BIOSAFE - Organosilane Antimicrobials
About Antimicrobial Surfaces
Antimicrobial additives for surfaces and textiles perform differently and are regulated differently than sanitizers or
disinfectants. Antimicrobial “additives” are considered to be microbiostatic agents that protect products as  BIOSAFE is used to protect any material or textile, under its approved uses, to mitigate or stop the growth of product damaging microbes. Key considerations regarding the end-product’s performance include its environment, the wearability of the surface, and the degree of microbial control needed to achieve the product’s purpose.

What does BIOSAFE do?the antimicrobial, when properly incorporated in accordance with the instructions and speci!cations provided, imparts a protective bacteriostatic, fungistatic and algistatic surface on substrates to prevent deterioration and discoloration caused by fungi, prevent algae growth and inhibits the growth of odor-causing bacteria. It is durable, leach resistant, and non-migrating. It does not create the conditions that promotes the development of resistant microorganism.

Comfort52 applications: The active ingredient formed in a colorless, light odor, positively charged polymer that via jet-fog process, molecularly bonds to the treated area`s interior surfaces. The strong positive charge disrupts the cell membrane of all microorganisms that come in contact with the active surface, thereby causing their cytoplasm and organelles to leak out. It resembles popping a water balloon. The BIOSAFE-Mobgraz/2 does not promote the development of drug resistant superbugs.

BIOSAFE ASTM 2140-01 Laboratory Test**


             

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An Evaluation of Safety and Efficacy of the Crosstex® Face Mask treated with BIOSAFE®Antimicrobial Agent. **

INTRODUCTION

Crosstex surgical masks are designed to reduce infection in a wide variety of clinical and other settings. They provide a defensive barrier against pathogenic microorganisms. Masks are designed to filter varying sizes of organisms, thereby trapping them and not allowing them to pass through the mask.3 Once captured, pathogenic microorganisms can continue to live within the fibers of the mask for days.2 This technical paper discusses the effect of a new antimicrobial technology upon pathogenic microorganisms trapped on the filter media of a Crosstex mask.

Test methods are described as follows: Safety Testing of BIOSAFE Treated Masks

The following tests have been performed by highly accredited independent laboratories to demonstrate that the safety of the BIOSAFE treated masks meets the standards of the International Organization for Standardization  (ISO):

The efficacy of BIOSAFE treated face masks has been tested following the ASTM method for determining the antimicrobial activity of immobilized antimicrobial agents  under dynamic contact  conditions {ASTM E 2149- 01). The test organisms were Staphylococcus aureus, Pseudomonas aeruginosa, Enterococcus faecalis, Salmonella enterica, Methicillin Resistant Staphylococcus aureus (MRSA),and Vancomycin-Resi stant Enterococcus  (VRE).

As described within this document the masks are shown to be safe and, in lab testing, BIOSAFE treated Crosstex masks have proven effective against:

• Staphylococcus aureus (Staph)

•  Methicillin Resistant Staphylococcus aureus (MRSA)

• Vancomyci n-Resistant Enterococcus (VRE)

RESULTS

The BIOSAFE masks passed all of the safety tests. Antibacterial Efficacy:

Table 1shows the percent reductions of Staphylococcus aureus, Methicillin Resistant Staphylococcus aureus, and Vancomyci n-Resistant Enterococcus on BIOSAFE treated masks at 5 and 10 minute inoculations (kill times). Influenza A is also shown in this table.

Table 1:Percent Reductions of Microorganisms on BIOSAFE Treated Masks

Kill Time

5 minutes

10 minutes

30 minutes

Staphylococcus aureus

> 99.999%

> 99.999%

NA

MRSA  (Methicillin-resistant

Staphylococcus aureus )

--

> 99.8%

--

VRE (Vancomycin-resistant

Enterococci )

--

99.4%

--

Enterococcus faecalis

> 99.999%

> 99.999%

NA

Salmonella enterica

> 99.99%

> 99.999%

--

Pseudomonas aeruginosa

> 99.999%

> 99.999%

NA

Influenza A

98.5%

--

99.3%

•  H3N2 used as a surrogate for all Influenza A viruses including H5N1 (avian or bird flu), navel H1N1 (swineflu), and other strains

•    Worn by healthcare providers to prevent accidental contamination of patients' wounds by the organisms normally present in mucus and saliva.

•    Worn by employees to protect themselves from splashes or sprays of blood or body fluids; they may also have the effect of keeping contaminated fingers/hands away from

the mouth and nose.

CONCLUSIONS

1. The results of biocompatibility and cytotoxicity studies at highly accredited independent laboratories utilizing ISO Standards indicated that BIOSAFE treated Crosstex masks are safe to use.

2. The results of the microbiology testing indicate that BIOSAFE treated Crosstex masks kill or inactivate at least 99% of the harmful bacteria and viruses tested within 10 minutes of contact with the mask.

1 REUSABILITY OF FACEMASKS DURING AN INFLUENZA PANDEMIC FACING THE FLU Committee on the Development of

Reusable Facemasks for Use During an Influenza Pandemic Board on Health Sciences Policy INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES THE NATIONAL ACADEMIES PRESS Washington, D.C. www .nap.edu 2 Journal of Clinical Microbiology. 2000 February; 38(2): 724--726 .3 Guidance on Preparing Workplaces for an Influenza Pandemic OSHA 3327-02N 2007 4 AORN 2005 5 Interim Guidance on Planning for the Use of Surgical Masks and Respirators in Health Care Settings during an Influenza Pandemic

October 2009

** This is an excerpt of the full efficacy test. Should you require to have the full version, please request it by email.



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Corporate Headquarters: Hauppauge, NY 11788-4209 USA • Tel: 631-582-6777 • 888-CROSSTEX • Fax: 631-582-1726 Website: www.crosstex .com • E-mail: crosstex @crosstex.com


         



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