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Application note: BIOBALL® Burkholderia cepacia complex strains performance testing for USP <60> growth promotion requirements

Over the years, the presence of objectionable microorganisms has been identified as the leading cause of non-sterile drug product recalls in the US.

Over the years, the presence of objectionable microorganisms has been identified as the leading cause of non-sterile drug product recalls in the US. Burkholderia cepacia is one of the most prominent objectionable microorganisms associated with 102 non‑sterile drug recalls from 2012 to 2019. It is an opportunistic pathogen and has a distinctive ability to overcome antimicrobial preservative systems. Moreover, Burkholderia cepacia complex (Bcc) comprises of approximately 24 closely related species, which are widely found in the environment and have the ability to form biofilms in pharmaceutical water systems. More specifically, two members of the Bcc group, Burkholderia cenocepacia and Burkholderia multivorans account for >85 percent of cystitis fibrosis infections.