t est certificate n¡ 1980 · id e n tifica tio n o f th e u se d m e th o d : e xp e rim e n ta l...
TRANSCRIPT
Product :
Contact :
Test certificate N° 1980
Customer identity
Name : HYPRED SA
Address :
Surname : First name
Tel:
Tel : Fax : E-mail :
Fax : E-mail:
55 bd Jules Verger
35803 Dinard Cedex
DEMOMENT Isabelle
0299165035 0299165275 [email protected]
1155Codification :
Batch number : 07/08/03/10
Print date : 15/11/10
Bactericidal
55 Bd Jules Verger - 35 803 DINARD Cedex Tél : +33 (0)2 99 16 50 72 - Fax : +33 (0)2 99 16 52 75
LABORATOIRE DE
MICROBIOLOGIE
ET D’HYGIENELMH
1/4
Address :
HYPRED SAAddress :
PODOCUR SV
-1
to the norm : NF EN 1656 (March 2010)
First print date : 02/11/10
efficiency test according
FM064J
Test certificate N° 1980
Sample identification
1155Name of the product :
Batch : 07/08/03/10
Active principle:
Print date : 15/11/10
Receipt date :
Date of manufacture :
13/09/10
08/07/10
Appearance : clear blue product
LABORATOIRE DE
MICROBIOLOGIE
ET D’HYGIENELMH
2/4
PODOCUR SV
-1First print date : 02/11/10
55 Bd Jules Verger - 35 803 DINARD Cedex Tél : +33 (0)2 99 16 50 72 - Fax : +33 (0)2 99 16 52 75
FM064J
Expiration date :08/07/11
Sample identification
Not filled
Identification of the used method :
Sample identification
Diluent of the product recommended by the manufacturer : Tap water
Strain(s)
165Method : NF EN 1656 (Mars 2010)
Membrane filtrationTest method :
rinsing out liquid
Enterococcus hirae CIP 58.55-Col:CIP 58.55Staphylococcus aureus CIP 4.83-Col:CIP 4.83Proteus vulgaris CIP 58.60-Col:CIP 58.60Pseudomonas aeruginosa DSM 939-Col:939
distilled waterdistilled waterdistilled waterdistilled water
Identification of the used method : Identification of the used method :
Experimental conditions :
2,5 5 8 10 15
10
15Contact time :
Test temperature :
Tested concentrations of the product :
10g/l bovine albumin + 10g/l yeast extract
(min)
(°C)
%
145Interfering substance :
Diluent described in the norm : Hard water
20/10/10Start of analysis :
End of analysis : 02/11/10
37Incubation temperature : (°C)
Stability of the mixture of interfering substance and diluted product : No precipitate during assay
A-F. GABILLETTest manager :
(V/V)
2,5 5 8 10 15
-
198015/11/10
3/4
55 Bd Jules Verger - 35 803 DINARD Cedex Tél : 02 99 16 50 72 - Fax : 02 99 16 52 75
LABORATOIRE DE
MICROBIOLOGIE
ET D’HYGIENELMH-1
02/11/10
Validation testOperating method at the concentration %
Tested strain(s) Bactericidal or Fungicidal tested
suspension Experimental conditions
Non toxicity of the neutraliser
or reference filtration
Inactivation by dilution/
neutralisation or filtration
Bactericidal or Fungicidal suspension
Test certificate N°
Results
Print date :
First print date :
FM064J
Non toxicité du neutralisant ou témoin
de filtration
Vc : Vc : Vc : Vc : Vc :
610 710- -
89;74 61;75 63;48 65;68 Vc :
A: B: C:68 56 67
>165;>165 0;0 0;0 0;0 0;0>165;>165 32;47
408
Enterococcus hirae CIP 58.55-Col:CIP 58.55 N 10
N0 10
8
7Nv: 815
Nv0: 82 Q : Non calculable
3,95
3,95Na : >1650 <140 <140 <140 <140
R(lg)) : R<5 R>5 R>5 R>5 R>5
Non toxicité du neutralisant ou témoin
de filtration
Vc : Vc : Vc : Vc : Vc :
610 710- -
79;72 61;63 61;54 57;69 Vc :
A: B: C:62 58 63
0;0 1;0 0;0 0;0 0;0>165;>165 44;45
406
Staphylococcus aureus CIP 4.83-Col:CIP 4.83 N 10
