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° RE20-0674-2 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 produit lessiviels dédiés (Lavage N°4: Textile de type couleur souillé) Batch : / On request of: GACHES CHIMIE SPECIALITES ACTIVITE ENTRETIEN TEXTILE 2 BIS CHEMIN DE LA SCIERIE FR 64800 OS MARSILLON Loos, 25 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 RE20-0674-2 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 produit lessiviels dédiés (Lavage N°4: Textile de type couleur souillé) 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 : / (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 others products are colorless liquid. Product diluent recommended by the manufacturer: Undiluted. LABORATOIRE MIDAC RE20-0674-2 Page 3 sur 7 III. TEST METHOD AND ITS VALIDATION : - Neutralization method : Dilution Neutralization. - Diluent neutralizer : Sodium thiosulphate neutralizer 14g/L. IV. EXPERIMENTAL CONDITIONS : Period of analysis: from 25 June 2020 to 27 June 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 RE20-0674-2 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 : 64 63 63.5 Vc1 : Vc2 : NvB : 61 54 5.8 ×104 Vc1 : Vc2 : A : 50 58 54 Vc1 : Vc2 : B : 41 39 40 Vc1 : Vc2 : C : 60 67 63.5 Staphylococcus aureus DSM 799 Vc1 : Vc2 : Nv0 : 59 79 69 Vc1 : Vc2 : NvB : 77 73 7.5×104 Vc1 : Vc2 : A : 46 63 54.5 Vc1 : Vc2 : B : 36 41 38.5 Vc1 : Vc2 : C : 93 98 95.5 Enterococcus hirae DSM 3320 Vc1 : Vc2 : Nv0 : 62 70 66 Vc1 : Vc2 : NvB : 57 57 5.7×104 Vc1 : Vc2 : A : 54 75 64.5 Vc1 : Vc2 : B : 58 64 61 Vc1 : Vc2 : C : 59 55 57 Escherichia coli K12 DSM 11250 Vc1 : Vc2 : Nv0 : 81 90 85.5 Vc1 : Vc2 : NvB : 66 71 6.9x104 Vc1 : Vc2 : A : 75 63 69 Vc1 : Vc2 : B : 47 54 50.5 Vc1 : Vc2 : C : 53 84 68.5 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 RE20-0674-2 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 = 168 187 14 24 1.8×108 1.8×107 7.26 10-0 Vc1 : Vc2 : 10-1 Vc1 : Vc2 : Na : log Na : 163 168 16 15 1.68×103 3.20 10-0 Vc1 : Vc2 : 10-1 Vc1 : Vc2 : Na : log Na : 0 0 0 0 <1.4×102 <2.15 10-0 Vc1 : Vc2 : 10-1 Vc1 : Vc2 : Na : log Na : 0 0 0 0 <1.4×102 <2.15 Staphylococcus aureus DSM 799 10-6 Vc1 : Vc2 : 10-7 Vc1 : Vc2 : N = N0 = log N0 = 291 279 19 20 2.8×108 2.8×107 7.45 10-0 Vc1 : Vc2 : 10-1 Vc1 : Vc2 : Na : log Na : >330 >330 >330 >330 >3.3×104 >4.52 10-0 Vc1 : Vc2 : 10-1 Vc1 : Vc2 : Na : log Na : 9 4 2 1 <1.4×102 <2.15 10-0 Vc1 : Vc2 : 10-1 Vc1 : Vc2 : Na : log Na : 0 0 0 0 <1.4×102 <2.15 Enterococcus hirae DSM 3320 10-6 Vc1 : Vc2 : 10-7 Vc1 : Vc2 : N = N0 = log N0 = 175 189 28 20 1.9×108 1.9×107 7.28 10-0 Vc1 : Vc2 : 10-1 Vc1 : Vc2 : Na : log Na : >330 >330 >330 >330 >3.3×104 >4.52 10-0 Vc1 : Vc2 : 10-1 Vc1 : Vc2 : Na : log Na : 0 0 0 0 <1.4×102 <2.15 10-0 Vc1 : Vc2 : 10-1 Vc1 : Vc2 : Na : log Na : 0 0 0 0 <1.4×102 <2.15 LABORATOIRE MIDAC RE20-0674-2 Page 6 sur 7 Escherichia coli K12 DSM 11250 10-6 Vc1 : Vc2 : 10-7 Vc1 : Vc2 : N = N0 = log N0 = 246 264 38 39 2.7×108 2.7×107 7.43 10-0 Vc1 : Vc2 : 10-1 Vc1 : Vc2 : Na : log Na : >330 >330 >330 >330 >3.3×104 >4.52 10-0 Vc1 : Vc2 : 10-1 Vc1 : Vc2 : Na : log Na : 0 0 0 0 <1.4×102 <2.15 10-0 Vc1 : Vc2 : 10-1 Vc1 : Vc2 : Na : log Na : 0 0 0 0 <1.4×102 <2.15 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 Reduction of the number of viable cells at the concentration tested (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 : 4.06 log R : >5.11 log R : >5.11 Staphylococcus aureus DSM 799 log R : <2.93 log R : >5.30 log R : >5.30 Enterococcus hirae DSM 3320 log R : <2.76 log R : >5.13 log R : >5.13 Escherichia coli K12 DSM 11250 log R : <2.91 log R : >5.28 log R : >5.28 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 RE20-0674-2 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 produit lessiviels dédiés (Lavage N°4: Textile de type couleur souillé) Batch : / possesses a bactericidal activity at tests 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
