Comparative study of four methods for detecting microbial count recovery rate on sheet drug packaging materials
Objective:To establish a simple and practical microbiological counting method suitable for sheet drug packaging materials by comparing the results of four sampling methods.Methods:The samples of artificial con-tamination of sheet drug packaging materials were prepared by standard strain adding method.The surface micro-organisms were collected by wiping method prescribed by national drug packaging container(material)standard,as well as by self-designed washing method,direct inoculation method and contact dish method.The correspond-ing recovery rate was calculated.The results of 4 sampling methods were analyzed by one way analysis of variance(ANOVA).Results:From high to low,the recovery rate was as follows:contact dish method,direct inoculation method,wiping method and washing method.There were significant differences in the recovery rates of contact dish method,wiping method and washing method(P＜0.05).The recovery rate of contact dish method was slightly higher than that of direct inoculation method,but there was no significant difference between them(P＞0.05).There was no significant difference in the recoveries of medicinal film,aluminum foil and hard sheet among the four methods(P＞0.05).Conclusion:The contact dish method is simple,sensitive and accurate,and can be used for the examination of the microbial limit counting method of sheet drug packaging materials.
NETL
NSTL
万方数据
