Establishment and Methodology Validation of Microbial Limit Examination for Dilute Glutaral Solution

OBJECTIVE To establish a effective method for microbial limit test of dilute glutaraldehyde solution. METHODS The methodology validation experiment for dilute glutaraldehyde solution was conducted according to the microbial limit test in the appendix ⅪJ of Chinese pharmacopoeia (second part, 2010 Edition). RESULTS In microbial limit test of dilute glutaraldehyde solution, the culture medium dilution method was used for mould and yeast count, the membrane filtration method was used for bacterial count and the routine method for control the bacteria. CONCLUSION During this article, some certain methods should be fully considered to eliminate this dilute glutaraldehyde solution’s bacteriostasis before the experiment for microbial limit test of this medicine.