NEW ANTIMICROBIAL PERMANENTLY AND SAFELY PROTECTS MEDICAL DEVICES AND HIGH-CONTACT HEALTHCARE SURFACES

BIOSAFE® Renders Plastics and Textiles Inherently Antimicrobial, Is More Cost-Effective and Faster-Acting than Silver-Based Additives, and Avoids Discoloration

PITTSBURGH, PA, U.S.A., February 4, 2008: An altogether new type of antimicrobial provides permanent protection of medical devices and products for use in clinical settings at much less cost than conventional silver-based additives, while eliminating problems like discoloration, opacity, and concerns about heavy metals, it was announced by BIOSAFE, Inc.

“The enduring effectiveness of our new BIOSAFE® additive, combined with its compelling safety profile, makes this antimicrobial a powerful new tool for reducing the ‘bio-load’ on medical-device and healthcare-environment surfaces,” said Donald J. Wagner II, BIOSAFE vice president for business development.

The BIOSAFE antimicrobial protects plastics and nonwoven fabrics from staining, pitting, deterioration, and odor caused by bacteria, mold, mildew, and fungi; does not compromise end-product safety by migrating out of the plastic or being rubbed off the surface; and does not compromise optical properties when used with high-clarity resins, according to the company.

Applications include catheters, wound dressings, surgical drapes, and many other medical products, as well as human-contact surfaces in healthcare settings, such as doorknobs, drawer handles, light switches, pens, countertops, and keyboards.

The typical loading of BIOSAFE additive required to effectively treat a given quantity of plastic is between 0.2 and 0.5% (the percentage representing antimicrobial alone, not masterbatch). This translates into an additive cost that is at least 33% less than widely used conventional antimicrobials based on silver ion chemistry, which are usually incorporated at 1% levels, according to Donald J. Wagner II, BIOSAFE vice president for business development. “In addition,” Wagner said, “BIOSAFE takes between one and four hours to achieve effective microbial reductions on plastic surfaces—considerably faster than the industry standard of a 24 hour test.”

The basic BIOSAFE product is HM 4100 Antimicrobial, which the company supplies as a solid crystalline powder or in a masterbatch produced for BIOSAFE by RTP Co., Winona, MN.
BIOSAFE products contain no volatile organic compounds, heavy metals, arsenic, or polychlorinated phenols. Toxicity tests have shown them to cause no irritation or sensitization in skin contact. BIOSAFE chemistry is FDA-listed as a modifier to medical devices and has received its EPA label approval.

Antimicrobial Avoids Generating Resistant Strains of Bacteria

The basic component in BIOSAFE products has long been used for protecting textiles from microbial growth but until now has been available only in a liquid solution that had no application in polymer processing. Drawing on organofunctional silane technology, BIOSAFE converted this material to a dry crystalline powder that is thermally stable for use in extrusion and injection molding. When mixed with any common resin and subjected to conventional thermoplastic processing, the BIOSAFE system blends within the base-resin polymer structure, rendering the resulting finished product permanently antimicrobial.

The antimicrobial component of HM 4100 has a structure engineered to puncture and rupture cell walls. By comparison, conventional antimicrobials kill by leaching into the cell, where they are metabolized and interfere with critical life processes. This conventional mode of action has been shown to cause microorganisms to mutate and adapt, becoming resistant to the antimicrobial. BIOSAFE products avoid this problem.

This year BIOSAFE, Inc. will partner with Special Pathogens Lab, a nationally recognized analytical microbiology laboratory, to evaluate the antibacterial properties of computer keyboard covers that have been custom-produced for BIOSAFE and contain its antimicrobial additive. Methicillin-resistant staphylococcus aureus (MRSA) bacteria, now a major source of infection in hospitals and clinics, is transmitted via environmental surfaces such as keyboards, doorknobs, and countertops and contributes to the $11-billion cost of healthcare-acquired infections in the U.S. each year.

Tests comparing the speed and effectiveness of BIOSAFE and conventional silver-zeolite antimicrobials in different resins have had the following results:

● Nylon: Samples containing silver-based antimicrobial showed little more bacterial "kill" after one hour than unmodified control samples, while virtually complete "kills" were exhibited by nylon samples with BIOSAFE®, including one with BIOSAFE added at only one-fourth the level of the silver-based antimicrobial.

● Polyethylene for spun fiber: In tests of BIOSAFE® added at 0.33, 0.50, and 1.00% levels to polyethylene for spun fiber, virtually complete "kills" were exhibited after two hours by the fiber samples with the two highest loadings of BIOSAFE, and even the one with the lowest loading (at 0.33%) showed a substantial "kill" in comparison with control sample.

● Thermoplastic polyurethane (TPU) elastomer: Samples with BIOSAFE® took only four hours to achieve a virtually complete "kill", while samples with silver-based antimicrobial at double the addition level required 24 hours to achieve the same result.

Graphs of these results are available as high-resolution, downloadable jpeg photos at http://picasaweb.google.com/Martinocomms/BIOSAFEAntimicrobial.

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BIOSAFE, INC. supplies antimicrobial products based on two awarded and two pending patents. The company’s core product is BIOSAFE® HM4100 antimicrobial polymer. This is available in the form of a powder for mixing, compounding, and dispersing; can be surface-treated onto pigments and fillers, rendering them antimicrobial; and can be incorporated in water or solvent solutions at various concentrations. The surface-treated fillers can be custom-formulated for a range of technology platforms such as thermoplastic and thermoset resins, water- or solvent-based coatings, adhesives, or caulks. BIOSAFE also supports customers by carrying out antimicrobial testing.

The company is headquartered at 100 Technology Drive, Suite 400, Pittsburgh, PA 15219. Tel: 1-412-770-1302. Email: dwagner@BIOSAFE.com. Visit www.BIOSAFE.com.

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