BIOSAFE^® Organosilane Antimicrobials

BIOSAFE^® is a silicon-based antimicrobial that imparts bacteriostatic, fungistatic, and algistatic properties to coatings and resins for manufactured goods. It is available as a powder, solvent or aqueous solutions. With proper integration, BIOSAFE® products have high antimicrobial performance in ISO and ASTM testing. The active ingredient in the BIOSAFE^® Antimicrobial was developed and registered with the EPA in the mid 1970s, and has since been widely utilized in numerous applications for over 35 years. BIOSAFE^® has expanded the breadth of applications and manufacturing processes by removing the VOCs and making it available in a new polymeric powder. This powder, similar to its solvent-based predecessors, can be formulated into coatings, but unlike its predecessors, the powder can be compounded with polymer resins.

The antimicrobial, when properly incorporated in accordance with the instructions and specifications 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.

The active ingredient in BIOSAFE^® forms a colorless, odorless, positively charged polymer that molecularly bonds to your product’s surface. 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. Because of this physical kill mechanism, BIOSAFE^® does not promote the development of drug resistant superbugs.

The demand for antimicrobial agents is on a steady rise and will continue to grow in the coming years. The conventional antimicrobial agents are silver based or triclosan based, each of which have their own disadvantages either in terms of cost or leaching from the treated surfaces and ending up in the water stream.

BIOSAFE^® is a new class of anti-microbial which is derived from organo- functional silanes. Not only does BIOSAFE^® have the anti-microbial properties, but it also has the unique properties of a silane to be able to covalently bond to a substrate.

BIOSAFE^® in its powder form can also be used as an additive in coating formulations or compounded with plastics to create materials that are inherently anti-microbial. The ability to covalently bond to a substrate prevents Biosafe® from leaching.

BIOSAFE^® does not display any color change which is a common problem with the silver based antimicrobial agents. Details on the wide range efficacy of action for BIOSAFE^® will be presented along with its comparison to the most commonly used antimicrobial agents.

A microbe’s only protection from the outside world, the cell wall, is about 20 nanometers thick. 1/1000th the thickness of a plastic grocery bag, thin and vulnerable.

Yet most antimicrobial technologies are designed to pass right through the cell wall and attempt to poison the microbe from the inside, interfering with its metabolism and altering its DNA. This leads to mutations and resistant-adaptive superbugs! What a bad idea! Silver and triclosan, both chemicals that operate in this manner, are technologies that have increasing health and safety concerns globally, both for toxicity and mutation and adaptation of super-bugs.

BIOSAFE^® is not metabolized by cells, it creates a network of charged particles that pop cells like a balloon, on contact. The technology takes advantage of the weakness of the cell wall and ruptures it with this physical/electrical force. BIOSAFE^®’s invisible coating adheres to hard surfaces and fabrics, and is ready to destroy any microbes that come in contact with it. What’s more, it provides durable, long lasting protection for 30 days. This physical rupturing of the cell wall is the best way to kill a microbe. It does not lead to resistant superbugs, and the active is not leached into the environment or person, as occurs with silver and triclosan technologies. Antimicrobials are not all created equal. BIOSAFE^® is the only antimicrobial polymer in its class that provides unmatched safety and performance.

BIOSAFE^®’s powder and water based solutions are registered with EPA’s Antimicrobials division as EPA Reg. No. 83019-1,2,3

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, not people, per EPA regulations. The key distinction is that these are non-health claims. 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.

When deciding to use an antimicrobial additive, the first thing to consider is the required product performance and how marketing claims will communicate that performance. is is the common starting point for all antimicrobial products. The formula used for a product controlling algae in water lines will differ from the formula controlling either odor-causing bacteria in a refrigerator gasket or damaging mold and mildew in building materials. The activity of a microbiostatic treatment on a bulk surface or textile, such as BIOSAFE^®, are verified by standardized industry methods.

Test methods commonly used to determine the antimicrobial activity of solid treated articles are:

• JIS Z 2801 – a method where microbes are inoculated onto an antimicrobial surface and covered for 24hrs, and survivors are counted.
• ASTM E2149 – a method where the material is immersed and shaken in a microbial solution for 1hr, then removed, and surviving organisms are counted.

Third party verification is available from labs that perform this type of “treated article” testing. Please contact us for recommendations of independent third party labs that are EPA and FDA compliant.

When reviewing results from microbiological studies it is important to understand the definitions of the terms and scope of the numbers. Results are reported in either percent reduction or scientific notation.

• 1 log reduction = 90% reduction
• 2 log reduction = 99% reduction
• 3 log reduction = 99.9% reduction
• 4 log reduction = 99.99% reduction
• 5 log reduction = 99.999% reduction
• 6 log reduction = 99.9999% reduction

So, if reviewing a study report from a lab indicating a 3.5 log reduction, then you know it corresponds to a percent reduction somewhere between 99.9% and 99.99% but a 2.5 log reduction does not equal a 99.5% reduction.

These tests were conducted under GLP protocol

• Cytotoxicity: Agar Diffusion Assay ISO 10993-5
• Acute Dermal Toxicity OPPTS No. 870.1200
• Acute Dermal Irritation OPPTS No. 870.2500
• Acute Eye Irritation OPPTS 870.240
• Acute Oral Toxicity Study (USP) OPPTS 870.1100
• Acute Inhalation Toxicity Study OPPTS 870.130
• Skin Sensitization: OPPTS 870.2600
• HRIPT- Human Repeat Insult Patch Test: 48 day
• AMES- Mutagenicity Study

*all studies are available for review upon request

Does this product have EPA registration?

Yes, the active ingredient in BIOSAFE^® is a patented and EPA registered siloxane polymer EPA Reg. No. 83019-1-4. Coating and treated articles themselves are exempt from registration under 40 CFR 152.25(a).

How has the BIOSAFE^® been tested?

The antimicrobial effectiveness and safety has been verified by independent GLP/EPA registered labs:

• Antimicrobial Effectiveness
  ISO 22196:2007
  ASTM E-2149-10
• Safety Studies
  USP Class VI
  ISO 10993-1
  EPA Acute Toxicity Package

BIOSAFE’s antimicrobial effectiveness is verified by ISO and ASTM standards as related to the product and its use.

What can I apply BIOSAFE^® into/onto?

BIOSAFE^® can be incorporated into or applied on to any hard, non-porous surface, any textile, upholstery, or soft porous good. It’s ideal for bulk surfaces and for fabrics that are susceptible to microbial contamination.

How does the BIOSAFE^® technology work?

The active ingredient in BIOSAFE^® forms a colorless, odorless, positively charged polymer that molecularly bonds to your product’s surface. 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. Because of this physical kill mechanism, BIOSAFE does not promote the development of drug resistant superbugs.

The polymeric antimicrobial powder HM4100 can be dry blended into the bulk resin by any variety of standard mixing operations. The powder will adhere to the surface of the bulk resin particles and become homogeneously mixed. Following mixing the HM4100 into the host resin, it is ready for molding, extrusion, or other thermoplastic processes to make the finished good. Care should be taken to keep this mixture in a dry environment. In certain resins it is recommended that the mixture be dried before it is used. HM4100 is hygroscopic and can hold 5% moisture.

Applying BIOSAFE^® to surfaces can be accomplished by the following sequence: Typical substrate candidates include carpet, apparel, non-wovens, roll goods, building materials, shoes, and indoor environment surfaces.