洁净区压差监测的要求
原创 翻译组  GMP办公室 
洁净室压差监测的要求，如下：关于压差报警限的制定，建议设定为日常监测上限-（2~3Pa）或压差下限+（2~3Pa）

“After observing and recording the normal operating ranges, it is recommended that a pressure setting for the warning pressure measurement device be selected a few Pascal below the lowest pressure observation for a
positive-pressure configuration, or a few Pascal above in a negative-pressure
configuration (guidance value 2 Pa to 3 Pa).
观察和记录正常操作范围后，建议对报警压力装置设定一个压力报警范围值，以高低之间的范围来进行控制（建议数值的设定范围为2-3Pa）”

关于压差报警，允许对压差报警设定延时，以满足日常操作需要（如进出开门），但需要合理确定该项活动所需要的时间，并以此确定延时。

“It is often necessary to delay the alert or action alarm to allow for normal activity in the cleanroom, such as the opening of doors to permit entry and exit of personnel. Careful observation of the duration of typical or expected normal deviation is necessary to determine appropriate time delay.Deviations that extend beyond the normal durations should activate warnings.
正常设定収生警戒或者行动报警过程中会存在有延时的设定，以此保证洁净间的常觃活动，比如：开门允许人员的迚出，在该过程中需仔细观察所执行的正常或预期的时间，以此确定报警的延时。若超过常觃时间造成偏离系统将会激収报警。”

有关缓冲间门的要求，除非安装气密封（equipped with inflatable seals），否则开门后压差存在泄漏。

Air locks are designed to help maintain pressure differentials as personnel or
materials move from one cleanroom or clean zone to another. Air locks are designed or operated so that one opposing door set is always closed. However, unless the doors are equipped with inflatable seals, the leakage through the airlock is usually greater when one of the opposing door sets is open than when they are both closed.
缓冲间是设计来帮助在人员或物料从一个洁净区或洁净间移动至另一个洁净区/间时维持压差。缓冲间的设计或操作应保证其中一边的门总是保持关闭。然而，除非门采用了充气密封，否则当一边的门打开时，通过缓冲间产生泄漏通常大于两边门都打开。

关于缓冲间压差的监测要求：应监测开关门后压差恢复的情况，确保压差恢复后才能打开另一道门。

It is necessary to test and document these normal variations to properly set alert and action levels for pressure alarms. Follow this procedure:
需要测试和记录这些常规变化，以便为压力报警设定适当的警戒和行动限。参照以下程序进行评估：

close all doors and pass-through hatches, define the operational status of any equipment, and observe the steady-state pressure differentials between the selected rooms or zones noting the small, normal fluctuations that will occur due to wind and other dynamic effects;
关闭所有的门和传递窗，定义所有设备的运行状态，观察稳定状态下所选择的房间或区间的压差，注意由于风或其它动态影响产生的小的常规波动；
for each airlock, pass-through hatch or transfer chamber, open allthe doors, one set of opposing doors at a time, and note room- or zone-pressurevariation. Close the doors and confirm that the pressure differentials return to theiroriginal values;
每个缓冲间、传递窗或转移舱，打开所有的门，一次打开一边的门，注意房间或区间压力波动。关门，确认压差回到其原始值；
leakage paths, such as those around doors, should be evaluated as part of a cleanroom design to ensure adequate allowance is made in the air balance for such leakages.
泄漏途径，例如门周边泄漏，应进行评估，作为洁净间设计的一部分，以确保为此泄漏做出了足够的空气平衡余量。