N0 10
8
7Nv: 755
Nv0: 76 Q : Non calculable
4,45
4,45Na : <140 <140 <140 <140 <140
R(lg)) : R>5 R>5 R>5 R>5 R>5
Non toxicité du neutralisant ou témoin
de filtration
Vc : Vc : Vc : Vc : Vc :
610 710- -
83;128 110;101 102;83 98;81 Vc :
A: B: C:106 93 90
4;3 0;0 0;0 0;0 0;0>165;>165 49;59
409
Proteus vulgaris CIP 58.60 - CIP 58.60 N 10
N0 10
8
7Nv: 1055
Nv0: 106 Q : Non calculable
5,40
5,40Na : <140 <140 <140 <140 <140
R(lg)) : R>5 R>5 R>5 R>5 R>5
Non toxicité du neutralisant ou témoin
de filtration
Vc : Vc : Vc : Vc : Vc :
610 710- -
80;75 124;116 121;146 165;130 Vc :
A: B: C:120 134 148
>165;>165 >165;>165 6;23 0;0 0;0>165;>165 32;29
402
Pseudomonas aeruginosa DSM 939 - 939 N 10
N0 10
8
7Nv: 775
Nv0: 78 Q : Non calculable
3,05
3,05Na : >1650 >1650 < 185 <140 <140
R(lg)) : R<5 R<5 > 5,22 R>5 R>5
Vc : number of colony-forming unit(s) per plate N : number of cells per ml in the test suspension Nv : number of cells per ml in the validation suspension Na : number of survivors per ml in the test mixture R : logarithm reduction A : number of survivors in the experimental conditions B : number of survivors in the neutralizer control or filtration control C : number of survivors in the dilution-neutralization or the membrane filtration method validation
Test validated for: N between 1,5-5.10^8 (log : 8,17-8,70) N0 between 1,5-5.10^7 (log : 7,17-7,70) Nv0 between 30 and 160 A, B and C equal to or greater than 0.5Nv0 Q between 5 and 15
Test certificate N°
15/11/10
Conclusion :
According to the norm NF EN 1656 (March 2010), 07/08/03/10 batch of PODOCUR SV product of HYPRED SA firm, when diluted to 8% (V/V) in presence of bovine albumin (10 g/l) and yeast extract (10 g/l), presents a bactericidal activity, for 15 minutes contact time, at 10°C , towards the strain(s) : Enterococcus hirae CIP 58.55, Staphylococcus aureus CIP 4.83, Proteus vulgaris CIP 58.60, Pseudomonas aeruginosa DSM 939. Strains are preserved and checked according to EN 12353. Comments :
Written by:
on :
Signature :
Approved by:
on :
Signature :
LABORATOIRE DE
MICROBIOLOGIE
ET D’HYGIENELMH
4/4
1980-1
15/11/10 15/11/10
02/11/10
Print date :
First print date : 55 Bd Jules Verger - 35 803 DINARD Cedex
Tél : +33 (0)2 99 16 50 72 - Fax : +33 (0)2 99 16 52 75
A-F. GABILLET M. SESQUES
Testing officer Technical director
FM064J
Product :
Contact :
Customer identity
Name : HYPRED SA
Address :
Surname : First name
Tel:
Tel : Fax : E-mail :
Fax : E-mail:
55 bd Jules Verger
35803 Dinard Cedex
DEMOMENT Isabelle
0299165035 0299165275 [email protected]
1155Codification :
Batch number : 07/08/03/10
Print date : 09/12/1055 Bd Jules Verger - 35 803 DINARD Cedex
Tél : +33 (0)2 99 16 50 72 - Fax : +33 (0)2 99 16 52 75
LABORATOIRE DE
MICROBIOLOGIE
ET D’HYGIENELMH
1/7
Address :
HYPRED SAAddress :
PODOCUR SV
First print date : 09/12/10
FM064K
Test certificate N° 1954 -1
Bactericidal efficiency test
according to the methodology of the norme NF EN 14349 (April 2008)
This test certificate concerns only the tested product . Duplication of this test certificate is only authorised in it's entirely This test certificate is composed of 7 pages (this page included)
Test certificate N° 1954
Sample identification
1155Name of the product :
Batch : 07/08/03/10
Active principle:
Print date : 09/12/10
