Do I have to perform a neutralization study on my product(s) before conducting an Antimicrobial Efficacy (AET) study?
- Posted by Mark Goins
- On January 31, 2018
If a drug, cosmetic, or health and beauty care product possesses antimicrobial properties due to the presence of a preservative or because its formulation creates natural preservative action, this antimicrobial property must be neutralized to recover viable microorganisms during the AET study. The ability of the AET procedure to detect challenge microorganisms in the presence of a suitably neutralized product to be tested must be established. In most cases the neutralization study only needs to be performed once per product type. A change in formulation may require an updated neutralization study.