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夜晚需不需求 封锁 GMP污染 车间

清洁 室的透风 系统 泯灭严重 动力 ,特殊 是透风 系统 的风扇、炎天 致冷和除湿以及冬天加热和加湿用蒸汽。是以 ,不时 就有这个效果 :公司能否 可以在早晨 或无须 的时间 封锁 房间的透风 ,以浪费 动力 ?

清洁
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?

污染 工程公司工程师一样往常 不建议完全封锁 透风 系统 ,设备 、压力条件、微生物,在此时代 一切 工具都市不受控制。这会让之后的恢复GMP切合形状 所需的措施很是严重 ,因为 每次都要做再确认,离开 达正常的GMP切合形状 。

一些公司经过 镌汰 透风 系统 的功率来镌汰 换宇量 ,降低透风 系统 的功率,可是 ,在重新运用 清洁 室之前照旧必需 抵达 GMP切合形状 ,而且该法式必需 经由 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 revalsidation 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.

为此小编必需 提示 注重 :

降低透风 系统 的功率只能抵达 一定水平 ,因为 要保险 总体来说不违犯 相关案例中清洁 室指定限制 。在每个案例中,这些运转 形状 下的和降低功率形状 下的限制 必需 界说,其中征求 允许最小和最大值。注重 ,在降低功率的形式 下的值的选择必需 使得设备 在消费 最先 之前的划准时 间内抵达 GMP切合形状 。

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.

医疗清洁
室

尚有 ,建议安设 一个自力 的清洁 室监测系统 ,这样可以一连 监测并纪录上述清洁 室指定参数。这样,所关注的区域的条件应可以在任何时间 举行 监测和纪录。

在降低风机功率时,要注重 确保没有非预期的外来滋扰浸染 ,例如职员 进入。这种情形 建议运用 照应 的职员 收支控制。若是 运用 的是电子锁系统 ,收支权限可以与上述时间 妄想 相关联,以及与自力 的清洁 室监测系统 相关联,这样,收支授权 必需 要切合预定的要求。

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.

清洁
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准绳 下去 说,两种形状 都必需 先确认,然后举行 活期 再确认。通常,通例运转 形状 下的丈量,例如装备 完全失效 情形下恢复时间 丈量是必需 要举行 的。若是 存在有清洁 室监测系统 ,法式经由 验证的话,准绳 上不需求 ---如上所述---在降低透风 功率后重新最先 运转 时举行 进一步丈量。特殊 要注重 的是重新最先 运转 时的法式,因为 ,好比气流倾向 短时逆向是有能够 发作 的。

总体来说,凭证 运转 形式 和当班形式 的分别 ,或许能浪费 30%左右的动力 ,但能够 会被特另外 投资本钱 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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