Receipt date :
Date of manufacture :
13/09/10
08/07/10
Appearance : clear blue product
LABORATOIRE DE
MICROBIOLOGIE
ET D’HYGIENELMH
2/7
PODOCUR SV
-1First print date : 09/12/10
55 Bd Jules Verger - 35 803 DINARD Cedex Tél : +33 (0)2 99 16 50 72 - Fax : +33 (0)2 99 16 52 75
FM064K
Expiration date :08/07/11
Sample identification
Not filled
Identification of the used method :
Sample identification
Diluent of the product recommended by the manufacturer : Tap water
Strain(s)
156Method : NF EN 14349 (Avril 2008)
Appearance :
Neutralizing agent
Enterococcus hirae CIP 58.55-Col:CIP 58.55Staphylococcus aureus CIP 4.83-Col:CIP 4.83Proteus vulgaris CIP 58.60-Col:CIP 58.60Pseudomonas aeruginosa DSM 939-Col:939
B neutralizerB neutralizerB neutralizerB neutralizer
Identification of the used method :
B neutralizer : (3 %) Polysorbate 80 (ml); (3 %) Saponine (g); (0,3 %) Lecithin (g); (0,1 %) L-Histidin (g); (0,5 %) Sodium thiosulphate (g)
Identification of the used method :
Experimental conditions :
5 8 10 15
10
15Contact time :
Test temperature :
Tested concentrations of the product :
10g/l bovine albumin + 10g/l yeast extract
(min)
(°C)
%
145Interfering substance :
Diluent described in the norm : Hard water
18/11/10Start of analysis :
End of analysis : 09/12/10
37Incubation temperature : (°C)
Stability of the mixture of interfering substance and diluted product : not concerned
A-F. GABILLETTest manager :
(V/V)
5 8 10 15
Water control Dilution-neutralization control
Neutralizer toxicity control
Bactericidal or Fungicidal tested
suspension
Validation testTested strain(s)Operating method at the concentration %
LABORATOIRE DE
MICROBIOLOGIE
ET D’HYGIENELMHTest certificat N° 1954
Results
-1
09/12/10
3/7
09/12/10
Print date :
First print date : 55 Bd Jules Verger - 35 803 DINARD Cedex
Tél : +33 (0)2 99 16 50 72 - Fax : +33 (0)2 99 16 52 75
FM064K
10 10 10 101010
Vc : Vc : Vc :>300;>300 >300;>300 >300;>300
n: 0 2 2n: n: n:0 0 0 2
Vc : >300;>300 0;0 0;0 0;0
408
Enterococcus hirae CIP 58.55-Col:CIP 58.55
-
3
10- 3
10- 3
10- 0
10- 0
10- 0
10- 0
10- 0
10-
dil : dil : dil : dil :
10 10 10 101010
Vc : Vc : Vc :>300;>300 >300;>300 >300;>300
n: 0 0 0n: n: n:0 0 0 0
Vc : >300;>300 0;0 0;0 0;0
408
Enterococcus hirae CIP 58.55-Col:CIP 58.55
-
4
10- 4
10- 4
10- 1
10- 1
10- 1
10- 1
10- 1
10-
dil : dil : dil : dil :
10 10 10 101010
Vc : Vc : Vc :20;26 35;34 36;38
n: 0 0 0n: n: n:2 2 2 0
Vc : >300;>300 0;0 0;0 0;0
408
Enterococcus hirae CIP 58.55-Col:CIP 58.55
-
5
10- 5
10- 5
10- 2
10- 2
10- 2
10- 2
10- 2
10-
dil : dil : dil : dil :
10 10 10 1010d10 10 10
Nc: 7,50 7,607,40
R<4 R>4 R>4 R>4
n: 2 1
N: 7,70
Nd: >5,5 < 2,2 < 2,2 < 2,2
Vc : 192;183 10;16
408
Enterococcus hirae CIP 58.55-Col:CIP 58.55
710
8- -10
Nts: 5
Nts: >100 0 0 0
B: A:
R:
N: log number of cfu per 0.05ml of test suspension ; Nc: log number of cfu/ml per control surface ; Nd: log number of cfu/ml per test surface ; A: log number of cfu/ml per test surface of the neutralizer toxicity control ; B: log number of cfu/ml of the dilution-neutralization control Nts: growth observed on treated surface R: reduction in viability
Methodology checked for : * N is between 7.6 and 8.1 ; * N-Nc is not greater than 3 log10 ; * N-A is not greater than 3 log10 ; * A-B is not greater than à ± 0.3 log10.
