BioLabME Organic Sanitizer underwent a SARS-CoV-2 (COVID-19) Virucidal test by Suspension method EN 14476 on 25-Jan-2021

CONCLUSIONS:  1  Minute exposure period
Considering the cytotoxicity and neutralisation test results, the sample has shown virucidal efficacy against MHV1 by achieving 5.81 log reduction in virus concentration after 1 minute exposure period at room temperature.

CONCLUSIONS:  5  Minutes exposure period
Considering the cytotoxicity and neutralisation test results, the sample has shown virucidal efficacy against MHV1 by achieving more than 6.50 log reduction in virus concentration after 5 minutes exposure period at room temperature.

This means that SARS-CoV-2 (COVID-19) is eliminated 99.9999% by our product.

Any virus needs a host to be able to grow and replicate itself. This host is normally another cellular organism like a plant or animal or human cell, or bacterial cell which contains an RNA or DNA configuration. The virus needs to attach itself to this host organism in order to be able to replicate. This attachment is very specific depending on the type of virus. Every virus is surrounded by a protective protein-like structure that also acts as food source before it attaches to a host.

This food source has a limited lifespan therefore viruses cannot float ad infinitum without attaching to a host. Flavonoids have been studied against a wide range of DNA and RNA viruses. In general, flavonoids work by several mechanisms in “fighting” viruses. They can block attachment and entry of viruses into cells, interfere with or disturb various stages of viral replication processes or translation and polyprotein processing to prevent the release of the viruses to infect other cells. This is known as “virus isolation” or “failure to attach”.

The virus does not find a source for replication and becomes isolated – leading to the demise of the virus. We have sufficient scientific peer reviewed material confirming that at least one of the complex of flavonoids contained in BioLabME Organic Sanitizer actively destroys parts of the attachment mechanism or critical components of the protein layer around the virus, causing it to NOT be able to attach and replicate adequately – leading to its demise and destruction. Our organic sanitizer does not kill – the virus is destroyed because its life support systems are destroyed by BioLabME Organic Sanitizer.

We have all the right supportive published scientific reporting that the mechanisms of action of the flavonoids included in our organic sanitizer significantly inhibits the ability of corona-type viruses to effectively attach to a host and replicate.

En 14476 is an antiviral textile test that performs the measurement of viral antimicrobial activity for sanitizers and disinfectants.

The EN 14476 test method provides a test method for the quantitative evaluation of the virucidal activity. Products intended for assessment by the test method are considered to be disinfectant and antiseptic products that are homogenous and stable, and may or may not be diluted before use (known as ready to use RTU, or as concentrates).
As part of determining the appropriate scope for antiviral testing of a product, the intended category for the product application is used to define the exposure time and test conditions for determining the antiviral performance of the product. The four product application categories are; Hygienic Hand Cleaners; Instrument Disinfection, Surface Disinfection, and Textile Disinfection. For the different product categories, the exposure times range from 30 seconds to 60 minutes. In addition to the exposure time, testing can incorporate hard water dilutions, soiling, and a range to different virus types.
Many virus types can be tested, common types include influenza and coronavirus strains. The actual performance of the treated textile is determined by viral titer measurements using a plaque assay or TCID50 method (Median Tissue Culture Infectious Dose) similar to a most probable number serial dilution measurement.

The EN 14476

Common Antimicrobial Additives

Standard mechanisms for antiviral solution testing require additives that can chemically or dynamically modify some aspects of the virus. Drug strategies rely on highly specific binding to the virus (known as receptor-ligand binding) where the receptor is on the virus and the ligand is the drug used to bind to the receptor blocking its mode of action.

For treated products, a more common approach is to chemically attack a more general aspect of the virus. For coronavirus, which has a fatty (lipid) envelope, antiviral products will adhere to the membrane and disrupt it by causing it to lose its characteristic shape and therefore its ability to infect. Common classes of antimicrobials for that activity used are reactive aldehydes, oxides (hydrogen peroxide or peroxyacetic acid), quaternary ammonium compounds, essential oils, and quaternary-silane molecules (quat-silane).

For liquid disinfectant applications, the priority tends for a fast rate of action, so the favored compounds commonly use are aldehyde chemistries (formaldehyde, and glutaraldehyde), hypochlorite, peroxides and to some degree quaternary ammonium compounds. More commonly are combinations of compounds such as peroxides and quaternary ammonium compounds that can perform antiviral actions in a so-called ‘synergistic’ way, provide very fast action with a high-level of antiviral efficacy, at lower antimicrobial additive concentrations.

