GMP洁净室的通风设备在晚上能否关闭

GMP洁净室的通风设备在晚上能否关闭

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。