5 8 10 15
Water control Dilution-neutralization control
Neutralizer toxicity control
Bactericidal or Fungicidal tested
suspension
Validation testTested strain(s)Operating method at the concentration %
LABORATOIRE DE
MICROBIOLOGIE
ET D’HYGIENELMHTest certificat N° 1954
Results
-1
09/12/10
4/7
09/12/10
Print date :
First print date : 55 Bd Jules Verger - 35 803 DINARD Cedex
Tél : +33 (0)2 99 16 50 72 - Fax : +33 (0)2 99 16 52 75
FM064K
10 10 10 101010
Vc : Vc : Vc :>300;>300 >300;>300 >300;>300
n: 0 2 2n: n: n:0 0 0 2
Vc : >300;>300 0;0 0;0 0;0
406
Staphylococcus aureus CIP 4.83-Col:CIP 4.83
-
3
10- 3
10- 3
10- 0
10- 0
10- 0
10- 0
10- 0
10-
dil : dil : dil : dil :
10 10 10 101010
Vc : Vc : Vc :>300;>300 >300;>300 >300;>300
n: 0 0 0n: n: n:0 0 0 0
Vc : >300;>300 0;0 0;0 0;0
406
Staphylococcus aureus CIP 4.83-Col:CIP 4.83
-
4
10- 4
10- 4
10- 1
10- 1
10- 1
10- 1
10- 1
10-
dil : dil : dil : dil :
10 10 10 101010
Vc : Vc : Vc :26;41 23;39 18;19
n: 0 0 0n: n: n:2 2 2 0
Vc : >300;>300 0;0 0;0 0;0
406
Staphylococcus aureus CIP 4.83-Col:CIP 4.83
-
5
10- 5
10- 5
10- 2
10- 2
10- 2
10- 2
10- 2
10-
dil : dil : dil : dil :
10 10 10 1010d10 10 10
Nc: 7,50 7,307,50
R<4 R>4 R>4 R>4
n: 2 1
N: 7,60
Nd: >5,5 < 2,2 < 2,2 < 2,2
Vc : 163;156 19;13
406
Staphylococcus aureus CIP 4.83-Col:CIP 4.83
710
8- -10
Nts: >100
Nts: >100 0 0 0
B: A:
R:
N: log number of cfu per 0.05ml of test suspension ; Nc: log number of cfu/ml per control surface ; Nd: log number of cfu/ml per test surface ; A: log number of cfu/ml per test surface of the neutralizer toxicity control ; B: log number of cfu/ml of the dilution-neutralization control Nts: growth observed on treated surface R: reduction in viability
Methodology checked for : * N is between 7.6 and 8.1 ; * N-Nc is not greater than 3 log10 ; * N-A is not greater than 3 log10 ; * A-B is not greater than à ± 0.3 log10.
