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夜晚需不需要关闭GMP净化车间

  洁净室的通风系统耗费巨大能源,特别是通风系统的风扇、夏天致冷和除湿以及冬天加热和加湿用蒸汽。因此,一直就有这个问题:公司是否可以在晚上或不用的时候关闭房间的通风,以节约能源?

洁净室

  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?

  净化工程公司工程师一般不建议完全关闭通风系统,设施、压力条件、微生物,在此期间所有东西都会不受控制。这会让之后的恢复GMP符合状态所需的措施非常复杂,因为每次都要做再确认,来达到正常的GMP符合状态。

  一些公司通过减少通风系统的功率来减少换气量,降低通风系统的功率,但是,在重新使用洁净室之前还是必须达到GMP符合状态,并且该程序必须经过验证。

  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.

  为此小编必须提醒注意:

  降低通风系统的功率只能达到一定程度,因为要保证总体来说不违背相关案例中洁净室指定限度。在每个案例中,这些运行状态下的和降低功率状态下的限度必须定义,其中包括允许最小和最大值。注意,在降低功率的模式下的值的选择必须使得设施在生产开始之前的规定时间内达到GMP符合状态。

  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.

医疗洁净室

  还有,建议安装一个独立的洁净室监测系统,这样可以连续监测并记录上述洁净室指定参数。这样,所关注的区域的条件应可以在任何时间进行监测和记录。

  在降低风机功率时,要注意确保没有非预期的外来干扰影响,例如人员进入。这种情况建议使用相应的人员出入控制。如果使用的是电子锁系统,出入权限可以与上述时间计划相关联,以及与独立的洁净室监测系统相关联,这样,出入授权必须要符合预定的要求。

  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.

洁净室

  原则上来说,两种状态都必须先确认,然后进行定期再确认。通常,常规运行状态下的测量,例如设备完全失效情形下恢复时间测量是必须要进行的。如果存在有洁净室监测系统,程序经过验证的话,原则上不需要---如上所述---在降低通风功率后重新开始运行时进行进一步测量。特别要注意的是重新开始运行时的程序,因为,比如气流方向短时逆向是有可能发生的。

  总体来说,根据运行模式和当班模式的不同,大概能节约30%左右的能源,但可能会被额外的投资成本所抵消。

  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.


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