27th October 2021 Content supplied by: bioMérieux (Industry)
Manage your USP <60> Testing Needs Using a Reliable and Robust Certified Reference Material
BIOBALL® MultiShot 550 Bcc range : Growth Promotion Testing of Burkholderia cepecia selective agar (BCSA)
USP <60> Microbiological Examination of Non-sterile Products – Tests for Burkholderia cepacia complex 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 tests trains are required for growth promoting and indicative properties testing of BCSA and method suitability testing, as described in the chapter.
BIOBALL MultiShot 550 Bcc range consists of B. cepacia NCTC 10743 (Ref 416589), B. cenocepacia NCTC 13227 (Ref 423580) and B. multivorans NCTC 13007 (Ref 423581), and is used with Alternative Re-Hydration Fluid (Ref 417843) which is specifically designed to enhance BIOBALL recovery on a highly selective media such as BCSA.
All BIOBALL Bcc range batches tested on multiple batches of BCSA (bioMerieux Ref 33631) showed comparable growth of microorganisms and all recovery rates were within 50 to 200% of the mean count reported on batch-specific certificate of analysis. BIOBALL, being a quantitative Certified Reference Material, ensures batch-to-batch consistency and strong reproducibility even on a culture media that may be highly selective in nature. This helps in significantly minimizing risk of QC failure, ensuring timely release of culture media and overall boosting user’s confidence in their culture media QC methods.
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Date Published: 27th October 2021
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