Many customers will request durability testing in companion with EN 14476 testing to determine the antimicrobial performance against viruses when exposed to environmental conditions. The most commonly used forms for durability include soiling (or dirty) conditions, known as interfering substance. Commonly serum, blood, or hard water are used.

Utilizing both Durability and Antimicrobial testing through Situ Biosciences’ product test laboratory can support product development and performance testing while reducing the time and costs associated with developing and distributing quality products on the market. One caution is that durability assessments need to be well controlled for the effects of residual cleaning products and therefore must be well designed for the intended purpose of the treated product.

What is Log Reduction and % reduction?

1:  During product efficacy testing, the Microbiology Laboratory count the number of colony forming units (CFU’s) of the given pathogen present at the start of the test.

2:  They then apply the product being tested, alongside a control product and wait the required test time before recounting the number of CFU’s present.

3:  The efficacy of a product at reducing pathogens is a result of the difference between the control and the test product, expressed as a Log reduction.

4:  The greater the log reduction the more effective the product is at killing germs and other pathogens that can cause infections.

‘Log’ is short for logarithm, a mathematical term for a power to which a number can be raised.

E.g.: using 10 as a given number, a Log 4 increase can be shown as 10⁴ or 10 x 10 x 10 x10 = 10,000.

A log reduction takes the power in the opposite direction. E.g.: Log reduction of 1 is equivalent to a 10-fold reduction (moving down one decimal place or a 90% reduction)

If the number of CFU’s in the control was found to be 1,000,000 (or 10⁶) and the end result using the product was only 1,000 (10³), that would be a Log reduction of 3 or a reduction of 99.9%.

For every additional Log reduction number, add a 9 to the % reduction: a log reduction of 3, as illustrated above, is a 99.9% reduction compared with a log reduction of 6 which is equivalent to a 99.9999% reduction.

A summary of log reduction values using a starting point of 1,000,000 CFU’s is outlined below:

Our test results as a working example:

Tested according to EN 14476 against MHV1 using a contact test time of:

1 Minute: Log 5.81 / >99.999 % reduction

5 Minutes: Log 6.50 / >99.9999 % reduction

Conclusion:

Longer exposure time results in a higher efficacy in eliminating Covid-19

The product is currently used in different applications in the cosmetic industry, the food preservation industry and other small businesses where sanitation is important. There are also applications currently installed in walkways of buildings where application is done through larger mist sprays.

The product has been available in different formulations since 2008.

The production has started in South Africa, while new production facilities are currently under development in the United States and Europe.

BioLabME Organic Sanitizer acts through a process of cell wall intrusion, complexation of key cations and disruption of protein functioning. Through these mechanisms our Organic Sanitizer effectively and efficiently suppresses various pathogenic cellular organisms such as bacteria, fungi and molds, and non-cellular organisms such as viruses on all surface areas.

Yes, it has been approved and certified by all the below institutions:

• Ceres organic approval
• Ceres confirmation of non-chemical content by Eurofins (Germany)
  Confirmation of food safety from SA Dept of Health
• SANAS accredited
• ILAC MRA LD50 Acute Oral Toxicity Tested
• ILAC MRA Repeated Skin Toxicity Tested
• ILAC MRA Acute Eye Irritation Tested
• ILAC MRA Acute Inhalation Toxicity Tested

The Flavonoid range of products are well known for more than 14 years in the agriculture industry, focus in on the health of all crops. Focus has been put on the microbiome of all living creatures – from plants and animals to humans. The CERES certification in particular explicitly states that the product is safe for use in an environment where humans and animals interact freely – like in an agricultural environment.

No, health benefits to exposed individuals whilst promoting a protective and restorative respiratory experience to the individual. The formulations can be absorbed through the skin and the mucus membranes of the body, nose, mouth and lungs, making it a very suitable carrier for the flavonoids to be absorbed in the bloodstream and as such reach the important infected areas in the respiratory channel which is directly affected by Covid-19.

The positive effect of flavonoids on the different aspects of human health have been extensively researched over an exceptionally long period. This means that, even if there is no direct risk of infection the product still has distinct hygiene benefits for the individual when inhaling it. This is directly due to the strong beneficial impact of the active flavonoids in the product on the strengthening and improving of the health of the human cells they interact with.

Our product is non-alcohol based because alcohol has distinct disadvantages in terms of its acceptability in sanitizing as we formulated it. It is harmful to the skin and has specific disadvantages as solvent for use in mist sprays. Over and above the fact that it damages the skin, the inhalation of alcohol has distinct disadvantages to human health.

