The question whether a disinfected surface has to be kept wet for the duration of the exposure time has reached us time and again. It seems like a statement keeps going around about this being a regulatory requirement.

消毒過的表面是否必須在暴露時間內保持濕潤的問題一次又一次地出現在我們面前。似乎有一種說法一直在說這是一項監管要求。

However, this isn't described in any European regulations known to us. It is not correct that the EN method is described thusly, either. The EN generally doesn't intend for surfaces to be kept wet during the exposure time. In accordance with EN 13697, though, exposure times lie at 5 min for bacteria and 15 min for yeasts and molds. Since 100 µl of disinfectant are applied to the surfaces, they almost always stay wet during this short exposure time. The norms therefore do not specify the wetting time, but the amount of disinfectant to be applied in a test. After that, one lets the product take effect for the specified exposure time (no matter whether the surface dries during that time or stays wet). The same goes for longer exposure times as found in national listings like the disinfectant list of theVAH (Germany), the listing of AFNOR or the product specifications of many disinfectants.

然而，這在我們所知的任何歐洲法規中都沒有描述。歐洲標準（EN: European Norm）方法也沒有這樣的描述，歐洲標準通常不打算在暴露時間內保持表面濕潤。但是，根據EN 13697，細菌的暴露時間為5分鐘，酵母和霉菌的暴露時間為15分鐘，由于將100 μ l的消毒劑噴灑于表面，因此在短時間內它們幾乎總是保持濕潤的。因此，標準沒有規定濕潤時間，而是規定了在測試中使用的消毒劑的量。之后，讓產品在規定的暴露時間內生效（無論在此期間表面是干燥還是保持濕潤）。同樣的情況以下國家規定的暴露時間持續更長，如VAH（德國）的消毒劑清單，AFNOR（法國）的清單或許多消毒劑的產品規格。

Now, there may be concerns in practice that the application in rooms/cleanrooms with an elevated air exchange rate will result in significantly faster drying in practice than during test methods (or during validation on a laboratory scale) and that the efficacy of the disinfection procedure might actually be negatively affected. In that case the monitoring data of long-standing procedures should provide insight into whether there actually is a lack of efficiency. Is that the case - or when a new disinfection procedure is being implemented - the actual drying time on site could be determined and the reduction during that time assessed in the laboratory testing/validation. This would mean that during laboratory testing, the disinfectant would be deactivated after the determined drying time in practice and the efficacy tested. If this is case and the reduction actually isn't sufficient, an increased concentration could be a way to shorten the exposure time.

現在，在實踐中可能會擔心在空氣交換率較高的房間/潔凈室中應用會導致實際干燥速度明顯快于測試方法(或在實驗室規模上驗證)，并且消毒程序的功效實際上可能會受到負面影響。在這種情況下，對長期程序的監測數據應有助于了解是否確實缺乏效率。在這種情況下，或者在實施新的消毒程序時，可以確定現場的實際干燥時間，并在實驗室測試/驗證中評估該時間內的減少情況。這意味著在實驗室測試期間，消毒劑將在實際確定的干燥時間和效力測試后失效。如果是這種情況，減少實際上是不夠的，增加濃度可能是一種縮短暴露時間的方法。

In general, however, it is valid that a disinfecting agent which has been applied to a microorganism cell maintains its effect on/in a cell even after the environment has dried.

然而，一般來說，即使環境已經干燥，應用于微生物細胞的消毒劑在細胞上保持其作用也是有效的。

It also needs to be considered that the microorganism concentration in a laboratory test is significantly higher than the germ count in an actual clean room (106 cells, depending in the method). For that reason, even with a lowered reduction rate on a laboratory scale, the limits normally set aren't exceeded in practice, and the monitoring values comply with the requirements.

還需要考慮的是，實驗室測試中的微生物濃度明顯高于實際潔凈室中的細菌數量(106個細胞，具體取決于方法)。因此，即使在實驗室規模的減少率偏低，在實踐中也沒有超過通常設定的限值，監測值符合要求。

以上是ECA在2017年9月發布的文章，新版EU GMP附錄1在2023年8月25日生效，博主未在其中找到需要保持濕潤的規定。

中國GMP第一百四十三條規定：清潔方法應當經過驗證，證實其清潔的效果，以有效防止污染和交叉污染。清潔驗證應當綜合考慮設備使用情況、所使用的清潔劑和消毒劑、取樣方法和位置以及相應的取樣回收率、殘留物的性質和限度、殘留物檢驗方法的靈敏度等因素。

在2023版中國GMP指南上冊《無菌制劑》中有提到：消毒劑接觸時間（潤濕時間）應經過驗證，并在實際操作中建立手段控制并監控是否達到規定的接觸時間限度。