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PREVENTION Ag

PREVENTION Ag. Silver Composite Materials: EH & S Considerations. Silver has a long history as a safe and effective antimicrobial. Ancient Times Egyptians used in drinking water Roman soldiers used in wound healing Chinese used in eating utensils

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PREVENTION Ag

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  1. PREVENTION Ag Silver Composite Materials: EH & S Considerations

  2. Silver has a long history as a safe and effective antimicrobial • Ancient Times • Egyptians used in drinking water • Roman soldiers used in wound healing • Chinese used in eating utensils • 1880 - Crede's prophylaxis for infant eye drops • 1920's - Over 3 million prescriptions written annually for nanoscale silver-containing (colloidal silver) medications. • 1960's - Silver compounds begin to be used in burn wards • 1980's - Silver ion based additive for plastics become widespread • 1990’s – Silver impregnated medical devices introduced • 2000's – Polymer compatible silver additives developed Aqua-Precision

  3. Encapsulation of silver particles • Prevention Agadditives are delivered as a traditional ready-to-use powder. • As produced, Prevention Ag is a composite powder, ie. particles encapsulated in a micron size polymer stabilizer • Standard PPE (as listed in MSDS) is adequate. micron sized Prevention Ag powders encapsulated Prevention Ag particles Aqua-Precision

  4. Exposure Monitoring • Air Quality Monitoring at The Prevention Ag manufacturing plant(2009, 2010) during manufacture and hopper loading showed silver levels at ~10% of the OSHA Permissible Exposure Limit (PEL) for General Industry (0.01 mg/m3 TWA) and ~1% of the American Conference of Governmental Industrial Hygienists (ACGIH) Threshold Limit Value (TLV) (0.1 mg/m3 TWA) for Silver, Metal. • In vivo studies1 have confirmed that the longstanding 0.1 mg/m3 NOEL for airborne silver compounds is adequate for silver. 1Sung, et al. Subchronic Inhalation Toxicity of Silver and Silver Nanoparticles. TOXICOLOGICAL SCIENCES 108(2), 452–461 (2009). Aqua-Precision

  5. Biocompatibility Testing • Cytotoxicity • Method – MEM Elution ISO 10993 Part 5 1999 ed. • Testing Org – Biochem S.A.S. Predosa, Italy • Test Item – Silver Treated Rayon Absorbent (0.024% Ag/wt) • Conclusions – No Measurable Cytotoxicity Aqua-Precision

  6. Biocompatibility Testing • Sensitization • Method – Test for Irritation and Delayed Type Hypersensitivity ISO 10993 Part 10 1999 ed. • Testing Org – NAMSA, Northwood, OH • Test Item – Polyform AS (50% Ag/wt), Prepared 20%/wt in DMSO • Conclusion – No Significant Proliferation of Lymphocytes * p<0.05 as compared to negative control Aqua-Precision

  7. Biocompatibility Testing • Dermal Toxicity • Method – FHSA Dermal Toxicity Study 7, Day 16 CFR 1500 • Testing Org – NAMSA, Northwood, OH • Test Item – Polyform AS (50% Ag/wt), Administered at 2g/kg • Conclusion - 2g/kg Dose Would not be Considered Toxic ER = Erythema ED = Edema Aqua-Precision

  8. Biocompatibility Testing • Oral Toxicity • Method – FHSA Oral Toxicity Study 7, Day 16 CFR 1500 • Testing Org – NAMSA, Northwood, OH • Test Item – Polyform AS (50% Ag/wt) Dosed at 5g/Kg Body wt • Conclusions – Would not be Considered Toxic at 5g/Kg Dose Aqua-Precision

  9. Biocompatibility Testing • Skin Irritation • Method – FHSA Skin Irritation Study 7, Day 16 CFR 1500 • Testing Org – NAMSA, Northwood, OH • Test Item – Polyform AS (50% Ag/wt), Prepared at 20%/wt in Water * Primary Irritation Index = 1/12 = 0.1 Aqua-Precision

  10. Biocompatibility Testing • Cytotoxicity & Microbial Toxicity • Testing Org – Rice University & University of Duisburg-Essen • Test Item – Silver Salts (Silver Acetate & Silver Nitrate) • – Silver particles (<50 nm diameter) • Conclusion – Biological activity not affected by silver particles • – Antimicrobial properties are directly related to the Ag+ • release (like all other silver-based antimicrobials) • Conc. of Viable Human Cells (relative to control) after exposure to different types of silver. Aqua-Precision

  11. Biocompatibility Testing • Raad, I., et al., Anti-adherence activity and antimicrobial durability of anti-infective-coated catheters against multidrug-resistant bacteria. J. Antimicrob. Chemother., 2008. 62(4): p. 746-750. • Valappil, S.P., J.C. Knowles, and M. Wilson, Effect of silver-doped phosphate-based glasses on bacterial biofilm growth. Applied and Environmental Microbiology, 2008. 74(16): p. 5228-5230. • Kollef, M.H., et al., Silver-Coated Endotracheal Tubes and Incidence of Ventilator-Associated Pneumonia: The NASCENT Randomized Trial. JAMA, 2008. 300(7): p. 805-813. • Weir, E., et al., The use of particles in anti-microbial materials and their characterization. Analyst, 2008. 133(7): p. 835-845. • Roe, D., et al., Antimicrobial surface functionalization of plastic catheters by silver nanoparticles. J. Antimicrob. Chemother., 2008. 61(4): p. 869-876. • Steven L. Percival, P.B.E.J.W., Assessing the effect of an antimicrobial wound dressing on biofilms. Wound Repair and Regeneration, 2008. 16(1): p. 52-57. Aqua-Precision

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