PRODUCTS

WELCOME TO THE WORLD OF COLD CHEMICAL STERILIZATION

EFFECTIVE, SAFE AND EASY TO USE

WHAT IS K-LLER^®?

K-LLER^® is a 6th generation polymeric allogenated compound with characteristics of the ideal disinfectant described by APIC1, being in turn a biodegradable cold chemical sterilizer.

Lauryl Dimethyl Benzyl Ammonium Bromide 0.16%

One of a kind polymer

PRODUCT COMPOSITION

Complete formulation in the chain:

0.16% Benzalkonium Bromide Polymer

Inert Ingredients C.S.P. 100%

A polymeric compound is a more complex and well differentiated substance from the simple chemical substances known up to now. Macromolecule made up of the repetition of several chemical units, called “monomers”.

For reasons of structure, shape, size, surfactant capacity, toxicity and disinfectant / sterilizing action, polymeric quaternary compounds must be considered very different from quaternary ammoniums known and used hitherto.

Each polymer is unique, just a small change in its synthesis or structure, gives rise to a different polymer.

That is why K-LLER® is unique and very different from the sterilants and disinfectants known to date.

PHYSICOCHEMICAL CHARACTERISTICS

Aqueous Solution Appearance Liquid1
Odor: Odorless
Color: Colorless2 pH: 7 ± 1.
Soluble in polar compounds, insoluble in non-polar compounds
Cationic surfactant
Not volatile
Action Stability: -5º C to 130º C
Specific Weight: (H2O = 1) 1.008 @ 20º / 20º

REACTIVITY DATA

Stability: Stable under normal handling conditions
Spontaneous polymerization: Not Determined.
Dangerous derivatives of its decomposition: None. The product does not decompose spontaneously.

INCOMPATIBILITY

Anionic agents can neutralize the active ingredient. Follow the table with the main products, and their derivatives, that inactivate K-LLER®. All halogenated compounds inactivate it. In contact with them, nonpolar and useless molecules like this one are formed.

Incompatibility data:

BORIC ACID
DETERGENTS
SULPHATED
SODIUM CITRATE
HYDROGEN PEROXIDE
SODIUM SULFATE
ZINC IODOPHOSORES PEROXIDE

SILICATES
SOLUBLE
ZINC SULPHATE
CALCIUM OR DERIVATIVES
CHLOROPHYLL SODIUM HYPOCHLORITE
SILVER NITRATE

PERMANGANATE
TANNIN
ACID PHENOLS
NITRIC
GLUTARALDEHYDES FORMALDEHYDES
BIGUANIDAS

QUICK ACTION

SPREAD SPECTRUM

K-LLER® is a unique product, capable of lysing microbial loads by contact and in the case of sporulated and mycobacterial forms in a time of 22 minutes, without risk of toxicity for living beings.

K-LLER® Mechanism of Action

K-LLER® is a cationic surfactant that functions as a cell membrane disturbing substance, an activity that leads to the lysis of microbial coatings and therefore cell death.

Bactericidal Activity

Bactericide, for the microorganisms in the indicated table, undiluted, after 5-10 minutes^4,5.

Fungicidal Activity

Fungicide, for the microorganisms in the indicated table, undiluted, after 5-30 minutes of exposure^6,7.

Sporicidal Activity

Sporicide, for some microorganisms in the table below, undiluted, after 22-30 minutes of exposure^8,9.

Mechanism of action of K-LLER® in viruses

K-LLER® is a cationic surfactant that functions as a cell membrane disturbing substance, an activity that leads to the lysis of microbial coatings. K-LLER® has been shown to accelerate the dissolution rate of cholesterol in digestive micelles, an effect that it exerts through the reduction of the interfacial barrier between bile salts and cholesterol.

In concentrations lower than that found in the product, the active component of K-LLER® is also an activator of regulatory heterotrimeric proteins that interact with the guanine nucleotide (G proteins). Therefore, and as has been demonstrated with HIV, the K-LLER® product has several properties that explain its retroviricidal action, including: (1) lysis of the viral coat; (2) inhibition of reverse transcriptase activity; (3) inhibition of T cell proliferation, which is required for the replication of the HIV virus in said cells; (4) inhibition of G proteins, some of which are coupled to receptors used by the HIV virus to enter cells; and (5) inhibition of the production of tumor necrosis factor alpha, a cytokine that stimulates the lymphoproliferative activity of T cells and the replication of the HIV virus.

