PRESERVATIVES


Table 4: Minimum percentage of Zemea needed to boost preservative efficacy. Gram-positive


Gram-negative


Phenoxyethanol-based preservatives Microcare PM3 (0.15%) Euxyl PE 9010 (0.25%) Meolone PE (0.3%)


Jeecide CAP-4 Optiphen (0.25%)


Natural preservatives Lexgard Natural (0.5%)


Dermosoft 688 ECO (0.1%) Geogard ULTRA (0.5%)


Gram-negative


Yeast


Mould Staphlyococcus aureus Escherichia coli Pseudomonas aeruginosa Candida albicans Aspergillus niger


2% 4% 2% 2%


* * *


2% 4% 2% 2%


* * *


2% 2% * *


* * *


*Preservative levels provided sufficient reduction to <1.00 CFU/g without addition of Zemea.


Test methods & organisms The challenge testing was conducted by Clinical Research Laboratories, Piscataway, NJ. The methods employed were CTFA Microbiology Guidelines, Section 20, M-3, A Method for Preservation Testing of Water Miscible Personal Care Products and USP 33, Section 61, Neutralization/Removal of Antimicrobial Activity.


Using the organisms listed in Table 3, the formulations were inoculated with approximately 1 x 106 of product, 1 x 105 of product, or 1 x 105 gram of product.


bacteria per gram yeast cells per gram mould spores per


The microbial count was measured at 1, 2 and 7 days to determine the


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survivability of the microorganisms in the preserved test formulations.


Acceptance criteria


In this type of testing, the preservative is considered effective in the sample examined if:  The concentrations of viable bacteria demonstrate no less than a 3 Log reduction (99.9%) from the initial count at 7 days, and no increase for the duration of the test period.


 The concentration of viable yeast and moulds demonstrate no less than a


Results Table 4 shows the minimum percentage of bio-derived propanediol needed to boost the preservatives efficacy when used at one-half their recommended use level. These percentages are based on the concentrations of viable bacteria and yeasts reduced to <1.00 CFU/g at Day 7, and concentrations of viable moulds with a 1 Log reduction at Day 7.


1 Log reduction (90.0%) from the initial count at 7 days, and no increase for the duration of the test period.


4% 6% 6% 6%


*


2% 2%


2% (1 Log reduction) 2% (1 Log reduction) 2% (1 Log reduction) 2% (1 Log reduction)


2% (1 Log reduction) 2% (1 Log reduction) 2% (1 Log reduction)


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