GMP News
24/02/2016

Can the ventilation of GMP clean rooms be switched offovernight?

GMP洁净室的通风设备在晚上能否关闭？

译:Aurora  校：Levi

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 asheating 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.

洁净室的通风系统消耗了大量的能源，尤其是通风扇、夏季的降温和除湿，以及冬季的加热和蒸汽加湿。因此，不断出现关于是否能在晚上或者不使用时为了节约能源而关闭房间通风系统的问题。

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.

不建议完全关闭通风系统，甚至建议别做这件事。设施、压力状态、微生物，在此期间所有的事情都可能脱离控制。它会使随后的恢复GMP合规状态的措施变得非常复杂，因为每次都需要再确认，以达到正常的GMP合规状态。

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 tousing the clean room again and this procedure must be validated.

但是降低通风系统的性能（通过减少通风系统的性能降低风量）是可能的，在某些企业已经实施了。然而，这也需要在再次使用洁净室之前必须达到GMP合规状态并且该程序也必须经过验证。

For this purpose the following points must  be observed:

为了该目标，需要注意以下几点：

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.

降低通风系统的性能也只能适可而止，因为要在整体上不能违反相关案例中洁净室的具体限值。必须在每个案例中针对操作状态和降低模式定义这些限值，包括允许的最小值和最大值，例如洁净室等级（相关颗粒粒径的颗粒计数），产品特定值（温度、相对湿度），压力条件（不同房间的压差）。注意，降低模式中的限值必须以这样的方式进行选择，也就是在生产开始前（结合时间计划）厂房必须达到GMP合规状态。该状态取决于不同的参数，例如建筑材料和系统性能等。压力状态应该时刻维持，这表示不允许气流方向的改变。

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.

此外，建议安装一个独立的洁净室的监控系统以防意外，目的是持续监控并记录上文提到的特定的洁净室参数。因此，相关的区域状态在任何时候都能被监控并记录。如果发生偏差（到达某一限值）以及单独案例中，可能接触到评估策略和通风系统的控制策略，并实施相关的调整。

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.

在降低通风性能时，应关注确保没有非预期的外部干扰，例如允许人员进入。对这种情况，就建议使用一个相应的门禁控制。在电子门禁系统中，进入权限是与之前提到的时间程序以及独立的洁净室监控系统相关联，这样，只有授权才能进入，以便符合预定要求。

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 cleanroom 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 directionare possible, for instance.

原则上，必须首先确认上述状态，然后在正常间隔进行再确认，通常对正常运行状态进行测量，例如设备完全失效情况下的恢复时间测量是必须执行的。在洁净室监控系统存在的情况下，如果程序已经过验证，原则不需要（如上所述）在降低模式后，操作开始时，实施进一步的测量。需要特别关注重新启动的规程，因为气流流动方向临时逆向是可能的。

All in all about 30 % of the energy costs can be saved depending on the mode of operation and the shift model but additionalinvestment costs might have to be offset.

总之，依靠运行模式的转换，能节省30%的能源消耗，但是可能被额外投资费用所抵消。

注：翻译仅供参考，请以英文为准。

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