Microbiology

USP 61 and 62: Microbial Enumeration Tests

Total aerobic and yeast/mold counts under USP <61>, and testing for specified and objectionable organisms under USP <62>.

What this course covers

This course covers total aerobic microbial count and total yeast and mold count testing under USP <61>, testing for specified and objectionable microorganisms under USP <62>, how acceptance criteria differ by product category and route of administration, and sample preparation and neutralization considerations that affect result validity.

Who this course is for

Microbiology laboratory staff performing enumeration testing
QA staff reviewing results against product-specific acceptance criteria

What you'll learn

Total aerobic microbial count and total yeast and mold count testing under USP <61>
Testing for specified and objectionable microorganisms under USP <62>
How acceptance criteria differ by product category and route of administration
Sample preparation and neutralization considerations that affect result validity
How USP <61> and <62> results feed into product release decisions

Why it matters

A test that fails to neutralize a product's antimicrobial preservative before plating will systematically under-report bioburden, potentially releasing a product that should have failed. Method validity is not a checkbox, it directly determines whether the result means anything.

Included in the full GMPify subscription

Completion certificate, PDF slide download, and access to the complete GMP course library from day one.

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