PET/USP 51 and USP 61/62
Need to Know if Your Product Passes FDA Specs for Cosmetics?
Before personal care products can go to market, they first must pass certain requirements. The FDA requires all cosmetic products to be free of pathogenic microorganisms before they can go to market. There are a number f tests that can be performed in order to pass FDA requirements.
USP 51 or Antimicrobial Effectiveness Testing (AET) is done if there are any preservatives added to the product in order to test how effectively the preservatives function. This is required to ensure that the product is unsuitable to microbial life. This analysis is generally done over a total of 28 days. The product is exposed to certain strains of bacteria and fungi, and then is checked for growth at dedicated intervals throughout the 28-day period. If there is an indication of abnormal growth in any of the strains the product is exposed to, then the product may need to be reformulated.
USP 61/62 analysis is performed to determine the microbial content of a sample. USP 61 includes both TAMC (Total Aerobic Microbial Count) and TYMC (Total combined Yeast & Mold Count). USP 62 is done in order to determine the presence or absence of specific unacceptable microorganisms. Some of these microorganisms include: S. aureus, P. aeruginosa, C. albicans, E. coli, and A. niger.
Suitability or Compatibility analysis is done to determine the shelf life of a product, establishing its antimicrobial properties, as well as to detect the interactions of the product with its packaging.
Suitability Testing is often done under several conditions in order to most accurately mimic real-life situations so as to determine shelf life.
Compatibility testing is necessary to detect the interactions of the product with its packaging, so as to ensure there are no quality problems and that the product doesn’t affect the package.
Enalytic is a full-service analytical laboratory. We take pride in going the extra mile working in concert with our clients to offer the best service at reasonable costs.
Our over 40 years of combined experience in the analytical field allows us to develop methods to fit your specific application and affords you the best opportunity for a solution to your problem.
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