洁净室霉菌污染，有哪些来源？.docxVIP

PAGE6 / NUMPAGES6 洁净室霉菌污染，有哪些来源？ 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 l