TEST METHOD

USP <71>
USP <71>

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 diagram below summarizes the USP <71> test method.

 

TESTING CRITERIA AND CUSTOMER PROCESS

Step 1: What test methods are used?

Sterility testing is performed using membrane filtration or direct inoculation methods depending on the product type.

Step 2: How are samples tested?

The product is introduced into suitable culture media using either membrane filtration or direct inoculation.

Step 3: How long is the incubation period?

All test media are incubated for not less than 14 days under specified conditions to allow detection of microbial growth.

Step 4: How are results evaluated?

After incubation, test media are examined for evidence of microbial growth.

Step 5: What are the acceptance criteria?

The product complies with USP <71> when no evidence of microbial growth is observed after the incubation period.

Step 6: Place an order and send your sample to us

Fill in the test request form and place an order via email at info@tecolab-global.com. We will advise on the quantity of sample required for testing.

You can deliver the sample to us via courier or our sample delivery service and provide us the tracking code. We will monitor the delivery status and inform you when we receive the sample.

Step 7: Track the status of your request

Once we have received your sample, we will provide a tracking number to you. You can easily track the status of your request here.

Step 8: Download your password-protected test report

Download your readily available test report online with just a single click using the link and password provided via email notification. We will receive a notification once you have downloaded the test report.

For safety purposes, the uploaded test report will self-destruct after 7 days.