WHY CHOSE ADANTIUM PLUS

Transcription

1 WHY CHOSE ADANTIUM PLUS

2 Therefore, to make the choice of disinfectant it should be taken into account these three main characteristics: 1. Microbial Reduction Spectrum A specific Disinfectant only for some biological agents, does not guarantee complete protection, on the contrary, it facilitates the spread of resistant agents thereto in the healthcare environment. The disinfectant should then be effective against all biological agents identified as factors of risk in healthcare / hospital activity. Consequently, it must accomplice with all applicable technical standards in relation to these risk factors. So, it will be chosen and used only those disinfectants that comply with industry standards issued by the CEN (European Committee for Standardization). These are: The three main characteristics of ADANTIUM PLUS 1. ADANTIUM PLUS is a disinfectant of last generation for reduction of reduction of the complete spectrum Adiantum Plus has all the characteristics in performance required by the CEN (European Committee for Standardization) in order to be considered an adequate measure of protection against biological hazards. Full compliance with all requirements of CEN legislation can be seen in the following charts: EN 13727:2003 Chemical disinfectants and antiseptics. Quantitative test on suspension for the evaluation of bactericidal activity of chemical disinfectants for instruments used in the chemical area. Test method and requirements (phase 2 / step 1) Expected result: red. 5 log

3 EN 13624:2003 Chemical disinfectants and antiseptics. Quantitative test on suspension for the evaluation of fungicidal activity of chemical disinfectants for instruments used in the chemical area. Test method and requirements (phase 2 / step 1) Expected result: red. 5 log EN 14347:2005 Chemical disinfectants and antiseptics. Basic sporicidal activity. Test method and requirements (phase 1 / Step 1) Expected result: red. 3 log EN 14348:2005 Chemical disinfectants and antiseptics. Quantitative test on suspension for evaluation of mycobactericidal activity of chemical disinfectants in the medical sector including instrument disinfectants. Test method and requirements (phase 2 / step 1) Expected result: red. 5 log EN 14476:2005 Chemical disinfectants and antiseptics. quantitative test on suspension for Virucidal activity of chemical disinfectants and antiseptics used in human medicine. Test method and requirements (phase 2 / step 1) Expected result: red. 4 log

4 EN 14561:2006 Chemical disinfectants and antiseptics. Quantitative transfer test for the evaluation of bactericidal activity for instruments used in the medical sector. Test method and requirements (Phase 2 / Step2) Expected result: red. 5 log EN 14562:2006 Chemical disinfectants and antiseptics. Quantitative transfer test for evaluation of fongicide or yeasticidal of instruments used in the medical sector. Test method and requirements (Phase 2 / Step 2) The formulation of the disinfectant under evaluation is tested under both clean and dirty different conditions, and even with the presence of interfering agents.

5 2. The toxicity of staff and patients exposure It must only be chosen and used non-toxic disinfectants. in fact, the implementation of a protection system for any given risk should not cause another! 2. Adantium Plus presents total absence of toxicity Thanks to its mechanism of action, this formulation can be used at very low concentrations, so as not to be of any toxicity for any person exposed in the environment of use. Researhs: RTC - Toxicology Research Center, Rome: Title of Study: "Adiantum Plus - acute skin irritation study in the rabbit - Final Report (RTC Study Number: ); RTC - Toxicology Research Center, Rome: Title of Study: "Adantium Plus Study of toxicity by single oral dose in rats - Final Report(RTC Study No ); Pavan; Department of Experimental Medicine, University of "El Águila": Title of Study: " Evidence of acute dermal irritation and sensitization after application of Adantium Plus (according to the rules set by the OECD guidelines N 404 e N 410 ed ISO 10993). Unique and specific features: Adiantum Plus, differs from other products with disinfecting activity currently available on the market, in that it has no risk of co-carcinogenicity. That ensures its safely use and it is in accordance with the provisions of the Security Law (Legislative Decree no. 81/08 and sm).

