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TEST METHOD
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, cosmetics, and other applicable products. The test is a qualitative microbial examination used to detect specified microorganisms that may pose a risk to product safety and quality.
The microorganisms tested may include Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Salmonella spp., Clostridium spp., Candida albicans, and Gram-negative bacteria such as Pluralibacter gergoviae.
The infographic below provides a brief overview of the USP <62> test method.
Understanding USP <62> Testing
Application areas
USP <62> is used to detect specified microorganisms in nonsterile products where the presence of particular microorganisms needs to be assessed.
The test may be applied to:
- Nonsterile pharmaceutical products
- Pharmaceutical raw materials
- Cosmetics and personal care products
- Other applicable nonsterile products requiring specified microorganism testing
The microorganisms selected for testing depend on the product characteristics, intended use, and applicable requirements.
Test Microorganisms
USP <62> includes tests for specified microorganisms that may be relevant to product safety and quality, including:
- Staphylococcus aureus
- Pseudomonas aeruginosa
- Escherichia coli
- Salmonella spp.
- Clostridium spp.
- Candida albicans
- Bile-tolerant Gram-negative bacteria (e.g., Pluralibacter gergoviae)
The specific microorganisms tested depend on the applicable USP <62> requirements and the product being evaluated.
Test Protocol
Step 1: Prepare the Test Product
The customer product is prepared and diluted using a suitable sterile diluent according to its characteristics.
Step 2: Enrich the Test Sample
The prepared product is inoculated into suitable enrichment media and incubated under specified conditions to promote the recovery of the target microorganism, if present.
Step 3: Isolate the Target Microorganism
Following enrichment, aliquots of the culture are subcultured onto suitable selective or differential agar media. The agar plates are then incubated under specified conditions to support the detection of the target microorganism.
Step 4: Examine the Results
Following incubation, the agar plates are examined for characteristic colony growth associated with the target microorganism.
Where required, suspected colonies may be subjected to further identification or confirmation according to the applicable test procedure.
Acceptance Criteria
The product complies with the applicable USP <62> requirement when the specified microorganism is not detected in the quantity of product tested, subject to the applicable test procedure and confirmation requirements.
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