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The correct United States Pharmacopeia microbiology method depends on the product category, matrix, microbiological specification and question the testing needs to answer.
In practical terms:
| Question | Method Area |
|---|---|
| How much microbial growth is present in an applicable nonsterile product? | USP <61> |
| Is a specified microorganism present in an applicable nonsterile product? | USP <62> |
| What is the microbial count in an applicable nutritional or dietary supplement? | USP <2021> |
| Are specified microorganisms detected in an applicable nutritional or dietary supplement? | USP <2022> |
PBR provides applicable testing using these methods for relevant matrices.
Enumeration methods measure microbial populations.
Specified-microorganism methods evaluate the submitted sample for particular organisms.
These tests answer different questions and may both form part of a microbiological specification.
Powders, botanicals, capsules, tablets and liquids can behave differently during microbiological testing.
The method should therefore match the product and applicable specification.
Choosing a method only because another company or product uses it.
The correct question is:
Which method aligns with this product's specification and testing objective?
Before submitting samples, identify:
Ask PBR which United States Pharmacopeia microbiology method is appropriate for your matrix.