Are you ready for the new USP Chapter <60> B. cepacia guidelines?

by Randy Wolford, Microbiology Group Leader

Burkholderia cepacia is a gram-negative aerobic bacteria commonly found in soil and water. It is an opportunistic pathogen that has the ability to remain viable under harsh conditions as it is resistant to certain preservatives and antimicrobial agents. Pharmaceutical water systems are especially susceptible to contamination by these organisms. The prevalence of this organism in the manufacturing environment leads to the increased risk that finished drug products will be contaminated with B. cepacia.

In 2017, the FDA issued an advisory to drug manufacturers concerning the risk of contamination of non-sterile water based drug products with microorganisms from the Burkholderia cepacia complex (Bcc). This advisory was in response to drug product recalls regarding their contamination with B. cepacia. The FDA advised drug product manufacturers to establish scientifically sound and appropriate test procedures for detection of Bcc for both drug product components and finished drug products. There was no method for the detection of B. cepacia complex published in the compendia during this time.

In September 2018, the USP Pharm Forum 44(5) published a new proposed chapter titled, “USP <60> Microbiological Examination of Nonsterile Products - Tests for  Burkholderia cepacia Complex.” The chapter provided methodology and testing parameters for the detection of organisms in the B. cepacia complex. In June 2019, USP <60> was published in its final form with an effective date of December 1, 2019. Eurofins Lancaster Laboratories actively participated in the comment portion of this chapter and has established a new internal method to meet the requirements of USP <60>.

Contamination of finished drug products by B. cepacia complex will continue to be an area of increased scrutiny by the regulators. Eurofins Lancaster Laboratories is currently offering Bcc testing that is compliant with the USP. For additional information refer to the Eurofins Lancaster Laboratories Webinar “Bcc Testing for Water-based Drug Products is Coming-Get Ahead of the Game.”