6 3. Environmental impact The choice of disinfectants with high rates of toxic substances should be avoided as they cannot be disposed of in sewer system. And moreover, it will be necessary to avoid those that, due to their unproven microbicide efficiency, may lead to a further and higher biological risk during disposal operations, so as to classify it as "rejected by infective risk" 3. Adiantum Plus is over 94% biodegradable study of gas chromatography in relation to treatments on glass, plastic and stainless steel shows that 99.5% of the active ingredient is present in the first rinsing water, so the preparation Adantium leaves no residue on surfaces or equipment. Notice that this preparation, in spite of having bacteriostatic activity after 18/24 hours, is no longer present on the surfaces after this time. Besides It is designed to eliminate the risk of resistant strains. These strains are in fact formed because traditional disinfectants contain in its formulation permanent residual substances, in small traces, though, that generate phenomena of vestiges of accumulation and adaptation of some strains, which begin to promote and increase their resistance

7 THE INNOVATION The main feature of Adantium Plus is that is their unique mechanism of action: This is a kind of high molecular kinetics, which leads to total biodegradation of even minute cell structures, such as RNA, which ensures a real prevention. Considering this new last generation technology, FIS & DM synthesize new substances (eg Diphedac) capable of releasing strong steric energies *. When a chemical bond is opened or broken, useful energy of the steric type is released, it is of more or less force on quantum basis determined by stoichiometric calculations; the values are higher due to the increased presence of CH bonds (Aceticidi adamantane acetoxy derivative) which means an energy of 100 kcal * So is the case of the synthesis of salt Diphedac, having numerous CH2 bonds, more than any other salt, specific disinfectant formulations can be structured and prepared with small amounts of the chemical in comparison with existing products on the market, providing protection against biological and chemical risk and minimal environmental impact, and this means maximizing while obtaining resultswww.hygienio.com info@hygienio.com

8 COMPOSITION New salt Diphedac gets a high bacterial reduction and rapid degradation of viral RNA in a time of 1 to 3 minutes, validated by means of test in vitro on suspension; the shortest exposure time and the least amount of chemical makes of it a particularly safe device. This is 'Adantium Plus composition - Diphedac 2,4 g - Ammonium Chloride Alkyl dimethyl benzyl 6 g - Isopropyl Alcohol 10 g - Essential oils 0,1 g - Colorants 0,003 g solvents and surfactants q.s. 100

9 COMPONENT ACTION Diphedac: Alkyl dimethyl benzyl Ammonium Chloride This is a new synthetic salt, which counteracts the activity of the RN nuclease present in the plasma, while preserving RNA causing its synthetic degradation, based on the experimental evidence obtained in the Center of Retrovirus, in its Experimental Virology and Pathology section of the microbiologic Institute "Santa Ana" in the University of PIsa, and considerating the physical and chemical resistance to inactivation of the RNase, Adantium Plus plays an inhibitory role of these nucleases which, in biological field, results a significant role in containment / inactivation of viral replication in a time of 1 to 3 minutes Alkylations of sulfuric group (damage to the permeability of the membrane) Isopropyl Alcohol Reaction: Sn1 + X and Sn2, this preparation performs an oxidation reaction to obtain a carbonyl compound bind to salt Diphedac Sodium hydroxide Sodium hydroxide gives a slight alkalinity to the solution, improving its effectiveness. Molecular dynamics of the mechanism of action In order to explain further the mechanism of action of its original synthesis, there should be some information on the molecular mechanics and the type of characteristic energy of the molecule. Steric = Stretch + Flex + Torsion Steric energy is a force of useful energy, but among them, the most important is the energy of torque, which employs a rotation angle of 180 to 360

10 In our case, in the field of chemical disinfectant solutions, the energy of torsion is the most useful as an active ingredient to maintain stable solution (present) over time and express a small and efficient energy; Therefore, only by providing a preparation with orders of links able to release torsional energy from 180 to 360 and in combination, that is, conjugated between two molecules, are able in turn to release energy bond dissociation (in all relative heat of formation of atoms involved). Eg having a CH bond dissociation energy of about 100 kcal mol. In the synthesis used, based on Adamantino acetic acid, an expansive cycle stabilized by CH 2 links and acetyl ion I is present so as to making the synthesis stable.

