Laboratory Report 160297-203

Antimicrobial Preservatives Effectiveness Evaluation of One Product When Challenged with Five Microorganism Species

SPONSOR
Prevent-Plus, LLC, 4240 Duncan Avenue, Suite 200, St. Louis, Missouri 63110

TESTING FACILITY
BioScience Laboratories, Inc., 1755 South 19th Avenue, Bozeman, Montana 59718

STUDY INITIATION DATE: 06/30/2016
STUDY COMPLETION DATE: 09/26/2016

This study evaluated the effectiveness of the Test Product to protect itself from microbiological (bacteria and fungi) contamination when challenged with five microorganism species specified in the United States Pharmacopoeia (USP 38, NF 33, 2015), Microbiological Test <51> Antimicrobial Effectiveness Testing: Aspergillus brasiliensis (ATCC #16404), Candida albicans (ATCC #10231), Escherichia coli (ATCC #8739), Pseudomonas aeruginosa (ATCC #9027), and Staphylococcus aureus (ATCC #6538). The effectiveness of the Test Product to protect itself from microbial contamination was evaluated at 14 and 28 days following inoculation with each of the five microorganism species.

The Antimicrobial Effectiveness Test is designed to detect growth of bacteria and fungus, which may have been introduced during or subsequent to the manufacturing process in a product that has been inoculated a single time with a minimum of 1 x 106 CFU/mL of bacteria or fungi listed in the United States Pharmacopoeia (USP 38, NF 33, 2015), Microbiological Test <51> Antimicrobial Effectiveness Testing. The product is then sampled at 14 and 28 days post inoculation to evaluate microbial presence.

The Test Product, Elastic Skin/Liquid Skin (Lot Number B0802A) met the criteria of this test, such that the bacteria Escherichia coli (ATCC #8739), Pseudomonas aeruginosa (ATCC #9027), and Staphylococcus aureus (ATCC #6538)] added to the Test Product on Day 0 of the Antimicrobial Effectiveness Test were reduced at least 2.0 log10 at Day 14 from the initial count of bacteria, and that at Day 28, there was no increase in the population of the bacteria from the Day 14 counts. Additionally, for the yeast and mold, Candida albicans (A TCC # 10231) and Aspergillus brasiliensis (ATCC #16404), there was no increase from the initial counts at Day 14 and Day 28. This indicates that under the conditions of this Antimicrobial Effectiveness Test, ingredients in the Test Product possess antimicrobial activity and were able to reduce and maintain the level of inoculum introduced to the Test Product for at least 28 days.

The Test Product, Elastic Skin/Liquid Skin (Lot Number B0802A), met the requirements of United States Pharmacopoeia (USP 38, NF 33, 2015) Microbiological Test <51> Antimicrobial Effectiveness Testing by reducing the population of Candida albicans by more than 5.0 log10 (99.99%), by reducing the populations of Escherichia coli, Pseudomonas aeruginosa and Staphylococcus aureus by more than 4.0 log10 (99.99%), and by reducing the population of Aspergillus brasiliensis by more than 3.9 log10 (99.98%) following exposure to the Test Product for 14 days and by preventing the increase of all of the microorganisms after 28 days of exposure.

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