HQ841水凝胶树脂粉微生物限度检查方法验证

Validation of Microbial Limit Method of HQ841 Hydrogel Resin Powder

目的建立HQ841水凝胶树脂粉微生物限度检查法,并对方法进行验证。方法将供试品配制为1∶20的溶液,按常规法进行细菌数、霉菌和酵母菌数检查及控制菌(铜绿假单胞菌、金黄色葡萄球菌)的检查。结果在3次独立的平行试验中,细菌数、霉菌和酵母菌数检查方法的验证试验,5株试验菌回收率均>70%;控制菌测定中,检查铜绿假单胞菌和金黄色葡萄球菌,试验组均可检出试验菌。结论采用常规法进行HQ841水凝胶树脂粉细菌数、霉菌和酵母菌计数及控制菌检查,方法有效可行。

OBJECTIVE To establish a method for the microbial limit test of HQ841 hydrogel resin powder. METHODS The sample preparation of 1 ： 20 solution, bacteria, yeast and mold counts the number of inspection and control bacteria by conventional method （Pseudornonas aeruginosa, Staphylococcus aureus） examination. RESULTS In the parallel test of 3 independent, verification test bacteria, yeast and mold count number check method, 5 strains of tested bacteria recovery rate was 〉70%. The control bacteria examination determination, Pseudomonas aeruginosa and Staphylococcus aureus, the test group were detected bacteria, negative group are sterile growth, Gram-negative bacteria in the control group had no growth. CONCLUSION The method can be used in microbial limit test ofHQ841 hydrogel resin powder.