A distinct testing question
Sterility testing evaluates whether viable microorganisms grow under the prescribed culture conditions. It is different from counting the background microbial population in a nonsterile product. It also does not replace bacterial endotoxin testing.
Plan the product and units
Provide the dosage form, lot grouping, unit sizes and applicable specification. Keep the original units unopened. Product characteristics and the agreed scope determine the preparation and test approach.
Culture and reporting
The USP <71> culture pathway includes a 14-day incubation period. Reporting follows completion and review of the test. A rapid screen should not be described as the same compendial test.
When growth is observed
Identification of a recovered isolate can support follow-up work. Identification is a separately scoped service. A result applies to the tested units and conditions; it is not a guarantee about every unit in a lot.
Related testing & guidance
Technical & service references
Vanguard service detailsSource review: November 8, 2026. The agreed method and project scope govern the testing.