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Microbiological examination of nonsterile products: Tests for specified microorganisms
USP <62> is a United States Pharmacopeia test used for the detection of specified microorganisms in nonsterile pharmaceutical products, raw materials, and cosmetics. The test is a qualitative microbial examination used to detect specified objectionable microorganisms that may pose a risk to product safety and quality, including Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Salmonella spp., Clostridium spp., Candida albicans, and bile-tolerant Gram-negative bacteria such as Pluralibacter gergoviae.
The diagram below summarizes the USP <62> test method.
TESTING CRITERIA AND CUSTOMER PROCESS
Step 1: Which microorganisms are tested?
The method targets specified objectionable microorganisms, such as Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Salmonella spp., Candida albicans, bile-tolerant Gram-negative bacteria (e.g., Pluralibacter gergoviae), and other relevant organisms depending on product requirements.
Step 2: How is the sample prepared?
The sample is prepared in accordance with USP <61> and any applicable product-specific requirements prior to testing.
Step 3: What is the enrichment step?
The prepared sample is inoculated into suitable enrichment media to promote the recovery of target microorganisms, if present.
Step 4: How are microorganisms isolated?
Following enrichment, samples are transferred onto selective agar media to isolate and detect characteristic colonies.
Step 5: How are results evaluated?
Selective media are incubated under appropriate conditions and examined for characteristic microbial growth.
Step 6: What are the acceptance criteria?
The product complies with USP <62> when the specified microorganisms are absent from the tested sample.
Step 7: 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 8: 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 9: 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.