Validation of microbial limit test method of eleven hospital preparations

WEM Yu-hui; HAM Zhen-zhen

Abstract：Objective:To establish a method for the microbial limit test of 11 hospital preparations. Methods:A validation on the microbial limit test method was conducted in accordance with the counting method of bacteria,mycetes and yeasts,the control bacteria test method and the microbial limit test application guidelines stated in the appendix of china pharmacopoeia (2010 edition). Results:Of 11 varieties,there are six varieties which have antibacterial activity to hay bacillus,and whose bac-teria number can't be inspected according to conventional method. Among the six varieties,the three varieties which have wea-ker bacteriostatic action can breed bacterias whose number can't be inspected according to culture medium dilution method, and the other three varieties which have stronger bacteriostatic action can breed bacterias whose number can't be inspected ac-cording to membrane filtration method. And the other five varieties and items are available according to the onventional meth-od. Conclusion:Hospital preparations should undergo validation with the microbial limit test method to ensure the correctness of test results.