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TEST METHOD
Sterility Test
USP <71> Sterility Test is a United States Pharmacopeia method used to test pharmaceutical products and other sterile articles for the presence of viable microorganisms. The test detects aerobic and anaerobic bacteria, yeasts, and molds (fungi) under specified test conditions. A satisfactory result is indicated by no evidence of microbial growth during the specified incubation period.
The infographic below provides a brief overview of the USP <71> test method.
Understanding USP <71> Testing
Application areas
USP <71> is used to evaluate the sterility of pharmaceutical products and other products that are required to be sterile.
The test may be applied to sterile products such as:
- Sterile pharmaceutical preparations
- Sterile medical products and articles
- Other applicable sterile products requiring sterility testing
The appropriate test method is selected based on the characteristics of the product and its suitability for membrane filtration or direct inoculation.
Test Microorganisms
USP <71> is designed to detect viable microorganisms that may be present in the test product, including:
- Aerobic bacteria
- Anaerobic bacteria
- Yeasts
- Molds (fungi)
Suitable culture media and specified incubation conditions are used to support the detection of microbial growth during the test.
Test Protocol
Step 1: Prepare the Test Product
The customer product is prepared under aseptic conditions to minimize the risk of contamination during the sterility test.
Step 2: Test the Product
The product is tested using either the membrane filtration or direct inoculation method, depending on the characteristics of the product and the applicable USP <71> requirements.
Step 3: Incubate the Culture Media
The appropriate culture media are inoculated and incubated under specified conditions for not less than 14 days to allow the detection of microbial growth.
Step 4: Examine for Microbial Growth
The culture media are examined at specified intervals and at the end of the incubation period for evidence of microbial growth.
Acceptance Criteria
The product complies with the sterility test when no evidence of microbial growth is observed in the test media during the specified incubation period, subject to the applicable USP <71> requirements and test controls.
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