USP 81 Antibiotics, Standard Method for Microbial Testing

EUROLAB laboratory provides testing and compliance service within the scope of USP 81 standard. The activity (potency) of antibiotics can be demonstrated by their inhibitory effects on microorganisms under suitable conditions.

A reduction in antimicrobial activity may not be adequately demonstrated by chemical methods. This section summarizes procedures for antibiotics recognized in the United States Pharmacopeia (USP), where microbiological assay is the standard analytical method.

Microbiology testing identifies the presence and type of microbes in the manufacturing environment, medical product, or medical device. Specific regulatory tests for microbiology may include tests such as microbial count testing, particle analysis, yeast analysis, antifungal activity assessment, growth promotion testing, microbial limit testing, zone of inhibition testing, water analysis, bacteriostasis fungus testing, bacteria identification, yeast identification.

Microbiology tests often require sampling from a product, a surface, a water source, or the air. After the samples are taken, various microbiology tests can be performed.

The potency of an antimicrobial agent can be demonstrated by its inhibitory effect on microorganisms. Because chemical methods can be unreliable, antimicrobial growth reduction is often tested using a microbiological inhibition zone test.

EUROLAB assists manufacturers with USP 81 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.