潔凈室的通風(fēng)系統(tǒng)耗費巨大能源，特別是通風(fēng)系統(tǒng)的風(fēng)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(guān)閉房間的通風(fēng)，以節(jié)約能源?
The ventilation system of the clean room consumes a great deal of energy,
especially the fan of the ventilation system, the steam for cooling and
dehumidification in summer and for heating and humidifying in winter. So the
question has always been: can the company turn off the ventilation of the room
at night or not to save energy?
凈化工程公司工程師一般不建議完全關(guān)閉通風(fēng)系統(tǒng)，設(shè)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(fù)GMP符合狀態(tài)所需的措施非常復(fù)雜，因為每次都要做再確認，來達到正常的GMP符合狀態(tài)。
一些公司通過減少通風(fēng)系統(tǒng)的功率來減少換氣量，降低通風(fēng)系統(tǒng)的功率，但是，在重新使用潔凈室之前還是必須達到GMP符合狀態(tài)，并且該程序必須經(jīng)過驗證。
Purification engineering engineers generally do not recommend complete
shutdown of ventilation systems, facilities, pressure conditions, microbes, and
during this period everything will be uncontrolled. This complicates subsequent
steps to restore GMP compliance, since revalidation is required each time to
achieve normal GMP conformance.
Some companies reduce ventilation by reducing the power of the ventilation
system, but before reusing the clean room, GMP compliance must be achieved, and
the program must be verified.
為此小編必須提醒注意：
降低通風(fēng)系統(tǒng)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(guān)案例中潔凈室指定限度。在每個案例中，這些運行狀態(tài)下的和降低功率狀態(tài)下的限度必須定義，其中包括允許最小和最大值。注意，在降低功率的模式下的值的選擇必須使得設(shè)施在生產(chǎn)開始之前的規(guī)定時間內(nèi)達到GMP符合狀態(tài)。
In this context, attention must be drawn to:
Reduce the power of the ventilation system to a certain extent, as it is
necessary to ensure that it does not violate the cleanroom limit specified in
the case in question. In each case, the limits at these operating states and in
the reduced power state must be defined, including the allowable minimum and the
maximum. Note that the selection of values in reduced power mode must enable the
facility to reach GMP compliance within a specified time prior to the start of
production.
還有，建議安裝一個獨立的潔凈室監(jiān)測系統(tǒng)，這樣可以連續(xù)監(jiān)測并記錄上述潔凈室指定參數(shù)。這樣，所關(guān)注的區(qū)域的條件應(yīng)可以在任何時間進行監(jiān)測和記錄。
在降低風(fēng)機功率時，要注意確保沒有非預(yù)期的外來干擾影響，例如人員進入。這種情況建議使用相應(yīng)的人員出入控制。如果使用的是電子鎖系統(tǒng)，出入權(quán)限可以與上述時間計劃相關(guān)聯(lián)，以及與獨立的潔凈室監(jiān)測系統(tǒng)相關(guān)聯(lián)，這樣，出入授權(quán)必須要符合預(yù)定的要求。
In addition, it is recommended that a separate cleanroom monitoring system
be installed to continuously monitor and record the specified parameters. In
this way, conditions in the area of concern should be monitored and recorded at
any time.
In reducing fan power, care should be taken to ensure that there is no
unexpected external interference, such as personnel entry. This situation
suggests the use of appropriate personnel access control. If an electronic lock
system is used, access rights may be associated with the above time plan and
with a separate cleanroom monitoring system, so that access authorization must
comply with predetermined requirements.
原則上來說，兩種狀態(tài)都必須先確認，然后進行定期再確認。通常，常規(guī)運行狀態(tài)下的測量，例如設(shè)備完全失效情形下恢復(fù)時間測量是必須要進行的。如果存在有潔凈室監(jiān)測系統(tǒng)，程序經(jīng)過驗證的話，原則上不需要---如上所述---在降低通風(fēng)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(fā)生的。
總體來說，根據(jù)運行模式和當(dāng)班模式的不同，大概能節(jié)約30%左右的能源，但可能會被額外的投資成本所抵消。
In principle, both states must be confirmed first and then periodically. In
general, measurements in normal operation state, such as recovery time
measurement in the case of complete failure of equipment, must be carried out.
If a clean room monitoring system exists and the program is verified, further
measurements are not required in principle-as described above-at the time of
restarting operation after reduced ventilation power. It is important to note
that the program should be restarted because, for example, short-term reverse of
the flow direction is possible.
Overall, depending on the operating mode and shift mode, it can save about
30% of the energy, but may be offset by additional investment costs.