5 8 10 15
Water control Dilution-neutralization control
Neutralizer toxicity control
Bactericidal or Fungicidal tested
suspension
Validation testTested strain(s)Operating method at the concentration %
LABORATOIRE DE
MICROBIOLOGIE
ET D’HYGIENELMHTest certificat N° 1954
Results
-1
09/12/10
5/7
09/12/10
Print date :
First print date : 55 Bd Jules Verger - 35 803 DINARD Cedex
Tél : +33 (0)2 99 16 50 72 - Fax : +33 (0)2 99 16 52 75
FM064K
10 10 10 101010
Vc : Vc : Vc :>300;>300 >300;>300 >300;>300
n: 2 2 2n: n: n:0 0 0 2
Vc : 0;0 6;8 0;0 0;0
409
Proteus vulgaris CIP 58.60-Col:CIP 58.60
-
3
10- 3
10- 3
10- 0
10- 0
10- 0
10- 0
10- 0
10-
dil : dil : dil : dil :
10 10 10 101010
Vc : Vc : Vc :74;78 74;68 94;97
n: 0 0 0n: n: n:2 2 2 0
Vc : 0;0 1;1 0;0 0;0
409
Proteus vulgaris CIP 58.60-Col:CIP 58.60
-
4
10- 4
10- 4
10- 1
10- 1
10- 1
10- 1
10- 1
10-
dil : dil : dil : dil :
10 10 10 101010
Vc : Vc : Vc :8;5 8;10 8;10
n: 0 0 0n: n: n:0 0 0 0
Vc : 0;0 0;0 0;0 0;0
409
Proteus vulgaris CIP 58.60-Col:CIP 58.60
-
5
10- 5
10- 5
10- 2
10- 2
10- 2
10- 2
10- 2
10-
dil : dil : dil : dil :
10 10 10 1010d10 10 10
Nc: 6,90 7,006,90
R>4 R>4 R>4 R>4
n: 2 2
N: 7,60
Nd: < 2,2 < 2,2 < 2,2 < 2,2
Vc : 191;163 15;18
409
Proteus vulgaris CIP 58.60-Col:CIP 58.60
710
8- -10
Nts: 46
Nts: 0 0 0 0
B: A:
R:
N: log number of cfu per 0.05ml of test suspension ; Nc: log number of cfu/ml per control surface ; Nd: log number of cfu/ml per test surface ; A: log number of cfu/ml per test surface of the neutralizer toxicity control ; B: log number of cfu/ml of the dilution-neutralization control Nts: growth observed on treated surface R: reduction in viability
Methodology checked for : * N is between 7.6 and 8.1 ; * N-Nc is not greater than 3 log10 ; * N-A is not greater than 3 log10 ; * A-B is not greater than à ± 0.3 log10.
5 8 10 15
Water control Dilution-neutralization control
Neutralizer toxicity control
Bactericidal or Fungicidal tested
suspension
Validation testTested strain(s)Operating method at the concentration %
LABORATOIRE DE
MICROBIOLOGIE
ET D’HYGIENELMHTest certificat N° 1954
Results
-1
09/12/10
6/7
09/12/10
Print date :
First print date : 55 Bd Jules Verger - 35 803 DINARD Cedex
Tél : +33 (0)2 99 16 50 72 - Fax : +33 (0)2 99 16 52 75
FM064K
10 10 10 101010
Vc : Vc : Vc :>300;>300 >300;>300 >300;>300
n: 0 2 2n: n: n:0 0 0 2
Vc : >300;>300 0;0 0;0 0;0
402
Pseudomonas aeruginosa DSM 939-Col:939
-
3
10- 3
10- 3
10- 0
10- 0
10- 0
10- 0
10- 0
10-
dil : dil : dil : dil :
10 10 10 101010
Vc : Vc : Vc :>300;>300 >300;>300 >300;>300
n: 0 0 0n: n: n:0 0 0 0
Vc : >300;>300 0;0 0;0 0;0
402
Pseudomonas aeruginosa DSM 939-Col:939
-
4
10- 4
10- 4
10- 1
10- 1
10- 1
10- 1
10- 1
10-
dil : dil : dil : dil :
10 10 10 101010
Vc : Vc : Vc :43;48 31;43 63;59
n: 2 0 0n: n: n:2 2 2 0
Vc : 28;26 0;0 0;0 0;0
402
Pseudomonas aeruginosa DSM 939-Col:939
-
5
10- 5
10- 5
10- 2
10- 2
10- 2
10- 2
10- 2
10-
dil : dil : dil : dil :
10 10 10 1010d10 10 10
