洁净室环境监测用培养基贮存效期的验证及方法学确认

Validation of storage validity period for culture medium used in clean room environmental monitoring and methodology qualification

目的验证洁净室环境监测用培养基的贮存效期,同时对环境监测浮游菌、沉降菌及表面微生物检测方法进行确认。方法对连续3批次贮存0、90、120 d洁净室环境监测用胰酪大豆胨琼脂(Tryptose soya agar,TSA)培养皿和TSA(L-80)接触皿进行相应菌液适用性检查(包括促生长能力和无菌检查)验证试验;并对贮存120 d TSA培养皿和TSA(L-80)接触皿分别进行环境浮游菌和沉降菌、表面微生物最长采样时间检测,然后再进行促生长能力测试。结果 TSA培养皿和TSA(L-80)接触皿贮存120 d (2～8℃90 d,25℃30 d)的适用性检查结果均符合《中国药典》2015版(三部)对培养基质量控制的要求。贮存120 d TSA培养皿进行洁净室环境浮游菌(主动采样10 min)、沉降菌(暴露采样4 h),以及TSA(L-80)接触皿进行表面微生物(接触采样10 s)检测后均具有良好的促生长能力。结论通过验证试验,确定了环境监测用TSA培养皿和TSA(L-80)接触皿的贮存效期120 d(2～8℃90 d,25℃30 d),并确认了贮存后TSA培养皿进行洁净室环境浮游菌、沉降菌检测的有效性,以及TSA(L-80)接触皿进行表面微生物检测的有效性。

Objective To validate the storage validity period of the culture medium plates for clean room environmental monitoring,and to confirm the environmental monitoring detection methods of volumetric sampling,settling plates and surface microorganism. Methods The applicability examination was performed including growth promotion and aseptic test by using of tryptose soya agar（ TSA） culture plates and TSA（ L-80） contact plates which were stored 0,90,120 d. The longest sampling time of volumetric sampling,settling plates and surface microorganism were tested by both types of plates stored 120 d,and then the growth promotion was tested. Results The applicability examination results of TSA and TSA（ L-80） plates stored 120 d（ 2～8 ℃ 90 d,25 ℃ 30 d） met requirement on the quality control of the culture medium in《ChinesePharmacopoeia》volume Ⅲ,2015 edition. These had good growth promoting ability for the TSA and TSA（ L-80）plates stored 120 d for clean room environmental monitoring tests including volumetric sampling（ active sampling 10 min）,settling plates（ exposure sampling 4 h） and surface microorganism（ contact sampling 10 s）. Conclusion The storage validity period of the both types of plates was 120 d（ 2 ～ 8 ℃ 90 d,25 ℃ 30 d） for environmental monitoring. It was confirmed that the effect of the TSA culture plates after storage in test of volumetric sampling,settling plates in the clean room,and the effect of the TSA（ L-80） contact plates in test of surface microorganism.