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如何設(shè)定潔凈室壓差報警?如何打開緩沖間的門?

嘉峪檢測網(wǎng)        2025-02-24 20:54

ISO 14644標準中提出潔凈室壓差監(jiān)測的要求,如下:

 

關(guān)于壓差報警限的制定,建議設(shè)定為日常監(jiān)測上限-(2~3Pa)或壓差下限+(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).

觀察和記錄正常操作范圍后,建議對壓力報警裝置設(shè)定一個壓力報警范圍值,對于一個正壓裝置,設(shè)定所觀察到的最低壓力值-2~3Pa(建議值)作為報警值;對于一個負壓裝置,則+2~3Pa(建議值)作為報警值。

 

關(guān)于壓差報警,允許對壓差報警設(shè)定延時,以滿足日常操作需要(如進出開門),但需要合理確定該項活動所需要的時間,并以此確定延時。

 

“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.

 

通常需要延遲報警或行動警報,以允許潔凈室的正?;顒樱缛藛T進出開關(guān)門。仔細觀察典型的或預(yù)期的正常偏差的持續(xù)時間是確定適當(dāng)?shù)臅r間延遲的必要條件。超出正常持續(xù)時間的偏差應(yīng)激活報警。

 

有關(guān)緩沖間門的要求,除非安裝充氣密封(equipped with inflatable seals),否則開門后壓差存在泄漏(客觀事實)。

 

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.

 

當(dāng)人員或物料從一個潔凈室或潔凈區(qū)移動到另一個潔凈室或潔凈區(qū)時,氣閘(緩沖間)的設(shè)計有助于保持壓差。氣閘的設(shè)計或操作使一個相對的門總是關(guān)閉。然而,除非這些門裝有充氣密封,否則當(dāng)其中一扇門打開時,通過氣閘的泄漏量通常比兩扇門都關(guān)閉時更大(客觀事實)。

關(guān)于緩沖間壓差的監(jiān)測要求:應(yīng)監(jiān)測開關(guān)門后壓差恢復(fù)的情況,確保壓差恢復(fù)后才能打開另一道門。

 

It is necessary to test and document these normal variations to properly set alert and action levels for pressure alarms. Follow this procedure:

有必要測試和記錄這些(開關(guān)門)常規(guī)壓差變化,以便為壓力報警設(shè)定適當(dāng)?shù)木浜托袆酉?。參照以下程序進行評估:

 

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;

 

關(guān)閉所有的門和傳遞窗,定義所有設(shè)備的運行狀態(tài),觀察穩(wěn)定狀態(tài)下所選擇的房間或區(qū)間的壓差,注意由于風(fēng)或其它動態(tài)影響產(chǎn)生的小的常規(guī)波動;

 

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;

 

每個緩沖間、傳遞窗或轉(zhuǎn)移艙,打開所有的門,一次打開一邊的門,注意房間或區(qū)間壓力波動。關(guān)門,確認壓差回到其原始值;

 

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.

泄漏通道,例如門周邊泄漏,應(yīng)進行評估,作為潔凈間設(shè)計的一部分,以確保為此泄漏做出了足夠的空氣平衡余量。

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來源:GMP辦公室

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