洁净室形成霉菌的湿度条件参考(中英文)

洁净室形成霉菌的湿度条件参考(中英文)

Normally, the maximum humidity in a pharmaceutical clean room is supposed to lie below 70% to prevent the formation of moulds.

通常，制药洁净室的最大湿度应为70%以下以避免霉菌产生。

In the GMP measuring point list, the humidity sensor is usually defined with an alert limit at 60% and an action limit at 70%.

对于GMP监测点，湿度探头通常设置警戒限为60%，行动限为70%。

A real risk of formation of moulds only exists if elevated humidity values occur over a longer period of time. Different values for this can be found in literature, like more than three hours a day with a surface humidity of 60-100% (in German language), for example.

只有长时间相对湿度较高才有形成霉菌的风险。这可以在文献中找到，如每天超过3小时表面湿度达到60%-100%。

According to DIN report 4108-8 (prevention of mould growth in residential buildings), mould formation occurs if the relative humidity of a surface reaches a value of more than 80% for at least twelve hours a day on at least five consecutive days.

根据DIN报告4108-8（住房预防霉菌生长），如果表面的相对湿度每天至少有12小时超过80%并持续5天，将会生长霉菌。

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