11 Degradazione di RNasi plasmatico HCV HIV in liquidi biologici We assessed the ability to denature enzymes responsible for degrading the RNA contained in the cells, bacteria and viruses, and that are particularly stable and resistant to RNase degradation. Samples containing RNA in plasma and RNase were incubated in absence or presence of the compounds of US Laboratories. After extraction of nucleic acid, the number of RNA molecules has been measured and remained intact. Results show that the RNA remains intact (loss <5%) in the presence of salts synthesis. Considering the high resistance to inactivation of RNase, it is believed that these compounds exert an effective inhibitor of RNase paper, and this means an effective inhibition of viral replication SAMPLE N of RNA copies estimated at a real-time RT-PCR Loss of positive control (%) Positive control2 8.9 x 10 4 < 5% Negative Control x Diphedac + C15 + Att 8.5 x Triadanol -3 + C15 + Att 8.6 x In summary: RNase enzymes are present in serum and in mucous membranes, made out of different proteins, but close together with a high stability. They are dissolved in aqueous solution, in fact, they become denatured when subjected to prolonged boiling (30 minutes) or autoclaving at 121 C, for over 20 minutes, but reborn rapidly recovering full functionality when the temperature returns to be below 70 C. they can be permanently inactivated by sterilization in an oven at 200 C for 4 h by chaotropic agents, isothiocyanate or guanidinehydrochloride at high concentrations difficult to handle in the field of disinfection. This resistance to denaturation of RNase is exploited by viruses to carry out an action of viral replication in the host cell genome and issue part of his infecting genome Indeed, counteract ing nuclease activity of plasma RNase with an SPECIFIC disinfectant is equivalent to an effective containment / inhibition of viral replication.

12 Antimicrobial activity 1) Bactericide Ability to reduce suspensión in 6 logs (EN 1276), surface test (EN 13697) in the presence of interfering substances that simulate dirty conditions. The strains tested are important pathogens responsible for serious infections in the hospital setting (urinary tract infections, infections of the lower respiratory tract and bacteremia). At a concentration of 2.5%, it has excellent mycobactericidal activity, reducing the concentration of 5 log of suspensions of Mycobacterium (avium, terrae and smegmatis) in a contact time of 5 minutes (EN 14937), even in the presence interfering substances. - Prof. Massimo Clementi; Universita Vita-Salute San Raffaele - Milan (EN 14561: 2006) "bactericide activity of the disinfectant formulation PLUS ADANTIUM amount of supporting evidence. Results: Pseudomonas aeruginosa ATCC of support: 0,5% reduction of> 5 logs n 10 minutes of action; Pseudomonas Aeruginosa ATCC of support: 2.5% reduction of> 5 logs in 5 minutes of action. - Prof. Massimo Clementi: University Vita-Salute San Raffaele - Milan: "bactericide activity of the disinfectant formulation ADANTIUM PLUS" (EN 13727: 2003); Results: Escherichia coli ATCC 10356: 2.5% reduction of> 5 logs in 5 minutes of action; Pseudomonas aeruginosa ATCC 15442: 2.5% reduction of> 5 logs in 5 minutes of action; Enterococcus hirae ATCC : 2.5% reduction of> 5 logs in 5 minutes of action; Escherichia coli ATCC 10356: 0,5% reduction of> 5 logs in 10 minutes of action; Pseudomonas aeruginosa ATCC 15442: 0,5% reduction of > 5 logs in 10 minutes of action; Enterococcus hirae ATCC : 0,5% reduction of > 5 logs in 10 minutes of action;

13 2) Fungicide In the testing report (EN 13697)it is showed a good fungicidal activity against C. albicans and Aspergillus niger at a concentration of 2.5%, in a contact time of 5 minutes even in dirty conditions) - Prof. Massimo Clementi; Universita Vita-Salute San Raffaele - Milan: "fungicidal activity of the disinfectant formulation ADANTIUM PLUS" (EN 13624: 2005); The results in dirty conditions: Candida albicans ATCC 10231, of support: 0,5% reduction of > 5 logs in 10 minutes of action; Aspergillus niger _ATCC of support: 0,5% reduction of > 5 logs in 10 minutes of action; Candida albicans ATCC of support: 2.5% reduction of > 5 logs in 5 minutes of action; Aspergillus niger ATCC of support: 5% reduction of > 5 logs in 5 minutes of action; - Prof. Massimo Clementi: Universita Vita-Salute San Raffaele - Milan: "fungicidal activity of the disinfectant formulation ADANTIUM PLUS quantitative test support." "(EN 14562: 2006) The results in dirty conditions: Candida albicans ATCC 10231: 0,5% reduction of > 4 logs in 10 minutes of action; Aspergillus niger ATCC 16404: 0,5% reduction of > 4 logs in 10 minutes of action; Candida albicans ATCC 10231: 2.5% reduction of > 4 logs in 5 minutes of action Aspergillus niger ATCC 16404: 2.5% reduction of > 4 logs in 5 minutes of action

