LABORATOIRE MIDAC RE21-0053-2Page 2 sur 9I.PRINCIPLEThe virucidal activity was determined according to the protocol of the NF EN 14476+A2 standard: "Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of virucidal activity in the medical area – Test method and requirements (phase 2, step 1)." - July 2019.II. IDENTIFICATION OF SAMPLE Name(s)(1):Processus global de lavage à froid, Générateur à ozone avec adjonction de produit lessiviels dédiés (Lavage N°4: Textile de type couleur souillé) Machine OTEK(1)Cool Star–Batch : 190422801 – Manufacture date : 29/08/2019 – Expiry date : / Garosive deter – Batch: 200080001 – Manufacture date : 24/02/2020 – Expiry date : /Garo boost – Batch : 200101601 – Manufacture date : 05/03/2020 – Expiry date : /Peracid forte – Batch : 200015501 – Manufacture date : 15/01/2020 – Expiry date : /(Mix of products made by the MIDAC Laboratory with the addition of products in the vertical direction from top to bottom) Society: GACHES CHIMIE SPECIALITES Received at the laboratory: 17 June 2020Storage conditions at the laboratory: Room temperature, in the darkness.Appearance of the product: Garosive deter is green liquid and others products are colorless liquid.Product diluent recommended by the manufacturer: Undiluted. LABORATOIRE MIDAC RE21-0053-2Page 3 sur 9III. EXPERIMENTAL CONDITIONS Period of analysis : 09 February 2021to25 February 2021 Product test concentrations : see table(s) on next page(s).Virus identification: Human coronavirus 229E (HCOV-229E), P1Cells identification: Name and source : HeLa , CCL-2 Number of passages :29Cell culture medium : MEM 10%SVF, 1% AANE, 1%ATB, 1%L-GluProduct diluents used : Distilled water.Appearance product dilutions :Essay 1 : Colorless homogeneous liquid Essay 2 : whitish homogeneous liquid Essay 3 : whitish homogeneous liquid Stability of mixture: None precipitate observed during the testTest temperature : 10°C (± 1°C).Contact times : 7 minutes (+/- 10 seconds) Interfering substances : 3g/l bovine albumin with 3mL/L sheep erythrocytes (dirty conditions)Method used for product neutralization : Microfiltration method- Columns: Microspin S-400 HR Incubation temperature : 37°C (± 1°C) and 5 % CO2 IV.RESULTSThe calculation of titer reductions is based on the method of Spearman and Kärber. It is measured as the difference between the titer of the virus control and the titer of product test solution.1.MethodvalidationAssays were validated by:- a cytotoxicity control - a sensitivity control of untreated cells - a formaldehyde internal standard control - a product neutralization control LABORATOIRE MIDAC RE21-0053-2Page 4 sur 9a) Product cytotoxicity Product cytotoxicity (log DICT50)Dilution method 3.50E+00Filtration on Microspin TMS-400 HR columns 1.50E+00Comment: after dilution according to the standard protocol, the cytotoxicity of the product is 3.50E+00 log DICT50. The filtration on Microspin TM S-400 HR columns leads to the reduction of the toxicity at1.50E+00 log DICT50.b) Cells sensitivity Sensitivity (log DICT50)Treated cells A6.13E+00Untreated cells B6.13E+00Comment: The difference between the virus titer of treated cells (A) and untreated cells (B) must be less than 1 log. c) Formaldehyde internal standard control ProductTest concentrationInterfering substanceViral titer in the test(log DICT50)Reduction(log DICT50)Formaldehyde – 30 min0.7% (v/v)PBS3.63E+002.37E+00Formaldehyde - 60 min0.7% (v/v)PBS3.38E+002.62E+00Viral control formaldehyden.aPBS6.00E+00Comment: The difference between the titer of the viral control, expressed as a logarithm, and the titer of the virus in the formaldehyde internal standard control is2.37E+00 log DICT50 after30min and 2.62E+00 log DICT50 after60min. LABORATOIRE MIDAC RE21-0053-2Page 5 sur 9d)NeutralizationcontrolProductTest concentrationInterfering substanceViral titer in the test(log DICT50)Reduction(log DICT50)Neutralization of the product Essay 3 3g/l bovine albumin with 3mL/L sheep erythrocytes (dirty conditions).6.25E+001.20E-01Neutralization controln.a6.13E+00Comment: Checking the efficiency of the neutralization of product activity, the difference of titer with the test suspension must be ≤ 0.5log.2. Test results: Evaluation of virucidal activity ProductTest concentrationInterfering substanceViral titer in the test (log DICT50)Reduction(log DICT50)Global cold washing process, ozone generator OTEK with the addition of dedicated detergents (Lavage n°4: Textile de type couleur souillé)(1)Essay 1 3g/l bovine albumin with 3mL/L sheep erythrocytes (dirty conditions).5.63E+006.20E-01Essay 2 1.50E+004.75E+00Essay 3 1.50E+004.75E+00Viral control T0 6.25E+00Viral control Tmax6.25E+00Comment: At least one concentration per test must show a reduction of 4log or more, and at least one concentration must show a log reduction of less than 4. LABORATOIRE MIDAC RE21-0053-2Page 6 sur 9V.CONCLUSIONAccording to NF EN 14476+A2: 2019 standard, The product Global cold washing process, ozone generator OTEK with the addition of dedicated detergents (Lavage n°4: