潔凈室形成霉菌的濕度條件參考(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,制藥潔凈室的最大濕度應(yīng)為70%以下以避免霉菌產(chǎn)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%.
潔凈室形成霉菌的濕度條件參考(中英文)” />
對于GMP監(jiān)測點,濕度探頭通常設(shè)置警戒限為60%,行動限為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.
只有長時間相對濕度較高才有形成霉菌的風(fēng)險。這可以在文獻中找到,如每天超過3小時表面濕度達到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.
根據(jù)DIN報告4108-8(住房預(yù)防霉菌生長),如果表面的相對濕度每天至少有12小時超過80%并持續(xù)5天,將會生長霉菌。
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