Antimicrobial Preservative Efficacy Testing

Antimicrobial Preservative Efficacy Testing

The majority of cosmetic products include, as part of the formulations, one or more ingredients intended to function as preservatives of product chemical and physical integrity, and toward that end, to prevent growth of microbial contaminants. 

For purposes of FDA approval, the effectiveness of the preservatives must be proven by testing that is performed according to the specifications of the U.S. Pharmacopeia Method 51, Antimicrobial Effectiveness Testing. Criteria for Category I products are for bacteria not less than a 1 log10 reduction from initial population at Day 7, not less than a 3 log10 reduction from initial population at Day 14, at Day 28, no increase from the count recorded at Day 14. For the fungi, the criterion is, on Days 7, 14, and 28 no increase in population from the initial population. Additionally, as determined by subjective observation, there must be no change in consistency or color of the product due to the bacterial or fungal contamination over the 28-day period of testing. 

 Antimicrobial effectiveness testing should be performed on all aqueous-based products that are injectable, ophthalmic, OTC, nasal, oral, and topical.

Labs
Methods
Industries

In-Vitro Laboratory

Scientists in our In-Vitro testing labs are well trained on ASTM, AATCC, AOAC, CLSI, and EN standard methods. The efficacy testing services of this laboratory include MIC/MBC, biofilm prevention and removal, time-kill kinetics, clean room disinfectant validation, zone of inhibition and custom efficacy studies for disinfectants, antimicrobials and other products requiring EPA registrations and FDA 510(k) submissions. Studies in…

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ASTM - E640

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PCPC 1

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USP 51

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Health Care Antiseptic

For over 25 years BioScience Laboratories has led the industry in Healthcare antimicrobial product testing. BSLI is a GLP, FDA and EPA audited and Contract Research Organization providing Phase I through IV clinical trials, as well as, in-vitro testing services. Put our extensive experience to work, we are eager to help.

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Cosmetic & Beauty Product Testing

BioScience Laboratories, Inc. (BSLI) offers comprehensive in-vitro and clinical cosmetic testing capabilities. BSLI performs human clinical evaluations performed for safety, efficacy and claims support of cosmetics, raw materials, toiletries, personal care, household and dermal OTC's. We specialize in customized studies to support product claims from moisturization, anti-aging, antiperspirant and acne to…

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Personal Care Products

We serve clients from around the world who contract us to perform investigative studies on a wide range of personal care products. Standard, validated protocols have been developed to substantiate a wide variety of personal care product claims as well as claims for prescription and over-the-counter drug products. Specialized testing for these…

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