USP <60> Test for Burkholderia cepacia Complex

Get A Testing Quote

Testing for microorganism contamination is critical to ensure products are safe for consumer use. Testing at various stages of production is important to determine that a product isn’t contaminated during manufacture, assembly, or packaging.

The USP <60> Test for Burkholderia cepacia Complex, like the USP <61>, is a product safety test from the United States Pharmacopeia. The USP <60> test evaluates a product for the presence or absence of potential pathogens, specifically those in the Burkholderia cepacia Complex, a complex comprised of 20+ species of strong water-borne opportunistic pathogens. These can be resistant to antibiotics and remain viable even under extremely harsh manufacturing and processing conditions, and even lead to fatal complications for more vulnerable and susceptible groups of the population. USP <60> tests are necessary for cosmetic and personal products to determine the absence of Burkholderia cepacia Complex.

This test method has defined procedures for the detection of B. cepacia, B. cenocepacia, and B. multivorans.

Summary of the USP <60> Test

The USP <60> Test consists of an initial enrichment of the sample in an appropriate enrichment broth, and then streaking the enriched sample onto selective media for determination of the presence or absence of Burkholderia cepacia Complex. It utilizes specific elements of the USP <61> for sample preparation to include the neutralization of the product to be tested.

The USP <60> requires that prior to or in concert with routine specified microorganism testing, a one-time suitability of recovery test must be performed. This suitability test demonstrates the ability of the methods used to recover and detect the defined microorganisms if they are present in the sample.

Sources:

https://www.biopharma-reporter.com/Headlines/Promotional-Features/Notes-on-compliance-USP-60-compliance-doesn-t-have-to-be-complicated

https://journals.asm.org/doi/10.1128/CMR.00139-19