Viricidal Activity

IN VITRO tests demonstrated its Viricidal action, by contact, for Human Immunodeficiency Syndrome Viruses (V.I.H). Herpes Virus and Human Papilloma Virus (V.P.H)10.

Viricidal, undiluted, on Herpes Simplex Viruses Type 2, Adenovirus Type 3 and Viruses HPV 6, at 15 minutes of exposure11. Similarly, viricidal activity of K-LLER® was demonstrated for enveloped viruses (eg: Influenza Virus, Respiratory Syncytial Virus, HCV, etc.) and non-enveloped viruses: Enterovirus (Hepatitis A and Rhinovirus), Parvovirus, Rotavirus, etc., after 30 minutes of contact.

Mechanism of action of K-LLER® in Mycobacterium tuberculosis

The cell wall of M. tuberculosis is made up of a rigid membrane, divided into 4 layers. The innermost, together with the cytoskeleton, composed of peptidoglycan consists of an arrangement of parallel chains of N-acetylglycosamine and units of muramic acid. Through a covalent bond of the phosphated disaccharide region, the peptidoglycan is bound to the arabinogalactan-mycolate structure, thus forming the backbone of the cell wall.

Finally, the outer layer is composed of: lipids, glycolipids and proteins, varying considerably between the Mycobacterium species. Between the glycolipids associated with the wall and acting as a plasma, a layer of lipoarabinomannose (LAM) is anchored. It seems to perform relevant biological activities in the etiopathogenesis of tuberculosis, and among which are included: inhibition of T cell activation; inhibition of macrophage activation by interferon; and inhibition of protein kinase C activity and macrophage induction in the production of various cytokines, including TNF.

K-LLER® can act on the skeleton of the Mycobacterium tuberculosis cell wall, more precisely on the phosphate covalent bonds of the mycolato-arabinigalactan-peptidoglycan structure, interfering in its architecture, promoting a protein denaturation action, together with the litter of peptidoglycan. The LAM can then be released, weakening the entire structure and providing the initiation of an ionic imbalance and consequent cell death.14.

Tuberculicidal Activity

IN VITRO tests demonstrated its tuberculocidal action, for Mycobacterium tuberculosis, in a contact time of 10 minutes. Likewise, the mycobactericidal activity of K-LLER® was demonstrated against Mycobacterium smegmatis and Mycobacterium bovis in a contact time of 30 minutes.13.

K-LLER®, was awarded the order “Dr. JOSE SILVEIRA ”as a product of technological advance in the eradication of contamination from Fixed Surfaces and medical equipment and Tuberculosis in Brazil.

K-LLER®

PROVIDES SECURITY

K-LLER^® is a product that offers security to its users:

Personal médico, profesional de enfermería, limpieza/mantenimiento, pacientes y al medio ambiente.

It is not corrosive
It is not toxic. Lethal Dose (LD50):> 12,000mg / kg weight^15,16
It is not volatile. Harmful effects are not anticipated by eventual aspiration by nebulization or "spray".¹⁸ Al contacto con los Ojos o la Piel: No es toxico ocular ni irritante^15,16
It is not absorbed through the skin
In case of ingestion its Lethal dose (LD50):> 6,000mg / Kg weight¹⁷
It is not flammable
Does not generate Hazardous Gases
In case of spillage, it can be left to dry spontaneously
It is Biodegradable
K-LLER® waste can be disposed of in the trash can system

K-LLER® IT IS THE IDEAL DISINFECTANT

Broad Spectrum | Fast action
It is not affected by environmental factors
Non Toxic | Without smell
No toxic residues on surfaces
Soluble in water | Not Corrosive

References:

(1) Determined by the chemistry section of "LABORATORIES OF QUALITY CONTROL, COSMETICS, FOOD AND DRUGS C.A.M.", within the framework of the conditions of the standards established in the test method "USP 23, PAG. 1721; TITULACION EPTON ”AWARD No D971103.003

(2) Determined by the chemistry section of "LABORATORIES OF QUALITY CONTROL, COSMETICS, FOOD AND DRUGS C.A.M.", within the framework of the conditions of the standards established in the test method "USP 23, PAG. 1721; TITULACION EPTON ”AWARD No D971103.003

(3) Determined by the chemistry section of "QUALITY CONTROL, COSMETICS, FOOD AND DRUG LABORATORIES C.A.M.", within the framework of the conditions of the standards established in the test method "USP 23, PAG. 1721; TITULACION EPTON ”AWARD No H971103.003

(4) Carried out by "Instituto Venezolano de Investigaciones Científicas (I.V.I.C.)", within the framework of the conditions of the standards established in "The Association of Analytical Chemists - AOANC"; "The Association of Official Agricultural Chemists - AOAC"; "The Food and Drug Administration- FDA" Bactericide, for some microorganisms in the table below, undiluted, after 5 minutes of exposure, carried out by several institutions through their own methodologies.