Nc: 7,60 7,807,70
3,3 R>4 R>4 R>4
n: 0 2
N: 8,00
Nd: 4,4 < 2,2 < 2,2 < 2,2
Vc : >300;>300 41;32
402
Pseudomonas aeruginosa DSM 939-Col:939
710
8- -10
Nts: >100
Nts: 0 0 0 0
B: A:
R:
N: log number of cfu per 0.05ml of test suspension ; Nc: log number of cfu/ml per control surface ; Nd: log number of cfu/ml per test surface ; A: log number of cfu/ml per test surface of the neutralizer toxicity control ; B: log number of cfu/ml of the dilution-neutralization control Nts: growth observed on treated surface R: reduction in viability
Methodology checked for : * N is between 7.6 and 8.1 ; * N-Nc is not greater than 3 log10 ; * N-A is not greater than 3 log10 ; * A-B is not greater than à ± 0.3 log10.
Test certificate N°
09/12/10
Conclusion :
According to the norm NF EN 14349 (April 2008), 07/08/03/10 batch of PODOCUR SV product of HYPRED SA firm, when diluted to 8% (V/V) in presence of 10g/l bovine albumin and 10g/l yeast extract, presents a bactericidal activity, for 15 minutes contact time, at 10°C , towards the strain(s) : Enterococcus hirae CIP 58.55, Staphylococcus aureus CIP 4.83, Proteus vulgaris CIP 58.60, Pseudomonas aeruginosa DSM 939. Strains are preserved and checked according to EN 12353. Comments :
Written by:
on :
Signature :
Approved by:
on :
Signature :
LABORATOIRE DE
MICROBIOLOGIE
ET D’HYGIENELMH
7/7
1954-1
09/12/10 09/12/10
09/12/10
Print date :
First print date : 55 Bd Jules Verger - 35 803 DINARD Cedex
Tél : +33 (0)2 99 16 50 72 - Fax : +33 (0)2 99 16 52 75
A-F. GABILLET M. SESQUES
Testing officer Technical director
FM064K
Product :
Contact :
Test certificate N° 2004
Customer identity
Name : HYPRED SA
Address :
Surname : First name
Tel:
Tel : Fax : E-mail :
Fax : E-mail:
55 bd Jules Verger
35803 Dinard Cedex
DEMOMENT Isabelle
0299165035 0299165275 [email protected]
1155Codification :
Batch number : 07/08/03/10
Print date : 25/11/10
Yeasticidal
55 Bd Jules Verger - 35 803 DINARD Cedex Tél : +33 (0)2 99 16 50 72 - Fax : +33 (0)2 99 16 52 75
LABORATOIRE DE
MICROBIOLOGIE
ET D’HYGIENELMH
1/4
Address :
HYPRED SAAddress :
PODOCUR SV
-1
to the norm : NF EN 1657 (April 2006)
First print date : 19/11/10
efficiency test according
FM064J
Test certificate N° 2004
Sample identification
1155Name of the product :
Batch : 07/08/03/10
Active principle:
Print date : 25/11/10
Receipt date :
Date of manufacture :
13/09/10
08/07/10
Appearance : clear blue product
LABORATOIRE DE
MICROBIOLOGIE
ET D’HYGIENELMH
2/4
PODOCUR SV
-1First print date : 19/11/10
55 Bd Jules Verger - 35 803 DINARD Cedex Tél : +33 (0)2 99 16 50 72 - Fax : +33 (0)2 99 16 52 75
FM064J
Expiration date :08/07/11
Sample identification
Not filled
Identification of the used method :
Sample identification
Diluent of the product recommended by the manufacturer : Tap water
Strain(s)
150Method : NF EN 1657 (Avril 2006)
Membrane filtrationTest method :
rinsing out liquid
Candida albicans DSM 1386-Col:1386 distilled water