14 3) Sporicide In suspension test (EN 13704) it is active against B. subtilis, B. cereus, Clostidium sporogenes at a concentration of 2.5% in a contact time of 10 minutes - Prof. Massimo Clementi: Vita-Salute San Raffaele - Milan: "Activity sporicidal disinfectant formulation ADANTIUM PLUS." (EN 14347: 2005); Based on the experimental conditions and performance criteria set by the European standard EN 14347: 2005, Adantium Plus showed sporicidal activity in 10 minutes at a dilution of 2.5% and a reduction of spores of 3 logs at a dilution of a 0.5% 4) Virucidal GLP studies in the ATS LABS, St. Paul, Minnesota, SS120, USA have validated Adantium inhibitory activity against HIV, HBV, HCV, HSV-1 and HSV-2 in an exposure time of 3 minutes at room temperature. - Prof. Massimo Clementi: Vita-Salute San Raffaele - Milan: "Activities ADANTIUM PLUS virucidal disinfectant formulation." (EN 14476: 2005) Results: Poliovirus 1: 2.5% reduction of > 5 logs in 5 minutes of action; Adenovirus tipo 5: 2.5% reduction of > 5 logs in 5 minutes of action;. Poliovirus 1: 0,5% reduction of > 5 logs in 10 minutes of action; Adenovirus tipo 5: 0,5% reduction of > 5 logs in 10 minutes of action; The formulation made with the active ingredient Diphedac has been tested for viral inactivation at room temperature conditions in only three minutes in the presence of fetal bovine serum %%: GLP studies conducted in accordance with standards established by the United States Environmental Protection Agency in relation to the characterization and stability of the compound on viral cells following: - Human Coronavirus ATCC VR-740, Strain 229E - herpes simplex virus type ATCC VR734, Strain - Human influenza tipo1- hepatitis C - B - human immunodeficiency virus type 1 (HIV) Study Directory: Mary J. Miller Douglas G. Anderson Karen M. Ramm Jennifer Palmen Tonia Bevers ATS LABS Saint. Paul, MN USA All formulations have properties of complete viral inactivation during the 3 minutes

15 3) Mycobactericidal - Prof. Massimo Clementi; Vita-Salute San Raffaele - Milan: "Adiantum PLUS disinfectant formulation mycobattericida Activities" (EN 14348: 2005) Tests under dirty conditions and clean conditions Mycobacterium avium ATCC 15769: 2.5% reduction of > 5 logs in 5 minutes of action; Mycobacterium terrae ATCC 15755: 2.5% reduction of > 5 logs in 5 minutes of action; Mycobacterium avium ATCC 15769: 0,5% reduction of > 5 logs in 5 minutes of action; Mycobacterium terrae ATCC 15755: 0,5 reduction of > 5 logs in 5 minutes of action

16 Additional advantages of the formulation ADIANTUM PLUS Extract from the brochure / technical data sheet: - Compatible with heat sensitive components - Efficient in the presence of organic substances - The use of hard water does not diminish the effectiveness - Reduction of bio chemical hazard (non toxic) - Hardly irritant in aqueous solution - Non-corrosive to materials - The solutions prepared with demineralized water and with demineralised water and stored in closed containers remain active for 20 days - Stability 36 months Conclusions A disinfection procedure is considered suitable for the intended purpose if it is effective against biological agents that are or may be the source of infection or infections. In that sense, it must be used those disinfectants that have the microbicidal activity that is required, but it should also be taken into account the operational context in which they are used and of course in the first place, those factors that possibly * interfere with proper operation * This fact may largely cancel or reduce its microbicidal activity. It is also fair to put some prudence in the choice of the compounds or formulations, taking into account the characteristics of toxicity as for those who are exposed during its use. In fact, disinfection is a security measure aimed at biological risk management So, who is going to pick and choose compounds or formulations, is bound not only to check if they demonstrate unequivocally its specific efficiency (microbicide), but also if there are overt toxicity exposure in use.

