Study on Preparation Methods of Bacterial Solution in Liquid Bacterial Retention Test
Objective:To study the application effect of frozen quantitative challenge liquid in the test of liquid bacterial retention in 0.22μm debacterialized drug liquid filter,the vitality of frozen quantitative Brevundimonas diminuta solution stored at-70˚C for different time was tested.Methods:In order to evaluate the activity of brevundimonas diminuta in the frozen quantitative challenge solution,the frozen quantitative challenge solution at different storage time points was quantitatively analyzed by dilution plate counting method.The liquid bacteria interception test was conducted.At the same time,the fresh quantitative challenge solution and the frozen counterparts were used for liquid bacteria interception test,and the consistency of the test results of the two different quantitative challenge solutions was compared.Results:There was no significant difference in the results of the frozen challenge liquid Brevundimonas diminuta stored at-70˚C for 2,4,6,8,10 and 12 months,respectively,compared with the logarithmic value of the colony counting at 0 month (P>0.05).The fresh quantitative challenge solution and the frozen counterparts were used for liquid bacterial interception test,and the detection results of the two quantitative challenge solutions were consistent.Conclusion:The frozen quantitative challenge liquid can be stably stored for 12 months at-70˚C,and the frozen quantitative challenge liquid Brevundimonas diminuta can maintain good vitality.The frozen quantitative challenge liquid can replace the fresh one.It can be applied to the test of liquid bacterial retention in 0.22μm debacterialized drug liquid filter,and the detection efficiency can be improved under the premise of ensuring the accuracy of the results.
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