| GMP潔凈室的通風(fēng)系統(tǒng)晚上是否可以關(guān)閉？ |
Can the ventilation of GMP clean rooms be switched off overnight?
GMP潔凈室的通風(fēng)系統(tǒng)晚上是否可以關(guān)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.
潔凈室的通風(fēng)系統(tǒng)耗費(fèi)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(gè)問題：公司是否可以在晚上或不用的時(shí)候關(guān)閉房間的通風(fēng)，以節(jié)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(guān)閉通風(fēng)系統(tǒng)，事實(shí)上建議不要這樣做。設(shè)施、壓力條件、微生物，在此期間所有東西都會(huì)不受控制。這會(huì)讓之后的恢復(fù)GMP符合狀態(tài)所需的措施非常復(fù)雜，因?yàn)槊看味家鲈俅_認(rèn)，來達(dá)到正常的GMP符合狀態(tài)。
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(fēng)系統(tǒng)的功率（通過減少通風(fēng)系統(tǒng)的功率來減少換氣量），已經(jīng)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(dá)到GMP符合狀態(tài)，并且該程序必須經(jīng)過驗(yàn)證。
For this purpose the following points must be observed:
為此必須要觀察以下幾點(diǎn)：
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(fēng)系統(tǒng)的功率只能達(dá)到一定程度，因?yàn)橐ＷC總體來說不違背相關(guān)案例中潔凈室指定限度。在每個(gè)案例中，這些運(yùn)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，例如潔凈室級(jí)別（塵粒數(shù)和相當(dāng)?shù)牧剑?、產(chǎn)品特定的值（溫度、相對(duì)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(shè)施在生產(chǎn)開始之前的規(guī)定時(shí)間內(nèi)（時(shí)間計(jì)劃結(jié)合在其中）達(dá)到GMP符合狀態(tài)。此狀態(tài)取決于不同的參數(shù)，例如建筑材料和系統(tǒng)性能等。應(yīng)在所有的時(shí)間內(nèi)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(gè)獨(dú)立的潔凈室監(jiān)測(cè)系統(tǒng)，這樣可以連續(xù)監(jiān)測(cè)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(shí)間進(jìn)行監(jiān)測(cè)和記錄。如果有偏差發(fā)生（達(dá)到限度），在個(gè)案中有可能具備測(cè)量和通風(fēng)系統(tǒng)控制技術(shù)，進(jìn)行相關(guān)調(diào)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 authorisation can be linked with the above mentioned time program as well as with the independent clean room monitoring system so that entry is authorised only subject to compliance with the predefined requirements.
在降低風(fēng)機(jī)功率時(shí)，要注意確保沒有非預(yù)期的外來干擾影響，例如，人員進(jìn)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(shí)間計(jì)劃相關(guān)聯(lián)，以及與獨(dú)立的潔凈室監(jiān)測(cè)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 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(tài)都必須先確認(rèn)，然后進(jìn)行定期再確認(rèn)。通常，常規(guī)運(yùn)行狀態(tài)下的測(cè)量，例如設(shè)備完全失效情形下恢復(fù)時(shí)間測(cè)量是必須要進(jìn)行的。如果存在有潔凈室監(jiān)測(cè)系統(tǒng)，程序經(jīng)過驗(yàn)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(yùn)行時(shí)進(jìn)行進(jìn)一步測(cè)量。特別要注意的是重新開始運(yùn)行時(shí)的程序，因?yàn)?，比如氣流方向短時(shí)逆向是有可能發(fā)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(jù)運(yùn)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(huì)被額外的投資成本所抵消。 |
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