ADANTIUM® PLUS Disinfectant Concentrate Decontaminant- Single Dose 25 mL
Adantium ® Plus is a modern synthetic preparation, concentrated, for the simultaneous cleaning and disinfection with sterilizing action aimed at the total decontamination of heat-resistant surgical devices and surfaces in hospitals, according to the current safety law.
Disinfection time: 5' at 2.5% concentration and 10 minutes for 0.5% solutions. Acts on all microorganisms;
Exclusive action with total spectrum of activity (bacteria, yeasts, fungi and viruses) and exceptional rapidity of disinfection: bacteria, 5 minutes of action; spores and fungi, 10 minutes of action; virus, within 1 minute;
No residue after rinsing;
Effective even in the presence of organic matter. The use of hard water does not diminish its effectiveness;
Does not contain Peroxide: therefore ideal for disinfection with sterilizing action of the most delicate devices and of high economic value, as it is not corrosive to materials and compatible with thermolabile instruments;
The concentrated product has a stability/validity of 36 months when packaged intact and correctly stored;
Does not require activation as it is a single component. pH neutral.
Classification: Medical Device Class II a
Composition: Diphedac®, Surfactant Complex (composed of Alkyl Dimethyl Benzyl Ammonium Chloride), Solvents and Surfactants.
Mechanism of action: Adantium® Plus contains a new synthetic salt that, alone or resuspended with formulated, is able to effectively counteract the nuclease activity of the RNases present in the plasma, preserving the added synthetic RNAs from degradation. (see clinical validation Prof.Pistello) Adantium® Plus also protects the cellular RNAs from degradation by RNase A. In conclusion, based on experimental evidence obtained and in consideration of the high resistance to the physical-chemical inactivation of RNases, Adantium® Plus exerts an effective inhibitory role of these nucleases which, in the biological field, translates into an important role of containment/inactivation of viral replication. Special and unique characteristics: Adantium® Plus, unlike other disinfectant products currently available on the market, does not present any risk of co-carcinogenicity. This guarantees the use in total safety and compliance with the provisions of the Safety Law (Legislative Decree 81/08 as amended).
Indications: Decontamination of medical equipment and surfaces: Suitable for all types of surgical instruments and medical devices, medical equipment and equipment, surfaces, walls and semi-mobile equipment.
Incompatibility: Do not mix the product with substances other than water.
Method of use: The product can be used to carry out a simultaneous and effective cleaning and decontamination of potentially infected instruments, surfaces and medical equipment (a safety measure aimed at protecting operators from biological risk). The solutions prepared by diluting the contents of the 25 ml single-dose bottle in 1 litre of demineralised water and kept in clean, closed containers remain active for 20 days.
Concentration at 2.5%: – Instrument and medical equipment: Contact time 5 minutes – Solution active 20 days. – Pour Adantium® Plus – 25 ml single-dose Schering bottle into a 1Lt container – Insert demineralized or pure water to a volume of one liter. – The solution is ready to be used with the Hygienic System.
– Cleaning / Disinfection of floors, operating room walls, surfaces and semi-mobile equipment : Contact time 1 minute – Pour Adantium® Plus – 25 ml single-dose Schering bottle into 1Lt container – Insert demineralized or pure water up to 1 litre volume. – The solution is ready to be used with the Hygienic System. – RINSING IS NOT NECESSARY
Residue after rinsing:
A gas chromatography study of treatments on glass, PVC and stainless steel shows that 99.5% of the active ingredient is present in the first rinse water.
Biodegradability: Biodegradable over 94%, according to OECD 301 BDCO in concentration at 2.5%: 19.5. BOD in concentration at 2.5%: <5.
Stability: A study on the stability of active ingredients and biological activity according to EN 13610 reports a validity of 36 months. Studies: – Department of Chemistry, University "La Sapienza" – Rome: Study Title: Stability study of high level disinfectant medical device class IIa Adantium Plus Toxicity: Low toxicity: (LD 50 rat oral: ~2,000 mg/kg).
Studies: RTC – Research Toxicology Centre, Rome: Title of Study: "Adantium Plus – Acute dermal irritatio study in the rabbit – Final Report (RTC Study No: 8931-1); RTC – Research Toxicology Centre, Roma:
Study Title: "Adantium Plus – Acute dermal irritatio study in the rabbit – Final Report (RTC Study No: 8931-1); RTC – Research Toxicology Centre, Rome: Study Title: "Adantium Plus – Single dose oral toxicity study in the rat – Final Report (RTC Study No: 16880-1); A. Pavan; Dipartimento Medicina Sperimentale, Università degli Studi "L'Aquila": Title of the Study: "Evidence of acute dermal irritation and sensitization after application of Adantium Plus (in compliance with the standards described by OECD guidelines N° 404 and N° 410 and ISO 10993).
