TEST REPORT N M STUDY NF EN 1040 April 2006 BACTERICIDAL ACTIVITY Obligatory and additional Conditions

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1 Test Report 09230M Study Accredited Test Laboratory N Details available at REPORT N 09230M This report replaces and cancels the precedent one ( ) Toulouse, October 6 th 2009 STUDY NF EN 1040 April 2006 ACTERICIDAL ACTIVITY Obligatory and additional Conditions Client CVE ZI de Pechnauquié VILLEMUR SUR TARN Assay Laboratory FONDEREPHAR Laboratoire de Microbiologie Industrielle 35 Chemin des Maraîchers TOULOUSE Cede 09 Report drafting Sylvie SALVATICO Technician Report Dr Christine ROQUES Assay Manager Report certifying Dr Jocelyne ACARIA Quality Manager This certificate may be not reproduced other than in full by photographic process. 1/11

2 I IDENTIFICATION OF ASSAY LAORATORY FONDEREPHAR Laboratoire de actériologie, Virologie et Microbiologie Industrielle Faculté des Sciences Pharmaceutiques 35 Chemin des Maraîchers Toulouse cede 9 II IDENTIFICATION OF PRODUCT Product LUETOO atch. F41 Date of receipt Internal code Active Substance. Not indicated Promotor. CVE Period of testing. June July 2009 Storage conditions. Room temperature III Dilution neutralization method. Tween 80 (10%), Lecithin (2%), Saponin (2%), Sodium thiosulfate (0.5%), trypcasesoja broth (atches 626, 627 and 631) Count per ml : 1 Product diluent. water for injectables preparations Appearance of the product. Liquid, clear FONDEREPHAR 2/11

3 IV EXPERIMENTAL CONDITIONS Product diluent. water for injectables preparations Obligatory Conditions Testorganism Pseudomonas aeruginosa CIP (ATCC 15442) Staphylococcus aureus CIP 4.83 (ATCC 6538) Concentrations of the product. 10%, 1% and 0,1% (V/V) Test temperature. 20 ± 1 C Contact time. ± 10 seconds Incubation temperature. 36 ± 1 C Additional Conditions Testorganism Escherichia coli CIP (ATCC 10536) Concentrations of the product. 10%, 1% and 0,1% (V/V) Test temperature. 20 ± 1 C Contact time. ± 10 seconds Testorganism Pseudomonas aeruginosa CIP (ATCC 15442) Staphylococcus aureus CIP 4.83 (ATCC 6538) Escherichia coli CIP (ATCC 10536) Concentrations of the product. 10% and 1% (V/V) Test temperature. 20 ± 1 C Contact time. ± 10 seconds Incubation temperature. 36 ± 1 C No precipitate during the test procedure (test mitures were homogeneous) The COFRAC Accreditation only attests the capability of the laboratory for tests NF EN 1040, NF EN 1275, NF EN 1276 and NF EN COFRAC is a signatory of the multilateral accord of EA (European cooperation for Acreditation) and of ILAC (International Laboratory Accreditation Cooperation), recognising the equivalence of test reports and analysis. FONDEREPHAR 3/11

4 V RESULTS STAPHYLOCOCCUS AUREUS : LUETOO atch F41 Assay 1 C Contact time 10% 1% Vc1Vc min min > Vc1 Vc min 106 mp = 319, min 107 lg N = 8,50 N 0 = 319, lg N 0 = 7,50 Na= < of 0,5 of C 0,5 of N Date of the test: Vc = Count per ml (one plate) wm = weighted mean of = average of Vc1 and Vc2 R = reduction (lgr = lgn 0 lgna) FONDEREPHAR 4/11

