Verification of method for microbial limit test on diatomite and pearlite

VernacularTitle:血液制品生产用助滤剂微生物限度检查方法建立
Author: Qiming ZHANG ¹ ; Yali WANG ² ; Yonghao XU ¹ ; Lin ZHANG ¹ ; Congcong HAN ¹ ; Zhidong WANG ¹ ; Jipeng ZHANG ¹ ; Fujun YANG ¹ ; Xiao LIU ¹
Author Information

1. Lanzhou Lansheng Blood Products Co., Ltd., Lanzhou 730046, China
2. Gansu Justitute for Drug Control
Publication Type:Journal Article
Keywords: filter aid; methodology validation; microbial limit; blood products
From: Chinese Journal of Blood Transfusion 2021;34(10):1147-1149
CountryChina
Language:Chinese
Abstract: 【Objective】 To establish a microbial limit test method for diatomite and pearlite, and verify its applicability. 【Methods】 According to the requirements of general rule 1105, Microbial Limit Test for Non Sterile Products of Pharmacopoeia of the People′s Republic of China (2020 Edition), the applicability test of microbial counting methods for three batches of perlite and diatomite was conducted before the microbial limit test of samples. The microbial growth of filter aid was analyzed and the recovery rate of each test bacterium was calculated. 【Results】 The ratio of the colony number of the test group minus the colony number of the test sample control group to the bacterial liquid control group was in the range of 0.5~2.0. 【Conclusion】 The method is accurate, reliable and can be used for microbial limit test of diatomite and perlite.