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° RE20-0671-2 Evaluation of the bactericidal activity according to the protocol of the NF EN 13727 : 2015 standard Product : Processus global de lavage à froid, Générateur à ozone avec adjonction de produits lessiviels dédiés (Lavage N°1: Textile de type laine) Batch : / On request of: GACHES CHIMIE SPECIALITES ACTIVITE ENTRETIEN TEXTILE 2 BIS CHEMIN DE LA SCIERIE FR 64800 OS MARSILLON Loos, 21 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 RE20-0671-2 Page 2 sur 7 I. PRINCIPLE : The bactericidal activity has been evaluated according to the protocol of 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 lessiviels dédiés (Lavage N°1: Textile de type laine) Machine OTEK Garosive deter – Batch: 200080001 – Manufacture date : 24/02/2020 – 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 2020 Storage conditions at the laboratory: Room temperature, in the darkness. Appearance of the product: Garosive deter is green liquid and Peracid forte is 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 23 June 2020 to 25 June 2020 LABORATOIRE MIDAC RE20-0671-2 Page 3 sur 7 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 RE20-0671-2 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 : 96 104 100 Vc1 : Vc2 : NvB : 106 98 1.0x105 Vc1 : Vc2 : A : 96 94 95 Vc1 : Vc2 : B : 91 101 96 Vc1 : Vc2 : C : 92 108 100 Staphylococcus aureus DSM 799 Vc1 : Vc2 : Nv0 : 84 91 87.5 Vc1 : Vc2 : NvB : 84 78 8.1x104 Vc1 : Vc2 : A : 86 86 86 Vc1 : Vc2 : B : 89 82 85.5 Vc1 : Vc2 : C : 77 87 82 Enterococcus hirae DSM 3320 Vc1 : Vc2 : Nv0 : 62 58 60 Vc1 : Vc2 : NvB : 61 67 6.4x104 Vc1 : Vc2 : A : 60 67 63.5 Vc1 : Vc2 : B : 64 63 63.5 Vc1 : Vc2 : C : 63 59 61 Escherichia coli K12 DSM 11250 Vc1 : Vc2 : Nv0 : 77 74 75.5 Vc1 : Vc2 : NvB : 84 81 8.3x104 Vc1 : Vc2 : A : 72 70 71 Vc1 : Vc2 : B : 73 72 72.5 Vc1 : Vc2 : C : 76 79 77.5 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 RE20-0671-2 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 47 47 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 Staphylococcus aureus DSM 799 10-6 Vc1 : Vc2 : 10-7 Vc1 : Vc2 : N = N0 = log N0 = >330 >330 34 38 3.6x108 3.6x107 7.56 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 = 284 276 29 30 2.8x108 2.8x107 7.45 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 39 44 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 RE20-0671-2 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 : <3.15 log R : >5.52 log R : >5.52 Staphylococcus aureus DSM 799 log R : <3.04 log R : >5.41 log R : >5.41 Enterococcus hirae DSM 3320 log R : <2.93 log R : >5.30 log R : >5.30 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 RE20-0671-2 Page 7 sur 7 Number of repetitions : The test was carried out once. VI. CONCLUSION : According to the protocol of the NF EN 13727 : 2015 standard, the product Processus global de lavage à froid, Générateur à ozone avec adjonction de produits lessiviels dédiés (Lavage N°1: Textile de type laine) 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