(5) Enhanced by the Microbiology section of "LABORATORIES OF QUALITY CONTROL, COSMETICS, FOOD AND DRUGS C.A.M." Bactericide, for some of the microorganisms in the table below, undiluted, after 10 minutes of exposure, carried out by BIOAGRI Laboratorios Ltda. - Award N ° RF-AA02.94 / 00, in accordance with the standards established in the " National Institute for Quality Control in Health (INCQS) ”.

(6) Carried out by, “Venezuelan Institute of Scientific Research (I.V.I.C.)”, within the framework of the conditions of the norms established in “The Association of Analytical Chemists - AOANC”; "The Association of Official Agricultural Chemists - AOAC"; "The Food and Drug Administration - FDA".

(7) Carried out by the Microbiology section of "LABORATORIES OF QUALITY CONTROL, COSMETICS, FOOD AND MEDICINES C.A.M.", within the framework of the conditions of the standards established in the test method "USP 23, PAG. 1721; EPSON TITULATION ”AWARD No A97103003 and made by“ BIOAGRI Laboratorios Ltda. ”, AWARD N ° AA-95/00.

(8) Carried out by the "Venezuelan Institute of Scientific Research (I.V.I.C.)", within the framework of the conditions of the standards established in the test method "The Association of Analytical Chemists - AOANC"; "The Association of Official Agricultural Chemists - AOAC"; "The Food and Drug Administration - FDA"

(9) Made by "Mycobacteria Laboratory - Institute of Biomedical Sciences University of Sao Paulo, in Brazil, within the framework of the conditions of the standards of" Fundação Oswaldo Cruz - National Institute of Control of Qualidade em Saúde "- Manual da Qualidade - Method for avaliação da atividade sporocida, number 53.3204.005.

(10) Carried out by the “Departments of Medicine, Microbiology and Immunology; University of Miami School of Medicine, E. M. Papper Laboratory of Clinical Immunology, U.S.A. by Dr. Mary Ann Fletcher and Dr. Roberto Patarca "

(11) Demonstrated by the "Institute of Biomedical Sciences - Department of Microbiology - University of Sao Paulo" in Brazil.

(12) Demonstrated by the "Institute of Biomedical Sciences - Department of Microbiology of the University of Sao Paulo" in Brazil.

(13) Carried out by the "University of São Paulo, Institute of Biomedical Sciences, Department of Microbiology, Mycobacteria Laboratory"

(14) Mycobacterium tuberculosis; Molecular action of Lauryl Dimethyl Benzyl Ammonium Bromide. Based on the model of the biochemical structure of the cell wall of Mycobacterium tuberculosis (Brennam & Draper; 1994), it is possible to estimate the bactericidal action of 0.16% lauryl dimethyl benzyl ammonium bromide demonstrated in vitro (Santos 1998).

(15) TecPar - Award N ° 26.08.96 and N ° 52260-00014869; BIOAGRI Laboratorios - Award No. RF- F4.593 / 00). Determined by the Biology section of "LABORATORIES OF QUALITY CONTROL, COSMETICS, FOOD AND DRUGS C.A.M.", within the framework of the conditions of the standards established in the test method "USP 23, PAG. 1721; TITULACION EPTON ”AWARD No O971103.003.

(16) TecPar - Award N ° 26.08.96 and N ° 52260-00014868). Determined by the Biology section of "LABORATORIES OF QUALITY CONTROL, COSMETICS, FOOD AND DRUGS C.A.M.", within the framework of the conditions of the standards established in the test method "USP 23, PAG. 1721; TITULACION EPTON ”AWARD No O971103.003. Non-irritating (BIOAGRI Laboratorios - Award No. RF-F34.592 / 00). Toxicological Classification IV: Practically Non-Toxic, Lethal Dose (LD50):> 4,000mg / kg weight (BIOAGRI Laboratories - Award N ° RF-F31.591 / 00).

(17) TecPar - Award N ° 26.08.96 and N ° 52260 00014870). Toxicological Classification IV: Practically Nontoxic, Lethal Dose (LD50):> 5,000mg / Kg.

(18) BIOAGRI Laboratorios - Award N ° RF-F111.590 / 00

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