USP <60>

Microbiological Examination of Nonsterile Products – Tests for Burkholderia Cepacia Complex

The objective is to determine the presence or absence of the aerobic Burkholderia cepacia complex (Bcc) of microorganisms.

Method Suitability

The ability of the test to detect the specified microorganisms in the presence of product must be established.  Suitability is generally a one-time test but must be confirmed if a change in the product may affect the outcome of the test is introduced.  Method suitability is performed by inoculating the sample with a quantity of each specified microorganism of interest individually.  The acceptance criteria requires detection of the specified organism.  If the acceptance criterion is not met, it may be due to inherent antimicrobial properties of the sample that needs to be neutralized.

Minimum Sample Quantity Required

Unless otherwise directed in the monograph, 1 mL or 1g of material is to be tested.  An ideal submission would be 50g on the first submission to include method suitability and 25g on subsequent submissions. 

Turn Around Time

The turnaround time for regularly submitted samples is 10 business days.  Expedited testing less than 5 days is not available due to the incubation time required to complete the test.  Turn-around time for method suitability generally can be completed in 10 business days but may be extended if the acceptance criteria are not met on the first pass.  Expedited testing must be pre-arranged.