This has been extensively documented in the literature. The dangers of using alcohol in a mist spray are well known. The viscosity of alcohol is also not very conducive for use in mist sprays. People who inhale alcohol vapors could become intoxicated quickly, because alcohol can quickly pass through the blood-brain barrier, reaching neurons directly. Alcohol is highly flammable. BioLabME Organic Sanitizer is a water-based solution with absolutely no flashpoint.

With specific reference to underground mining, our product has NO flashpoint, is NOT flammable and thus is the perfect solution for underground mining environment and is effective above ground too. This is because it is non-alcohol based and non-chemical containing – substances that may cause flammability.

The use of chlorine to spray in confined areas is also life threatening if not extremely well controlled at VERY LOW concentrations not exceeding 0.1 – 0.3 ppm. Dosages of 50 ppm as mentioned are deadly and can cause SEVERE human health issues, like pneumatic oedema and other profoundly serious lung diseases.

These will then severely compromise the immunity of the individual and significantly increase the susceptibility to viral and other pathological infections. Both chlorine and alcohol are implicated as being dangerous substances in the Health and Safety Regulations for Mines.

To start off with – there is a particularly important and distinct difference between sanitizers and disinfectants.

Disinfectants are formulated and produced to sterilize the areas where they are applied. That means they kill ALL organisms prevalent in the areas where applied. Sanitizers are formulated and developed to mostly sanitize the environment and surfaces where it is used in from harmful organisms, leaving beneficial organisms to flourish.

In BioLabME Organic Sanitizer the combination of selected flavonoid and plant-based extracts in the formulation contain the active flavonoids that effectively kills harmful organisms. This fungicidal and bactericidal properties in OrganicFresh Sanitizer are duly certified by leading international laboratories.

Earlier in this document we described that our product is non-alcohol based since we use 100% non-alcohol and non-chemical ingredients and production processes that have been certified by leading international laboratories. Our organic sanitizer is not based on a strange theory – it is based on mainstream international research that has been conducted the past 80 years but has been largely ignored. There is currently ongoing research in leading global institutions on specific aspects and mechanisms of action entrenched and included in our organic sanitizer. It has a well-developed and credible scientific base from where it is developed.

Can we get documentation or an official letter stipulating that this product is effective in disinfecting/sanitizing against the covid-19 virus especially to our employees and facilities?
This is not possible due to our certifications and the fact that there are no medical tests to support such claims.

Infection mostly takes place via the mucus membranes in the eyes, mouth, nose and throat – after the virus has been introduced through some transfer activity, like the hands or mucus drops in the air due to sneezing or coughing of carrier individuals. From there the drive to wash hands. None of the alcohol-based products can be applied anywhere other than the hands. They are mostly harmful to humans when ingested.

BioLabME Organic Sanitizer radically and distinctly differs from this in that it has been CERTIFIED to perform its sanitizing function ANYWHERE it meets harmful organisms. This INCLUDES the mouth and the nose and the airways to the lungs. Its natural beneficial action on human cells means that, even in the event of no infection it still has a POSITIVE EFFECT on the human cells it encounters. With or without infection it meets the criteria for beneficial mechanisms of action to benefit human hygiene.

OrganicFresh Sanitizer is a natural substance consisting of natural combinations of flavonoids and plant extracts. None of it’s components have shown to cause harmful effects with regular use since they occur in many different parts of everyday life from food to human hygiene applications.

During normal use it is safe for indoor and outdoor as well as underground. It is, however, crucial to make sure you are well acquainted with the Safety Data Sheet and follow the requirements and instructions.

BioLabME Organic Santizer is NOT a biocide since it does not meet the definitive description of what a biocide is. It is a sophisticated complex of flavonoids and other botanical extracts focusing on the sanitation of contaminated environments. Although it destroys potentially pathogenic organisms, it is also professionally researched and hailed as being immensely powerful in its composition favouring the improvement and sustenance of the general health of the host cells where it makes contact.

Where biocidal active substances are mostly chemical compounds, sometimes containing microorganisms (e.g. bacteria), BioLabME Organic Sanitizer contains NO micro-organisms or chemicals, and its ingredients and manufacturing processes have been CERES certified to meet the criteria set for human food safety. It does also NOT contain any biocidal active substances or any other non-active co-formulants that ensure the effectiveness as well as the desired pH, viscosity, colour, odour, etc. of the final product.

BioLabME Organic Sanitizer is a carefully and professionally formulated sanitizing agent that is focusing on skilfully employing the anti-bacterial, anti-fungal and anti-viral properties of a bouquet of plant based flavonoids and other botanical extracts in promoting a sanitized living environment whilst actively enhancing the general health of the individual exposed to its sanitizing action. This is a unique mechanism of action clearly separating it from biocidal activity.