USP <62>

Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms

The objective is to determine the presence or absence of the aerobic microorganisms Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Salmonella, Candida albicans, the anaerobic microorganism Clostridium or bile tolerant gram-negative bacteria.

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.

Sample Quantity Required

For the first submission please submit 50g per organism to include method suitability.  Subsequent submissions please follow the table below.

Microorganism	Minimum Quantity Required	Requested Quantity
Staphylococcus aureus	1 mL or 1 g	25 mL or 25g
Pseudomonas aeruginosa	1 mL or 1 g	25 mL or 25g
Escherichia coli	1 mL or 1 g	25 mL or 25g
Salmonella	10 mL or 10g	50 mL or 50g
Candida albicans	1 mL or 1 g	25 mL or 25g
Clostridium	2 mL or 2 g	25 mL or 25g
Bile Tolerant Gram Negative Bacteria	1 mL or 1 g	25 mL or 25g

Turn Around Time

The turnaround time for regularly submitted samples 10 business days.  Expedited testing is available as presented in the Table below.  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.