Textile de type couleur souillé)(1)batch(1): /possesses a virucidal activity tested at Essay 2 after 7 minutes (+/- 10 seconds) at 10°C (± 1°C)with 3g/l bovine albumin with 3mL/L sheep erythrocytes (dirty conditions) againstHuman coronavirus 229E (HCOV-229E).VI.REMARKSThe COFRAC accreditation attests laboratories are competent for the only tests covered by the program.Copy of this test report is authorized only in its entirety. This report concerns only the tested product. (1) Data provided by the customer. Laboratoire MIDAC assumes no responsibility for the information provided by the customer VII.REVISIONDateRevision descriptionVersionn.an.an.a LABORATOIRE MIDAC RE21-0053-2Page 7 sur 9Annex1: Raw DataProduct(1): Global cold washing process, ozone generator OTEK with the addition of dedicated detergents (Lavage n°4: Textile de type couleur souillé) Batch(1):/ProductConcentrationInterfering substanceContact Time10-110-210-310-410-510-610-710-8Global cold washing process, ozone generator OTEK with the addition of dedicated detergents (Lavage n°4: Textile de type couleur souillé) CytotoxicityEssay 33g/l bovine albumin with 3mL/L sheep erythrocytes (dirty conditions)n.aTTTTTTTTTTTTTTTTTTTTTTTT0000000000000000000000000000000000000000Global cold washing process, ozone generator OTEK with the addition of dedicated detergents (Lavage n°4: Textile de type couleur souillé) Cytotoxicity after MicrospinEssay 3n.aTTTTTTTT00000000000000000000000000000000000000000000000000000000Sensitivity of treated cells Essay 360min4444444444444444333333332111212211111100111010110000000100000000Sensitivity of untreated cells n.aPBS60min4444444433333333222222222222222211122211010110110000000000000000Formaldehyde 30min0,7 % (v/v) 30min4444444444444444444444440001000000000000000000000000000000000000Formaldehyde 60min0,7 % (v/v) 60min4444444444444444404444440000000000000000000000000000000000000000Formaldehyde control n.a60min3333333333333333222222221111111110112111110101010000000000000000FormaldehydeCytotoxicity0.7%(v/v)n.aTTTTTTTT00000000000000000000000000000000000000000000000000000000Viral control n.a3g/l bovine albumin with 3mL/L sheep erythrocytes (dirty conditions)04444444433333333333333331111111111111011111010111000000000000000Viral control n.a7 minutes (+/- 10 seconds)3333333333333333222222221111111111111101110101110000000100000000Global cold washing process, ozone generator OTEK with the addition of dedicated detergents (Lavage n°4: Textile de type couleur souillé)Essay 17 minutes (+/- 10 seconds)3333333322222222111111111111111111100101011010100000000000000000Essay 24444444400000000000000000000000000000000000000000000000000000000Essay 34444444400000000000000000000000000000000000000000000000000000000InactivationEssay 330min4444444444444444444444443333333311111111101100110000010000000000Inactivation controln.a30min44444444333333333333333311111123101111111011101200000000000000001to 4 Presence of virus. 1 = 25% CPE and 4 = 100% CPE 0 Absence of virus T Toxicn.anon-applicable LABORATOIRE MIDAC RE21-0053-2Page 8 sur 9Annex2: Graphic presentation of the test resultsa)Reference inactivation of the virus by 0.7% (v/v) formaldehyde b) Evaluation of virucidal activity of the product 6,251,5012345670 min7 minlg DICT50Contact time Cytotoxicity of the tested productInactivation of the virus by the tested product63,633,3801234567030min60minlg DICT50Contact timeInactivationof the virus by 0,7%(v/v) formaldehydeCytotoxicity of 0,7% (v/v) formaldehyde LABORATOIRE MIDAC RE21-0053-2Page 9 sur 9Annex 3: Methodology verificationA test is only valid if the following criteria are fulfilled: a/ Test virus suspension has at least a concentration which allows the determination of a 4 log10 reduction of the virus titer. b/ The difference between the titer of the viral control, expressed as a logarithm, and the titer of the virus in the inactivation reference test is between -0,5 and -2,5 after 30min and between -2 and -4,5 after 60min for poliovirus, between -3 and -5 after 30min and -3,5 and 5,5 after 60min for adenovirus, between 0.0 and -2 after 30min and -0.5 and 2,5 after 60min for parvovirus,between -0.75 and -3,5 after 5min and between -2,0 and ≥ -4 after 15min for vaccina virus, between -1 and -3 after 30min and between -2,0 and -4,0 after 60min for murine norovirus c/ Cytotoxicity of the product does not affect cell morphology and growth or susceptibility for the test virus in the dilutions of the test mixtures which are necessary to demonstrate a 4log reduction of the virus. d/ Comparative titration of the virus on the treated cell cultures with dilutions of the test mixture and in parallel with PBS results in a difference <1 lg of the viral titer. e/ When checking the efficiency of the neutralization of product activity, the difference of titer with the test suspension must be ≤ 0.5log.f/ At least one concentration per test must show a reduction of 4log or more, and at least one concentration must show a log reduction of less than 4.
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