生产新生化颗粒设备清洗方法探究实验

Cleaning Ways in Equipment for Xinshenghua Particles Preparation

目的:研究新生化颗粒生产设备的清洗方法。方法:按预定的清洗方法对生产3个批次新生化颗粒后的设备进行清洗,清洗后按要求在设备特殊部位擦拭取样,进行残留物和微生物检测。结果:擦拭取样的化学残留物检测结果为阴性,微生物限度<100 CFU/25 cm2。结论:擦拭取样的化学残留物和微生物限度均在现用的生物参考区间,预定的设备清洗方法符合新生化颗粒的生产要求。

Objective：To research the cleaning ways in equipment for Xinshenghua particles preparation. Method：The equipment which was used for preparation of 3 batches of Xinshenghua particles was cleaned. Samples of the privileged sites were taken,then residue and microorganisms of samples were detected. Result：The test for chemical residue was negative,microbial limit was 〈100 CFU/25 cm^2. Conclusion：Chemical residue and microbial limit of samples are within the biology reference interval being used.Predetermined cleaning ways in equipment for Xinshenghua particles preparation meet production requirements.