Identification of the used method : Identification of the used method :
Experimental conditions :
1 5 8 10
10
15Contact time :
Test temperature :
Tested concentrations of the product :
10g/l bovine albumin + 10g/l yeast extract
(min)
(°C)
%
145Interfering substance :
Diluent described in the norm : Hard water
17/11/10Start of analysis :
End of analysis : 19/11/10
30Incubation temperature : (°C)
Stability of the mixture of interfering substance and diluted product : No precipitate during assay
A-F. GABILLETTest manager :
(V/V)
1 5 8 10
-
200425/11/10
3/4
55 Bd Jules Verger - 35 803 DINARD Cedex Tél : 02 99 16 50 72 - Fax : 02 99 16 52 75
LABORATOIRE DE
MICROBIOLOGIE
ET D’HYGIENELMH-1
19/11/10
Validation testOperating method at the concentration %
Tested strain(s) Bactericidal or Fungicidal tested
suspension Experimental conditions
Non toxicity of the neutraliser
or reference filtration
Inactivation by dilution/
neutralisation or filtration
Bactericidal or Fungicidal suspension
Test certificate N°
Results
Print date :
First print date :
FM064J
Non toxicité du neutralisant ou témoin
de filtration
Vc : Vc : Vc : Vc : Vc :
510 610- -
43;42 49;58 47;48 55;46 Vc :
A: B: C:54 48 51
>165;>165 4;17 0;0 0;0>165;>165 26;26
403
Candida albicans DSM 1386-Col:1386 N 10
N0 10
7
6Nv: 425
Nv0: 43 Q : Non calculable
2,60
2,60Na : >1650 < 155 <140 <140
R(lg)) : R<4 > 4,22 R>4 R>4
Vc : number of colony-forming unit(s) per plate N : number of cells per ml in the test suspension Nv : number of cells per ml in the validation suspension Na : number of survivors per ml in the test mixture R : logarithm reduction A : number of survivors in the experimental conditions B : number of survivors in the neutralizer control or filtration control C : number of survivors in the dilution-neutralization or the membrane filtration method validation
A test is validated for : N between 1.5 - 5 10^7 (lg: 7.17 - 7.70) N0 between 1,5 - 5.10^6 (lg: 6.17 - 6.70) Nv0 between 30 and 160 A, B and C equal to or greater than 0.5Nv0 Q between 5 et 15
Test certificate N°
25/11/10
Conclusion :
According to the norm NF EN 1657 (April 2006), 07/08/03/10 batch of PODOCUR SV product of HYPRED SA firm, when diluted to 5% (V/V) in presence of bovine albumin (10g/l ) and yeast extract (10g/l ), presents a yeasticidal activity, for 15 minutes contact time, at 10°C , towards the strain(s) : Candida albicans DSM 1386. Strains are preserved and checked according to EN 12353. Comments :
Written by:
on :
Signature :
Approved by:
on :
Signature :
LABORATOIRE DE
MICROBIOLOGIE
ET D’HYGIENELMH
4/4
2004-1
25/11/10 25/11/10
19/11/10
Print date :
First print date : 55 Bd Jules Verger - 35 803 DINARD Cedex
Tél : +33 (0)2 99 16 50 72 - Fax : +33 (0)2 99 16 52 75
A-F. GABILLET M. SESQUES
Testing officer Technical director
FM064J
FM 064 F
TEST CERTIFICATE N°1957-1
55 Boulevard Jules Verger 35803 DINARD Cedex
Tél. 02 99 16 50 72
Fax. 02 99 16 52 75 First print date: 10/12/10
