的环氧乙烷浓度和压力条件至关重要. 以下密封性测试在空室上进行，以检测任何可能危及无菌保证或操作员安全的不可接受的泄漏. 这些程序与性能验证协议一致 工业环氧乙烷灭菌器.

一般测试要求

所有泄漏测试必须在空灭菌室中进行. 自动测试周期完成后, 引入过滤空气，直至腔室压力恢复到环境大气压力的 ±5 kPa 以内. 对于非自动测试方法, 在进行测量之前，必须采取等效措施以实现相同的压力平衡.

如果需要的话, 压力监测开始前可设置300s±10s的稳定期. 这段时间, 所有连接到腔室的阀门均关闭，真空泵 (如果使用) 已停止. 随后的压力变化观测周期必须不少于 600 几秒钟内可靠地检测任何泄漏趋势.

负压泄漏测试

负压泄漏测试评估腔室保持真空的能力, which is critical for the evacuation phases of a sterilization cycle. The test pressure should not exceed the lowest set pressure of any sterilization cycle, 或者 -75 千帕, whichever is lower. This ensures the chamber is tested under the most demanding vacuum conditions it may experience in service.

Procedure: Evacuate the empty chamber to the specified negative test pressure. Close all valves connected to the chamber and stop the vacuum pump completely. After the optional stabilization period of 300s ±10s, monitor and record the pressure continuously for a minimum of 600 seconds. The pressure rise over this period must not exceed the allowable leak rate specified in the sterilizer’s performance documentation. Any increase beyond the limit indicates a potential breach in chamber integrity that must be investigated and corrected before the sterilizer is placed into service.

Positive Pressure Leak Test

The positive pressure leak test verifies the chamber’s ability to contain elevated pressures without leakage. The test pressure must be no lower than the highest set pressure of any sterilization cycle, ensuring the chamber is evaluated under worst-case positive pressure conditions.

Special considerations for heated chambers: If the test is performed in a heated chamber, temperature variations can influence pressure readings and affect the calculated leak rate. 所以, after reaching the test pressure, a stabilization period must be observed until the temperature stabilizes, plus an additional 120 seconds, before the monitoring phase begins. This compensates for any pressure changes caused by thermal effects.

With all valves closed and the pressure source isolated, record the pressure for at least 600 seconds. The pressure decrease during this period is evaluated against the specified leak rate limit. Consistent monitoring ensures that even minor leaks are detected and addressed promptly.