Traceability: The complete traceability of the batches, from the acceptance of the raw materials to the distribution of the finished product, is carried out according to the procedures of the internal quality system.
EN 14885 The bibliography concerning the Adantium range has been updated in compliance with EN14885 "Chemical antiseptics and disinfectants Application of European Standards concerning chemical antiseptics and disinfectants" which reports the tests to be carried out according to the specific sector of use of the disinfectant.
Clinical validation: Prof. Mauro Pistello; Department of Experimental Pathology Medical Biotechnology Infectivology and Epidemiology. University of Pisa: Title of the Study "Assay for inhibiting/denaturing activity of proteins and enzymes contained in biological fluids with medical devices designed to degrade the RNA nucleic acid contained in cells, bacteria and HIV E HCV viruses" Evaluation of the in vitro anti-microbial activity of Adantium® Plus in the prevention of infections acquired in hospital: The data show that Adantium® Plus has demonstrated excellent anti-microbial activity; a reduction of > 5 logarithms in 5 minutes of action time was observed in many strains normally present in hospitals, frequently associated with nosocomial infections.
Bactericidal activity – Prof. Massimo Clementi; University Vita-Salute, San Raffaele – Milan: "Bactericidal activity of the disinfectant formulation ADANTIUM® PLUS. Quantitative test on substrate" (EN 14561:2006); Results: Pseudomonas aeruginosa ATCC 15442 on support: 0.5% reduction >5 logarithms in 10 minutes of action; Pseudomonas aeruginosa ATCC 15442 on support: 2.5% reduction >5 logarithms in 5 minutes of action.
– Prof. Massimo Clementi; University Vita-Salute, San Raffaele – Milan: "Bactericidal activity of the disinfectant formulation ADANTIUM® PLUS". (EN 13727:2003);
Results: Escherichia coli ATCC 10356: at 2.5% reduction >5 logarithms in 5 minutes of action; Pseudomonas aeruginosa ATCC 15442: at 2.5% reduction >5 logarithms in 5 minutes of action; Enterococcus hirae ATCC 10541: at 2.5% reduction >5 logarithms in 5 minutes of action; Escherichia coli ATCC 10356: 0.5% reduction >5 logarithms in 10 minutes of action; Pseudomonas aeruginosa ATCC 15442: 0.5% reduction >5 logarithms in 10 minutes of action; Enterococcus hirae ATCC 10541: 0.5% reduction >5 logarithms in 10 minutes of action;
U.S. Labs in collaboration with the Jacaroni Diagnostic Center: Title of the Study: "DETERMINATION OF DECONTAMINATION PROCESS WITH HIGH LEVEL ADANTIUM PLUS DISINFECTANT IN HYGIENE MACHINE" (UNI EN ISO 11737-1:2006)
Virucidal activity – Prof. Massimo Clementi; University Vita-Salute, San Raffaele – Milan: "Virucidal activity of the disinfectant formulation ADANTIUM® PLUS". (EN 14476:2005);
Results: Poliovirus 1: at 2.5% reduction >5 logarithms in 5 minutes of action; Adenovirus type 5: at 2.5% reduction >5 logarithms in 5 minutes of action Poliovirus 1: at 0.5% reduction >5 logarithms in 10 minutes of action; Adenovirus type 5: 0.5% reduction >5 logarithms in 10 minutes of action; The formulation made with the active ingredient Diphedac® has been tested for viral inactivation under ambient temperature conditions in a single time of three minutes in the presence of fetal bovine serum at 5%: GLP studies conducted according to U standards. S. Enviromental Protection Agency regarding the characterization and stability of the compound on the following viral cells: – Human Coronavirus ATCC VR-740, Strain 229E – Herpes Simplex virus type ATCC VR734, Strain – Human Influenza A-type 1-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 55120 – USA. All formulations have full viral inactivation properties within 3 minutes.
