USP42<60> 非无菌产品微生物测试—BCC洋葱伯克霍氏菌测试

The tests described in this chapter will allow determination of the absence of Burkholderia cepacia complex (Bcc), which can be detected under the conditionsdescribed.
The tests are designed to determine whether a substance or preparation complies with an established specification for microbiological quality and/or to evaluatewhether products-especially those for inhalation use or aqueous preparations for oral, oromucosal, cutaneous, or nasal use-contain members of the Bcc.
GROWTH-PROMOTING AND INHIBITORY PROPERTIES OF THE MEDIA AND SUITABILITY OF TESTS FOR ABSENCE OF BCC
Test each batch of ready-prepared medium and each batch of medium prepared from either dehydrated medium or ingredients.
Preparation of Test Strains
Use standardized stable suspensions of test strains (see Table 1) NMT 5 passages removed from the original strain culture.