Laboratoire MIDAC – 85 C, rue Nelson Mandela – 59120 LOOS/LILLE – FRANCE Tél : +33 (0)3 20 90 52 55 – contact@midac-lab.fr SAS au capital de 80 000 € - R.C.S. LILLE Métropole 329 303 242 Test report n° RE20-0677-2 Evaluation of the bactericidal activity according to the NF EN 13727 : 2015 standard Product : Processus global de lavage à froid, Générateur à ozone avec adjonction de produits lessiviel dédiés (Lavage N°7: Epidémie décontamination textile blanc) Batch : / On request of: GACHES CHIMIE SPECIALITES ACTIVITE ENTRETIEN TEXTILE 2 BIS CHEMIN DE LA SCIERIE FR 64800 OS MARSILLON Loos, 22 August 2020 The test report includes : 7 pages Copy of this test report is authorized only in its entirety. This report concerns only the tested product. LABORATOIRE MIDAC RE20-0677-2 Page 2 sur 7 I. PRINCIPLE : The bactericidal activity has been evaluated according to the NF EN 13727 standard: "Chemical disinfectants and antiseptics. Quantitative suspension test for the evaluation of bactericidal activity of chemical disinfectants for instruments used in the medical area. Test method and requirements (Phase 2, Step 1)." – December 2015. II. SAMPLE(S) IDENTIFICATION : Name(s): Processus global de lavage à froid, Générateur à ozone avec adjonction de produits lessiviel dédiés (Lavage N°7: Epidémie décontamination textile blanc) Machine OTEK 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: / Cool Star – Batch : 190422801 – Manufacture date: 29/08/2019 – Expiry date: / Hypochlorite de sodium 12.5% – Batch : 4200401 – Manufacture date: / – Expiry date: / Asepsis ultra – Batch : 3474210348707 – Manufacture date: / – Expiry date: / LABORATOIRE MIDAC RE20-0677-2 Page 3 sur 7 (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 2020 Storage conditions at the laboratory: Room temperature, in the darkness. Appearance of the product: Garosive deter is a green liquid, Asepsis ultra is a yellow liquid and the others products are colorless liquid. Product diluent recommended by the manufacturer: Undiluted. III. TEST METHOD AND ITS VALIDATION : - Neutralization method : Dilution Neutralization. - Diluent neutralizer : 14 g/L Sodium thiosulfate. IV. EXPERIMENTAL CONDITIONS : Period of analysis: from 02 July 2020 to 04 July 2020 Test organism(s): see table(s) on next page(s). Preservation and stock cultures of test organisms following the requirements of the EN 12353 standard. Diluent used for product test solution: Undiluted. Product test concentration(s): see table(s) on next page(s). Appearance of product dilutions: Colorless liquid for test 1 and unclear suspension for test 2 and 3. Stability of the test mixture interfering substance / test product(s): No precipitate. Test temperature: 20°C (± 1°C). Contact time: 7 minutes (± 10 seconds). Interfering substance(s): 3g/l bovine albumin with 3mL/L sheep erythrocytes (dirty conditions). Incubation temperature: 37°C (± 1°C). LABORATOIRE MIDAC RE20-0677-2 Page 4 sur 7 V. TEST RESULTS Control and validations of the dilution-neutralization method in the test conditions (carried out in parallel with tests) Conclusion: The method is validated in the test conditions. Souche(s) / Strain(s) Nombre de microorganismes / Enumeration of microorganisms (CFU/ml) Suspension de validation / Validation suspension Nv0 Suspension de validation / Validation suspension NvB Témoin des conditions expérimentales / Experimental conditions control A Témoin de neutralisation / Neutralizer control B Validation de la méthode de neutralisation / Method validation C Pseudomonas aeruginosa DSM 939 Vc1 : Vc2 : Nv0 : 78 82 80 Vc1 : Vc2 : NvB : 80 81 8.1x104 Vc1 : Vc2 : A : 72 81 76.5 Vc1 : Vc2 : B : 66 71 68.5 Vc1 : Vc2 : C : 70 70 70 Staphylococcus aureus DSM 799 Vc1 : Vc2 : Nv0 : 110 98 104 Vc1 : Vc2 : NvB : 113 112 1.1x105 Vc1 : Vc2 : A : 120 122 121 Vc1 : Vc2 : B : 118 114 116 Vc1 : Vc2 : C : 103 98 100.5 Enterococcus hirae DSM 3320 Vc1 : Vc2 : Nv0 : 71 84 77.5 Vc1 : Vc2 : NvB : 73 75 7.4x104 Vc1 : Vc2 : A : 90 78 84 Vc1 : Vc2 : B : 79 83 81 Vc1 : Vc2 : C : 81 82 81.5 Escherichia coli K12 DSM 11250 Vc1 : Vc2 : Nv0 : 139 143 141 Vc1 : Vc2 : NvB : 136 146 1.4x105 Vc1 : Vc2 : A : 150 148 149 Vc1 : Vc2 : B : 138 144 141 Vc1 : Vc2 : C : 151 148 149.5 Critères de validation / Validation criteria: Nv0 entre/between 30 et/and 160 CFU A, B et/ and C ≥ 0.5 x Nv0 B ≥ 0.0005 x NvB NvB entre/ between 3.0 x 104 et/and 1.6 x 105 C: testé à la concentration maximale / tested at maximum concentration LABORATOIRE MIDAC RE20-0677-2 Page 5 sur 7 Actual test results Souche(s) / Strain(s) Suspension d’essai /Test suspension N et/and N0 Nombre de microorganismes / Enumeration of microorganisms Na (CFU/mL) à la concentration testée / at the tested concentration (w/v) Test 1 Test 2 Test 3 Pseudomonas aeruginosa DSM 939 10-6 Vc1 : Vc2 : 10-7 Vc1 : Vc2 : N = N0 = log N0 = >330 >330 41 38 4.0x108 4.0x107 7.60 10-0 Vc1 : Vc2 : 10-1 Vc1 : Vc2 : Na : log Na : >330 >330 >330 >330 >3.3x104 >4.52 10-0 Vc1 : Vc2 : 10-1 Vc1 : Vc2 : Na : log Na : 0 0 0 0 <1.4x102 <2.15 10-0 Vc1 : Vc2 : 10-1 Vc1 : Vc2 : Na : log Na : 0 0 0 0 <1.4x102 <2.15 Staphylococcus aureus DSM 799 10-6 Vc1 : Vc2 : 10-7 Vc1 : Vc2 : N = N0 = log N0 = >330 >330 46 38 4.2x108 4.2x107 7.65 10-0 Vc1 : Vc2 : 10-1 Vc1 : Vc2 : Na : log Na : >330 >330 >330 >330 >3.3x104 >4.52 10-0 Vc1 : Vc2 : 10-1 Vc1 : Vc2 : Na : log Na : 0 0 0 0 <1.4x102 <2.15 10-0 Vc1 : Vc2 : 10-1 Vc1 : Vc2 : Na : log Na : 0 0 0 0 <1.4x102 <2.15 Enterococcus hirae DSM 3320 10-6 Vc1 : Vc2 : 10-7 Vc1 : Vc2 : N = N0 = log N0 = >330 >330 48 46 4.7x108 4.7x107 7.67 10-0 Vc1 : Vc2 : 10-1 Vc1 : Vc2 : Na : log Na : >330 >330 >330 >330 >3.3x104 >4.52 10-0 Vc1 : Vc2 : 10-1 Vc1 : Vc2 : Na : log Na : 0 0 0 0 <1.4x102 <2.15 10-0 Vc1 : Vc2 : 10-1 Vc1 : Vc2 : Na : log Na : 0 0 0 0 <1.4x102 <2.15 Escherichia coli K12 DSM 11250 10-6 Vc1 : Vc2 : 10-7 Vc1 : Vc2 : N = N0 = log N0 = >330 >330 40 43 4.2x108 4.2x107 7.62 10-0 Vc1 : Vc2 : 10-1 Vc1 : Vc2 : Na : log Na : >330 >330 >330 >330 >3.3x104 >4.52 10-0 Vc1 : Vc2 : 10-1 Vc1 : Vc2 : Na : log Na : 0 0 0 0 <1.4x102 <2.15 10-0 Vc1 : Vc2 : 10-1 Vc1 : Vc2 : Na : log Na : 0 0 0 0 <1.4x102 <2.15 LABORATOIRE MIDAC RE20-0677-2 Page 6 sur 7 Critères de validation / Validation criteria: N entre/between 1.5 x 108 et/and 5.0 x 108 N0 entre/between 1.5 x 107 et/and 5.0 x 107 log N0 entre/between 7.17 et/and 7.70 Réduction (R) du nombre de cellules viables à la concentration testée (m/v) : Reduction (R) of the number of viable cells at the tested concentration (w/v) : Souche(s) / Strain(s) Test 1 Test 2 Test 3 Pseudomonas aeruginosa DSM 939 log R : <3.08 log R : >5.45 log R : >5.45 Staphylococcus aureus DSM 799 log R : <3.10 log R : >5.47 log R : >5.47 Enterococcus hirae DSM 3320 log R : <3.15 log R : >5.52 log R : >5.52 Escherichia coli K12 DSM 11250 log R : <3.10 log R : >5.47 log R : >5.47 Critères d’interprétation/Interpretation criteria: concentration active si /active concentration if log R ≥ 5 concentration non active si /non active concentration if log R < 5 LABORATOIRE MIDAC RE20-0677-2 Page 7 sur 7 Number of repetitions : The test was carried out once. VI. CONCLUSION : According to the NF EN 13727 : 2015 standard, the product Processus global de lavage à froid, Générateur à ozone avec adjonction de produits lessiviel dédiés (Lavage N°7: Epidémie décontamination textile blanc) Batch : / possesses a bactericidal activity at Test 2 after 7 minutes (± 10 seconds) at 20°C (± 1°C) in contact with 3g/l bovine albumin with 3mL/L sheep erythrocytes (dirty conditions). VII. REVISION HISTORY Date Revision description Version n.a n.a n.a
