BIOBALL^® Burkholderia cepacia Complex Strains Performance Testing for USP <60> Growth Promotion Requirements

Over the years, presence of objectionable microorganisms has been identified as the leading cause of non-sterile drug product recalls in the U.S. Burkholderia cepacia is one of the most prominent objectionable microorganisms. 

USP <60> Microbiological Examination of Non-sterile Products – Tests for Burkholderia cepacia complex was officialised in December 2019 in the second supplement to USP 42/NF 37 and illustrates mandatory testing of aqueous based non-sterile products for the absence of Bcc test strains, i.e. B. cepacia, B. cenocepacia and B. multivorans. All 3 test strains are required for growth-promoting and indicative properties testing of Burkholderia cepacia selective agar (BCSA) and method suitability testing, as described in the chapter.

This white paper provides an evaluation of BIOBALL^® MultiShot 550 Bcc range recovery levels on bioMérieux BCSA (Ref 33631) ensuring they are acceptable as per growth promotion and indicative properties testing requirements of USP <60 > chapter.

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