5 STAPHYLOCOCCUS AUREUS : LUETOO atch F41 Assay 2 C Contact time 10% 1% 0,1% Vc1Vc min min Vc1 Vc > 330 > min 85 mp = 274, min 87 lg N = 8,44 > 330 N 0 = 274, lg N 0 = 7,44 Na= 10 > < of 0,5 of C 0,5 of N > 3,52 < 3,92 Date of the test: Vc = Count per ml (one plate) wm = weighted mean of = average of Vc1 and Vc2 R = reduction (lgr = lgn 0 lgna) FONDEREPHAR 5/11

6 PSEUDOMONAS AERUGINOSA : LUETOO atch F41 Assay 1 C Contact time 10% 1% Vc1Vc min min 9392 > Vc1 Vc min 104 mp = 323, min 93 lg N = 8,51 N 0 = 323, lg N 0 = 7,51 Na= < of 0,5 of C 0,5 of N Date of the test: Vc = Count per ml (one plate) wm = weighted mean of = average of Vc1 and Vc2 R = reduction (lgr = lgn 0 lgna) FONDEREPHAR 6/11

7 PSEUDOMONAS AERUGINOSA: LUETOO atch F41 Assay 2 C Contact time 10% 1% 0,1% Vc1Vc min min Vc1 Vc > 330 > min 65 mp = 232, min 65 lg N = 8,37 21 > 330 N 0 = 232, lg N 0 = 7,37 Na= > < of 0,5 of C 0,5 of N 2,32 > 3,52 5,04 < 3,85 Date of the test: Vc = Count per ml (one plate) wm = weighted mean of = average of Vc1 and Vc2 R = reduction (lgr = lgn 0 lgna) FONDEREPHAR 7/11

8 ESCHERICHIA COLI : LUETOO atch F41 Assay 1 C Contact time 10% 1% Vc1Vc min min Vc1 Vc2 > 330 > min 60 mp = 229, min 85 lg N = 8,36 > N 0 = 229, lg N 0 = 7,36 Na= 10 > < of 0,5 of C 0,5 of N > 3,52 2,69 > 5,21 > 5,21 > 5,21 > 5,21 < 3,84 4,67 Date of the test: Vc = Count per ml (one plate) wm = weighted mean of = average of Vc1 and Vc2 R = reduction (lgr = lgn 0 lgna) FONDEREPHAR 8/11

9 ESCHERICHIA COLI : LUETOO atch F41 Assay 2 C Contact time 10% 1% Vc1Vc min min Vc1 Vc min 82 mp = 234, min 73 lg N = 8,37 N 0 = 234, lg N 0 = 7,37 Na= < of 0,5 of C 0,5 of N Date of the test: Vc = Count per ml (one plate) wm = weighted mean of = average of Vc1 and Vc2 R = reduction (lgr = lgn 0 lgna) FONDEREPHAR 9/11

10 ESCHERICHIA COLI : LUETOO atch F41 Assay 3 C Contact time 10% 1% 0,1% Vc1Vc min min Vc1 Vc2 > 330 > > 330 > min 69 mp = 206, min 63 lg N = 8,32 > 330 > 330 N 0 = 206, lg N 0 = 7,32 Na= 10 > < of 0,5 of C 0,5 of N > 3,52 < 3,80 > 5,17 < 3,80 Date of the test: Vc = Count per ml (one plate) wm = weighted mean of = average of Vc1 and Vc2 R = reduction (lgr = lgn 0 lgna) FONDEREPHAR 10/11

11 VI CONCLUSION For the product LUETOO batch F41, the basic bactericidal concentration determinated according to the NF EN 1040 standard (obligatory conditions: 5 min, 20 C) is 1% (V/V). In additional conditions the product LUETOO batch F41: has bactericidal activity on Escherichia coli CIP according to the NF EN 1040 standard (obligatory conditions: 5 min, 20 C) at the concentration of 1% (V/V). has bactericidal activity on Pseudomonas aeruginosa CIP , Staphylococcus aureus CIP 4.83 and Escherichia coli CIP , at 20 C, with 3 min contact time, at the concentration of 1% (V/V). FONDEREPHAR 11/11