寧波澳门国际生物醫藥有限公司
行業動態
GMP潔淨室的通風係統晚上是否可以關閉?
Can the ventilation of GMP clean rooms be switched off overnight?
GMP潔淨室的通風係統晚上是否可以關閉?
The ventilation systems of clean rooms consume a lot of energy, especially power for the ventilating fan, refrigerating capacity for cooling and dehumidification in summer as well as heating for warming and steam for humidification in winter. Therefore, the question comes up again and again whether one might switch off the ventilation of the rooms overnight or when they are not used in order to save energy.
潔淨室的通風係統耗費巨大能源,特別是通風係統的風扇、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 system completely, it is rather advised not to do it. Premises, pressure conditions, microbiology, everything would be out of control during that time. This would make the subsequent measures for the restoration of the GMP-compliant state very complex because each time a requalification would be necessary to reach the normal GMP-compliant state.
一般不建議完全關閉通風係統,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製。這會讓之後的恢複GMP符合狀態所需的措施非常複雜,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 ventilation systems (reduction of the air volume by reducing the performance of the ventilation system) is possible, and is already carried out in some companies. Here too, however, the GMP-compliant state must be achieved prior to using the clean room again and this procedure must be validated.
但是,可以降低通風係統的功率(通過減少通風係統的功率來減少換氣量),已經有一些公司在這麽做了。但是,在重新使用潔淨室之前還是必須達到GMP符合狀態,並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 the clean room specific limits prescribed for the relevant case are not violated in general. These limits have to be defined in each case for the operating status and the reduction mode including permissible minimum and maximum values, such as clean room class (particle count with equivalent particle size), product specific values (temperature, relative humidity), pressure conditions (pressure difference between the rooms). Note that the values in reduction mode have to be chosen in such a way that the facility has reached the GMP-compliant state in due time before production begins (integration of a time program). This state depends on different parameters such as building material and performance of the system etc. The pressure conditions should be maintained all the time, this means that a reversion of the flow direction is not allowed.
降低通風係統的功率隻能達到一定程度,因為要保證總體來說不違背相關案例中潔淨室指定限度。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,例如潔淨室級別(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。此狀態取決於不同的參數,例如建築材料和係統性能等。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 clean room monitoring system is recommended in any case in order to constantly monitor and document the above mentioned clean room specific parameters. Thus, the conditions of the area concerned can be monitored and documented at any time. In the case of deviations (reaching of a limit) and in the individual case it is possible to access the measurement and control technology of the ventilation system and to carry out the relevant adjustments.
還有,建議安裝一個獨立的潔淨室監測係統,這樣可以連續監測並記錄上述潔淨室指定參數。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係統控製技術,進行相關調整。During the reduction attention should be paid to ensuring  that no unpredicted external interfering influences such as the entry of persons are allowed. For this the installation of a corresponding entry control is advised. In the case of an electronic locking system the entry isation can be linked with the above mentioned time program as well as with the independent clean room monitoring system so that entry is ised only 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幹擾影響,例如,人員進入。這種情況建議使用相應的人員出入控製。如果使用的是電子鎖係統,出入權限可以與上述時間計劃相關聯,以及與獨立的潔淨室監測係統相關聯,這樣,出入授權必須要符合預定的要求。
In principal, both states must be qualified first and then requalified in regular intervals and the customary measurements for the regular operating status such as the recovery time measurement in case of a complete failure of the facility must be carried out. In the case a clean room monitoring system exists it is in principal not required - as mentioned above - to carry out further measurements at the start of operations after reduction mode if the procedure is validated. Special focus should be put on the procedure of restarting since temporary reversions of the flow direction are possible, for instance.
原則上來說,兩種狀態都必須先確認,然後進行定期再確認。通常,常規運行狀態下的測量,例如設備完全失效情形下恢複時間測量是必須要進行的。如果存在有潔淨室監測係統,程序經過驗證的話,原則上不需要---如上所述---在降低通風功率後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 saved depending on the mode of operation and the shift model but additional investment 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。
 
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