DiveSafe Mouthpiece Test Results
Don't take our word for it. Our patent pending design was tested at one of the most reputable independent labs. Read the full report below, or download a PDF of the report here.
FINAL REPORT
Standard Method for Determining the Activity of Incorporated Antimicrobial Agent(s) In Polymeric or Hydrophobic Material
PROTOCOL: ASTM E 2180 ORDER NO: 030735622
PREPARED FOR: Andrew Powell
SUBMITTED BY: EMSL ANALYTICAL, INC.
307 West 38th Street New York, New York 10018 212.290.0051
EMSL Analytical, Inc. Microbiology Special Projects Division
307 West 38th Street New York, New York 10018 212.290.0051
Certificate of Analysis
Client: Casco Bay Molding, LTD
Contact: Andrew Powell
Project: ASTM E2180—Standard Method for Determining the Activity of Incorporated Antimicrobial Agent(s) In Polymeric or Hydrophobic Material
Product: Silicone Mouthpieces
EMSL NO: 030735622
Sample received: 10/19/2007
Start date: 11/01/2007
Completion Date: 11/05/2007
Experimental Summary:
Two samples were received by the laboratory for testing: one non-antimicrobial silicone mouthpiece and one test silicone mouthpiece (80/20; 3.5%). The ASTM method E2180 was performed, which is the method used “to evaluate (quantitatively) the effectiveness of agents incorporated or bound into or onto mainly flat (two dimensional) hydrophobic or polymeric surfaces” (Test Method E2180, pg1). The test organisms utilized were Staphylococcus aureus ATCC 6538 and Pseudomonas aeruginosa ATCC 15442. Two separate agar slurries were prepared, one for each organism. The agar slurries contained 1 mL of the test organism (concentration= 7.0x108 cells/mL), 0.85 g NaCl, 0.3 g agar, and 100 mL of deionized water. The final inoculum concentration was equal to ~7.0x106 cells/mL.
The control sample was prepared in triplicate and aseptically cut into twelve equally sized pieces. One mL of each agar slurry was applied to the prepared samples. Using both sonication and manual vortexing the agar slurry was immediately removed from one set of the control samples and plate counts were performed. The data recovered was designated ‘0 hours’.
The remaining set of control samples and the treated material were incubated at 35°C for 24 hours with the solidified agar slurry intact. The agar slurry was again removed and processed with sonication and vortexing. Plate counts were performed. The data retrieved from this set of samples was designated ‘24 hours’.
Calculation of ‘percent reduction’ compares the geometric mean of each time point data set with that of the relevant time point control.
Experimental Results:
Table 1.1—Colony forming units (CFU) collected after control and test mouthpieces were exposed to Pseudomonas aeruginosa and Staphylococcus aureus. Colony forming units are based on the average of three plate counts.
| Sample Identification | Contact Time ‘0 Hours’ | Contact Time ‘24 Hours’ | Percent Reduction | ||||
|---|---|---|---|---|---|---|---|
| P. aeruginosa CFU/mL | S. aureus CFU/ mL | P. aeruginosa CFU/ mL | S. aureus CFU/ mL | P. aeruginosa | S. aureus | ||
| Control | Avg | 4,080,000 | 3,700,000 | 86,300,000 | 66,000,000 | ||
| GM | 1,860,000 | 3,230,000 | 81,200,000 | 54,900,000 | |||
| Sample 1 | Avg | 10,500,000 | 67,600 | 91.2% | 99.9% | ||
| (80/20) | GM | 7,070,000 | 53,700 | ||||
Avg: Average of the three triplicate values
GM: Geometric Mean of the three triplicate values (used to calculate Percent Reduction)
Table 1.2—Raw data for triplicate counts for both samples, at 2 time points, inoculated with Pseudomonas aeruginosa and Staphylococcus aureus. (CFU/mL)
| Sample Identification | Contact time ‘0 Hours’ | Contact Time ‘24 Hours’ | ||
|---|---|---|---|---|
| P. aeruginosa CFU/ mL | S. aureus CFU/ mL | P. aeruginosa CFU/ mL | S. aureus CFU/ mL | |
| 930,000 | 6,400,000 | 123,000,000 | 92,000,000 | |
| Control | 10,600,000 | 2,300,000 | 74,000,000 | 83,000,000 |
| 720,000 | 2,400,000 | 62,000,000 | 23,000,000 | |
| 7,200,000 | 98,000 | |||
| Sample 1 (80/20) | 22,000,000 | 19,000 | ||
| 2,400,000 | 86,000 | |||
Download a PDF of this test report here.