Fungicide activity: – Prof. Massimo Clementi; Università Vita-Salute, San Raffaele – Milan: "Fungicide activity of the disinfectant formulation ADANTIUM® PLUS". (EN 13624:2005);
Results: Escherichia coli ATCC 10356: at 2.5% reduction >5 logarithms in 5 minutes of action; Pseudomonas aeruginosa ATCC 15442: at 2.5% reduction >5 logarithms in 5 minutes of action; Enterococcus hirae ATCC 10541: at 2.5% reduction >5 logarithms in 5 minutes of action; Escherichia coli ATCC 10356: 0.5% reduction >5 logarithms in 10 minutes of action; Pseudomonas aeruginosa ATCC 15442: 0.5% reduction >5 logarithms in 10 minutes of action; Enterococcus hirae ATCC 10541: 0.5% reduction >5 logarithms in 10 minutes of action;
U.S. Labs in collaboration with the Jacaroni Diagnostic Center: Title of the Study: "DETERMINATION OF DECONTAMINATION PROCESS WITH HIGH LEVEL ADANTIUM PLUS DISINFECTANT IN HYGIENE MACHINE" (UNI EN ISO 11737-1:2006)
Virucidal activity – Prof. Massimo Clementi; University Vita-Salute, San Raffaele – Milan: "Virucidal activity of the disinfectant formulation ADANTIUM® PLUS". (EN 14476:2005);
Results: Poliovirus 1: at 2.5% reduction >5 logarithms in 5 minutes of action; Adenovirus type 5: at 2.5% reduction >5 logarithms in 5 minutes of action Poliovirus 1: at 0.5% reduction >5 logarithms in 10 minutes of action; Adenovirus type 5: 0.5% reduction >5 logarithms in 10 minutes of action; The formulation made with the active ingredient Diphedac® has been tested for viral inactivation under ambient temperature conditions in a single time of three minutes in the presence of fetal bovine serum at 5%: GLP studies conducted according to U standards. S. Enviromental Protection Agency regarding the characterization and stability of the compound on the following viral cells: – Human Coronavirus ATCC VR-740, Strain 229E – Herpes Simplex virus type ATCC VR734, Strain – Human Influenza A-type 1-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 55120 – USA. All formulations have full viral inactivation properties within 3 minutes.
Fungicide activity: – Prof. Massimo Clementi; Università Vita-Salute, San Raffaele – Milan: "Fungicide activity of the disinfectant formulation ADANTIUM® PLUS". (EN 13624:2005);
Results in dirty conditions: Candida albicans ATCC 10231 on support: 0.5% reduction >5 logarithms in 10 minutes of action; Aspergillus niger ATCC 16404 on support: 0.5% reduction >5 logarithms in 10 minutes of action; Candida albicans ATCC 10231 on support: 2.5% reduction >5 logarithms in 5 minutes of action; Aspergillus niger ATCC 16404 on support: 2.5% reduction >5 logarithms in 5 minutes of action;
– Prof. Massimo Clementi; University Vita-Salute, San Raffaele – Milan: "Fungicidal activity of the disinfectant formulation ADANTIUM® PLUS. Test Quantity on support" (EN 14562:2006);
Results in dirty conditions: Candida albicans ATCC 10231: at 0.5% reduction 4 logarithms in 10 minutes of action; Aspergillus niger ATCC 16404: at 0.5% reduction >4 logarithms in 10 minutes of action; Candida albicans ATCC 10231: at 2.5% reduction >4 logarithms in 5 minutes of action; Aspergillus niger ATCC 16404: at 2.5% reduction >4 logarithms in 5 minutes of action.
Mycobactericide activity:
– Prof. Massimo Clementi; University Vita-Salute, San Raffaele – Milan: "Mycobactericidal activity of the disinfectant formulation ADANTIUM® PLUS". (EN 14348:2005);
Assays performed in dirty and clean conditions: Mycobacterium avium ATCC 15769: at 2.5% reduction >5 logarithms in 5 minutes of action; Mycobacterium terrae ATCC 15755: 2.5% reduction >5 logarithms in 5 minutes of action; Mycobacterium avium ATCC 15769: 0.5% reduction >5 logarithms in 10 minutes of action; Mycobacterium terrae ATCC 15755: 0.5% reduction >5 logarithms in 10 minutes of action.
Sporicidal activity: – Prof. Massimo Clementi; University Vita-Salute, San Raffaele – Milan: "Sporicidal activity of the disinfectant formulation ADANTIUM® PLUS". (EN 14347:2005); Based on the experimental conditions and interpretation criteria provided by European Standard EN 14347:2005, Adantium® Plus showed sporicidal activity in 10 minutes at 2.5% dilution and a spore reduction of 3log10 already at 0.5% dilution. Warnings: The European guidelines of the EC 88/379 concerning dangerous preparations and the Italian Ministry of Health require some attention when treating the
produced according to the following.
(H) Risk phrases: Eye Irrit. 2: H319 – Causes severe eye irritation. Flam. Liq. 3: H226 – Flammable liquid and vapours. Skin Irrit. 2: H315 – Causes skin irritation. Skin Sens. 1A: H317 – May cause allergic skin reaction. Acquatic Acute 1: H400 – Highly toxic to aquatic organisms.
(P) Precautionary statements:
P303+P361+P353: IF ON SKIN (or hair): Remove all contaminated clothing immediately. Skin rinse/shower.P272: Contaminated work clothes should not be taken out of the workplace. P305+P351+P338: IF ON EYES: Rinse thoroughly for several minutes. Remove any contact lenses if it is easy to do so. Continue to rinse. P273:Do not disperse into the environment. P397:Remove spilled material. P332+P313: In case of skin irritation: seek medical advice. P362: Take off contaminated clothing and wash before re-use. P370+P378: In case of fire: use ABC powder extinguisher to extinguish. P501: Dispose of contents/container to hazardous or special waste collection points.
|
