中国药典微生物检测翻译稿AppendixXIJMicrobialLimitTestMetho.docVIP

Appendix XI J Microbial Limit Test Method The tests for microbial limit are designed for non-sterile products and their APIs, excipients to determine the microbial contamination, including tests for bacteria count, mold count and the test for specified micro-organisms. The microbial limit test should be performed in the 100-Class clean area with one-direction air flow introduced in, which settled in the 10000-Class clean environment. And all the tests should strictly comply with sterile technique to protect recontamination. The cleanliness of the one-direction air flow area, working bench and the environment should be validated based upon current national criteria on Test Method for Airborne Particles, Airborne Microbe and Settling Microbe in Clean Room (area) of the Pharmaceutical Industry regularly. If the substances to be examined have surface-active agents, neutralizing agents or inactivators, their efficacy and absence of influence for micro-organisms must be demonstrated. The culturing temperature for bacteria is 30~35?C; for molds and yeasts 23~28?C; and for specified micro-organisms 35~37?C, unless otherwise prescribed. The results should be reported in 1g, 1ml, 10g, 10ml or 10cm2. Test Amount Test amount is the amount of the sample to be examined once (in g, ml or cm2). The test amount is normally 10g or 10ml, unless otherwise prescribed for chemical films 100 cm2; for expensive or micro-packaged drugs, reduced test amount is acceptable. The sample to be examined for Salmonella another 10g or 10ml is required. While testing, sample from more than 2 minimum packages, for films at least 4 sheets. Generally speaking, randomly sample 3 times of the test amount (more than two minimum packages). Preparation of Test Solution The suitable method for test solution preparation depends upon the physical and biological characteristics of the substance. If the preparation introduces water bath for heating, the temperature shouldn’t exceed 45?C. As soon as the test