Total aerobic bacteria testing

Usually, total aerobic bacteria, molds, and yeasts are counted by using a standard plate count in order to test the microbial limits. The microbial limit test may be customized by performing a screening for the occurrence of Staphylococcus aureus, Pseudomonas aeruginosa, Pseudomonas cepacia, Escherichia coli, and Salmonella sp. [56],... 

Microbial limits. Acceptance criteria should be set for the total count of aerobic microorganisms, the total count of yeasts and molds, and the absence of specific objectionable bacteria. A decision tree is provided in the guideline to aid in deciding which would be appropriate microbial tests. 

Tests for microbial limits may also have to be considered depending on the nature of the API, its method of manufacture, and its intended use. Sterility testing may be appropriate for APIs that will be used in parenteral or oral solution products that are sterile. Endotoxin testing may be needed for APIs intended for injectable products. Testing for the total count of aerobic microorganisms, yeasts, and molds and the absence of specific objectionable bacteria, such as Staphylococ-cus aureus, Escherichia coli. Salmonella, and Pseudomonas aeruginosa, may also be required. The tests described in the various compendia are generally used. 

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