Our USP Microbial Testing service provides standardized microbiological evaluation in accordance with USP <61> Microbial Examination of Nonsterile Products. This testing evaluates the microbiological quality of products by measuring aerobic microbial counts and yeast and mold levels, which are key indicators of product safety and quality.
Manufacturers rely on microbial examination testing to confirm that products meet pharmacopeial expectations before release. Because microbiological quality directly affects consumer safety and shelf life, routine testing plays an essential role in quality programs.
USP <61> describes validated methods used to enumerate microorganisms present in nonsterile products. Quality teams and regulators use this data to verify that microbial levels remain within acceptable limits throughout a product’s lifecycle.
The chapter is published and maintained by the United States Pharmacopeia, and it applies broadly to pharmaceuticals, cosmetics, and personal care products.
This microbial examination evaluates:
Aerobic Plate Count (APC) to quantify total aerobic microorganisms
Yeast and Mold Count (YMC) to detect fungal contamination
Controlled incubation and colony enumeration
Result interpretation aligned with USP <61> expectations
In addition, laboratories assess sample preparation and neutralization to ensure accurate recovery of microorganisms.
Microbiological quality testing is commonly performed on:
Cosmetic and personal care products
Nonsterile pharmaceutical products
Raw materials and bulk ingredients
Creams, lotions, gels, liquids, and powders
Because microbial contamination can compromise safety and stability, testing supports both product release and ongoing quality monitoring.
Pentyl Labs delivers reliable microbiological testing aligned with USP <61> using clear reporting and practical turnaround times. Moreover, we support broader microbiology programs, including preservative efficacy testing and microbial limits evaluations. Therefore, results integrate smoothly into regulatory submissions and quality systems.
📩 Contact [email protected] to request USP Microbial Testing.