17 Bibliography Ortaggi A., Giuliano A., University La Sapienza Rome: Morphological study of scanning electron microscopy (SEM, VP 1450) on components of instruments thermolabile flexible treated Adantium Plus; Varian TLD Eurochem - M. Faga et al.: Analytical method HPLC for determination of Adamantanacetico in high-level disinfectant Adantium Plus; Department of Chemistry, University La Sapienza Rome: Study of Stability of high-level disinfectant medical device Class IIa Adantium Plus; M. Pistello; Centre on Retrovirus. Virology and Experimental Pathology Section. Institute of Microbiology, University Sant Anna in Pisa: Report on the results obtained from the analysis conducted on samples of Sali newly synthesized crystal pure hygroscopic»; RTC Toxicology Research Centre, Rome: Adantium Plus Acute dermal irritation study in the rabbit - Final Report (RTC Study No: ); RTC Toxicology Research Centre, Rome:: study entitled: Adantium Ambra Assessment of cellular toxicity by agarose overlay Final Report (RTC Study No: M ); RTC Toxicology Research Centre, Rome:: study entitled: Adantium Plus Single dose oral toxicity study in the rat Final Report (RTC Study No: ); A. Pavan; Department of Experimental Medicine, University of L Aquila : Tests for irritation and acute dermal sensitization after applying Adantium Plus (according to the standards outlined by the OECD guidelines # 404 and # 410 and ISO 10993); Prof. Giovanni Fadda; Catholic University of Sacro Cuore Rome: Test for the evaluation of the bactericidal and fungicidal activity of Adantium Plus in quantitative suspension in relation to the European standards with interagent substance. (EN 1276); Prof. Giovanni Fadda; Catholic University of Sacro Cuore Rome: Assessement of antimicrobial activity of Adantium Plus. (EN 1276 and EN 1650); Prof. Giovanni Fadda; Catholic University of Sacro Cuore Rome: Evaluation of the antifungal activity of Adantium Plus. (EN 13697); ATS Labs, 2540 Executive Drive SL Paul, MN 55120: Virucidal Efficacy of a Disinfectant for Use on Inanimate Environmental Surfaces Virus: Human Coronavirus; ATS Labs, 2540 Executive Drive SL Paul, MN 55120: Virucidal Efficacy of a Disinfectant for Use on Inanimate Environmental Surfaces Virus: Human Immunodeficiency Virus Type 1; ATS Labs, 2540 Executive Drive SL Paul, MN 55120: Virucidal Efficacy of a Disinfectant for Use on Inanimate Environmental Surfaces Virus: Herpes Simplex Virus type 2; ATS Labs, 2540 Executive Drive SL Paul, MN 55120: Virucidal Efficacy of a Disinfectant for Use on Inanimate Environmental Surfaces Virus: Bovine Viral Diarrhea virus as a surrogate for Human Hepatitis C virus; Prof. Massimo Clementi; University Vita-Salute, San Raffaele - Milan: Bactericidal activity of the disinfectant formulation ADANTIUM PLUS (EN 13727:2003); Prof. Massimo Clementi; University Vita-Salute, San Raffaele - Milan: Bactericidal activity of the disinfectant formulation ADANTIUM PLUS. Quantity Test of support (EN 14561:2006); Prof. Massimo Clementi; University Vita-Salute, San Raffaele - Milan: Fungicidal activity of the disinfectant formulation ADANTIUM PLUS. Quantity Test of support (EN 14562:2006); Prof. Massimo Clementi; University Vita-Salute, San Raffaele - Milan: Fungicidal activity of the disinfectant formulation ADANTIUM PLUS (EN 13624:2003); Prof. Massimo Clementi; University Vita-Salute, San Raffaele - Milan: mycobactericidal activity of the disinfectant formulation ADANTIUM PLUS (EN 14348:2005); Prof. Massimo Clementi; University Vita-Salute, San Raffaele - Milan: Sporicidal activity of the disinfectant formulation ADANTIUM PLUS (EN 14347:2005); Prof. Massimo Clementi; University Vita-Salute, San Raffaele - Milan: Virucidal activity of the disinfectant formulation ADANTIUM PLUS (EN 14476:2005)

18 Comparison with other Disinfectants COMPARISON WITH OTHER DISINFECTANTS PROPERTIES Aldehydes Hypochlorite NaDCC Alcohols QUACs Synthetics phenols Clorexidina Peracetic acid ADANTIUM PLUS TOTAL SPECTRUM RNA DEGRADATION SPEED OF ACTION CLEANING AND ISINFECTION PERSONAL SAFETY - +/- +/ EQUIPMENT SAFETY +/ MULTIPLE USE RESISTANCE TO ORGANIC MATERIAL EASY TO USE - +/- +/

19