USP 61 Microbial Enumeration Testing

TEST METHOD

USP <61> USP <61>

Quantitative enumeration of aerobic bacteria (TAMC) and fungi (TYMC) for non-sterile pharmaceutical products.

USP <61> is a United States Pharmacopeia method for the quantitative enumeration of viable aerobic bacteria (TAMC) and fungi (TYMC) in nonsterile pharmaceutical products. The test assesses the level of viable microorganisms present to support product quality, safety, and regulatory compliance.

The diagram below summarizes the USP <61> test method.

TESTING CRITERIA AND CUSTOMER PROCESS

Step 1: How is the sample prepared?

The sample is prepared using a suitable method based on its physical characteristics and in accordance with USP <61>.

Step 2: Which methods are used for enumeration?

Microbial enumeration may be performed using validated methods such as membrane filtration, plate count techniques, or the Most Probable Number (MPN) method.

Step 3: How are microorganisms enumerated?

Samples are processed using the selected method and incubated under appropriate conditions to allow microbial growth.

Step 4: How are results reported?

Results are reported as Total Aerobic Microbial Count (TAMC) and Total Yeasts and Moulds Count (TYMC).

Step 5: What are the acceptance criteria?

Acceptance criteria follow USP <1111> and applicable regulatory guidelines. Microbial limits vary depending on product category, route of administration, and intended use.

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.