Can the ventilation of GMP clean rooms beswitched off overnight?
晚上能否關閉GMP潔凈室的通風系統?
The ventilation systems of clean roomsconsume a lot of energy, especially power for the ventilating fan,refrigerating capacity for cooling and dehumidification in summer as well asheating for warming and steam for humidification in winter. Therefore, thequestion comes up again and again whether one might switch off the ventilationof the rooms overnight or when they are not used in order to save energy.
潔凈室的通風系統耗費巨大能源，特別是通風系統的風扇、夏天致冷和除濕以及冬天加熱和加濕用蒸汽。因此，一直就有這個問題：公司是否可以在晚上或不用的時候關閉房間的通風，以節約能源？
It is not advised to switch off the ventilation systemcompletely, it is rather advised not to do it. Premises, pressure conditions,microbiology, everything would be out of control during that time. This wouldmake the subsequent measures for the restoration of the GMP-compliant statevery complex because each time a requalification would be necessary to reachthe normal GMP-compliant state.
一般不建議完全關閉通風系統，事實上建議不要這樣做。設施、壓力條件、微生物，在此期間所有東西都會不受控制。這會讓之后的恢復GMP符合狀態所需的措施非常復雜，因為每次都要做再確認，來達到正常的GMP符合狀態。
But a reduction in the performance of the ventilationsystems (reduction of the air volume by reducing the performance of theventilation system) is possible, and is already carried out in some companies.Here too, however, the GMP-compliant state must be achieved prior to using theclean room again and this procedure must be validated.
但是，可以降低通風系統的功率（通過減少通風系統的功率來減少換氣量），已經有一些公司在這么做了。但是，在重新使用潔凈室之前還是必須達到GMP符合狀態，并且該程序必須經過驗證。
For this purpose the following points must be observed:
為此必須要觀察以下幾點：
The reduction can only be carried out so far that theclean room specific limits prescribed for the relevant case are not violated ingeneral. These limits have to be defined in each case for the operating statusand the reduction mode including permissible minimum and maximum values, suchas clean room class (particle count with equivalent particle size), productspecific values (temperature, relative humidity), pressure conditions (pressuredifference between the rooms). Note that the values in reduction mode have tobe chosen in such a way that the facility has reached the GMP-compliant statein due time before production begins (integration of a time program). Thisstate depends on different parameters such as building material and performanceof the system etc. The pressure conditions should be maintained all thetime, this means that a reversion of the flow direction is not allowed.
降低通風系統的功率只能達到一定程度，因為要保證總體來說不違背相關案例中潔凈室指定限度。在每個案例中，這些運行狀態下的和降低功率狀態下的限度必須定義，其中包括允許最小和最大值，例如潔凈室級別（塵粒數和相當的粒徑）、產品特定的值（溫度、相對濕度）、壓力條件（房間之間的壓差）。注意，在降低功率的模式下的值的選擇必須使得設施在生產開始之前的規定時間內（時間計劃結合在其中）達到GMP符合狀態。此狀態取決于不同的參數，例如建筑材料和系統性能等。應在所有的時間內都維持壓力條件，這表示不允許氣流逆向。
Furthermore, the installation of an independent cleanroom monitoring system is recommended in any case in order to constantlymonitor and document the above mentioned clean room specific parameters. Thus,the conditions of the area concerned can be monitored and documented at anytime. In the case of deviations (reaching of a limit) and in the individualcase it is possible to access the measurement and control technology of theventilation system and to carry out the relevant adjustments.
還有，建議安裝一個獨立的潔凈室監測系統，這樣可以連續監測并記錄上述潔凈室指定參數。這樣，所關注的區域的條件應可以在任何時間進行監測和記錄。如果有偏差發生（達到限度），在個案中有可能具備測量和通風系統控制技術，進行相關調整。
During the reduction attention should be paid toensuring that no unpredicted external interfering influences such as theentry of persons are allowed. For this the installation of a correspondingentry control is advised. In the case of an electronic locking system the entryauthorisation can be linked with the above mentioned time program as well aswith the independent clean room monitoring system so that entry is authorisedonly subject to compliance with the predefined requirements.
在降低風機功率時，要注意確保沒有非預期的外來干擾影響，例如，人員進入。這種情況建議使用相應的人員出入控制。如果使用的是電子鎖系統，出入權限可以與上述時間計劃相關聯，以及與獨立的潔凈室監測系統相關聯，這樣，出入授權必須要符合預定的要求。
In principal, both states must be qualified first andthen requalified in regular intervals and the customary measurements for theregular operating status such as the recovery time measurement in case of acomplete failure of the facility must be carried out. In the case a clean roommonitoring system exists it is in principal not required - as mentioned above -to carry out further measurements at the start of operations after reductionmode if the procedure is validated. Special focus should be put on theprocedure of restarting since temporary reversions of the flow direction arepossible, for instance.
原則上來說，兩種狀態都必須先確認，然后進行定期再確認。通常，常規運行狀態下的測量，例如設備完全失效情形下恢復時間測量是必須要進行的。如果存在有潔凈室監測系統，程序經過驗證的話，原則上不需要---如上所述---在降低通風功率后重新開始運行時進行進一步測量。特別要注意的是重新開始運行時的程序，因為，比如氣流方向短時逆向是有可能發生的。
All in all about 30 % of the energy costs can be saveddepending on the mode of operation and the shift model but additionalinvestment costs might have to be offset.
總體來說，根據運行模式和當班模式的不同，大概能節約30%左右的能源，但可能會被額外的投資成本所抵消。
