USP 60 Burkholderia Cepacia Complex Testing

TEST METHOD

USP <60> USP <60>

Microbiological Examination of Nonsterile Products – Tests for Burkholderia Cepacia Complex

USP <60> is a United States Pharmacopeia standard used to detect Burkholderia cepacia complex (Bcc) in nonsterile pharmaceutical and personal care products. The test helps identify potentially objectionable microorganisms that may affect product safety and quality, supporting compliance with microbiological requirements.

The diagram below summarizes the USP <60> test method.

TESTING CRITERIA AND CUSTOMER PROCESS

Step 1: How is the sample prepared?

The sample is prepared and diluted according to USP <60> requirements to facilitate the detection of Burkholderia cepacia complex (Bcc).

Step 2: How is the sample enriched?

The sample is incubated in Soybean–Casein Digest Broth (SCD) at 30–35°C for 48–72 hours to promote the recovery of Bcc, if present.

Step 3: How is Bcc detected?

Enriched cultures are streaked onto Burkholderia cepacia Selective Agar (BCSA) and incubated at 30–35°C for 48–72 hours for selective detection.

Step 4: How are results evaluated?

The plates are examined for characteristic colonies of Burkholderia cepacia complex (Bcc).

Step 5: What are the acceptance criteria?

The product complies with USP <60> when no characteristic colonies of Burkholderia cepacia complex (Bcc) are observed on Burkholderia cepacia Selective Agar (BCSA).

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.