Print date: 10/12/10
1/4
LABORATOIRE DE MICROBIOLOGIE
ET D’HYGIENE L M H
Yeasticidal efficiency test according to the norm NF EN 14349 (April 2008)
PODOCUR SV
I- CUSTOMER IDENTITY
Isabelle DEMOMENT
HYPRED SA
55 Bd Jules Verger
35 803 DINARD Cedex
FRANCE
Tél. 00-33- 2-99-16-50-35 - Fax. 00-33-2-99-16-50-00
II- PRODUCT
- Product name: PODOCUR SV
- Batch number:07/08/03/10
- Manufacture date: 08/07/2010
- Expiry date: 08/07/2011
- Receipt date : 13/09/10
- Appearence: Limpid product
- Storage conditions: room temperature
- Diluent of the product recommended by the manufacturer: tap water
III- EXPERIMENTAL CONDITIONS
Method: According to the methodology of the norm NF EN 14349 (April 2008), dilution -
neutralization
B Neutralizer
3% Polysorbate 80 (m/V),
3% Saponine (m/V), 0,3% Lécithin(m/V),
0,1% L-Histidin (m/V),
0,5% Sodium Thiosulfate
FM 064 F
TEST CERTIFICATE N°1957-1
55 Boulevard Jules Verger 35803 DINARD Cedex
Tél. 02 99 16 50 72
Fax. 02 99 16 52 75 First print date: 10/12/10
Print date: 10/12/10
2/4
LABORATOIRE DE MICROBIOLOGIE
ET D’HYGIENE L M H
- Start of analysis: 08/12/10
- End of analysis : 10/12/10
- Test method : dilution - neutralization
- Test manager: AF. GABILLET
- Diluent described in the norm: Hard water 30°f
- Tested dilutions (V/V) : 5%-8%-10%-15%
- Stability of the mixture of interfering substance and diluted product : not concerned
- Contact time: 15 minutes +/- 10 seconds
- Test temperature: between :10°C (+/-1°C)
- Interfering substance :Bovine albumin 10g/l and yeast extract 10 g/l
- Incubation temperature : 30°C +/- 1°C
- Using strains :
Candida albicans DSM 1386
III- RESULTS
N: Test suspension, A : Log number of CFU/ml per test surface of the neutralizer toxicity control,
B : Log number of CFU/ml per test surface of the dilution-neutralization control,,
Nc : Log number of CFU/ml per water control surface,, Nd : Log number of CFU/ml per test surface,
Nts : Growth observed on treated surface
ME : Microbicidal effest
FM 064 F
TEST CERTIFICATE N°1957-1
55 Boulevard Jules Verger 35803 DINARD Cedex
Tél. 02 99 16 50 72
Fax. 02 99 16 52 75 First print date: 10/12/10
Print date: 10/12/10
3/4
LABORATOIRE DE MICROBIOLOGIE
ET D’HYGIENE L M H
Tested
suspension
Neutralizer
toxicity
control
Dilution/neu
tralization
control
Water
control Tested dilutions % (V/V)
Teste
d
str
ain
s
N A B Nc 5% 8% 10% 15%
Ca
nd
ida a
lbic
an
s
DS
M 1
38
6 (10-5)
>300 ;>300 (10-6)
24 ;33
N = 5,85
(10-2)
125 ;107 (10-3)
12 ;12
(10-5) 2 ;2
A = 5,06
(10-2)
148 ;102 (103)
14 ;25
(104) 1 ;1
B = 5,09
(10-2)
>300 ; >300 (10-3)
30 ;27
(10-4) 3 ;5
Nc = 5,45
Nts = 4
(100)
>300 ;>300 (10-1)
>300 ;>300
(10-2) >300 ;>300
Nd>5,48 Nts >100
ME<3
(100)
0 ;0 (10-1)
0 ;0
(10-2) 0 ;0
Nd < 2,2 Nts =0
ME >3
(100)
0 ;0 (10-1)
0 ;0
(10-2) 0 ;0
Nd<2,2 Nts =0
ME >3
(100)
0 ;0 (10-1)
0 ;0
(10-2) 0 ;0
Nd<2,2 Nts =0
ME>3
FM 064 F
TEST CERTIFICATE N°1957-1
55 Boulevard Jules Verger 35803 DINARD Cedex
Tél. 02 99 16 50 72
Fax. 02 99 16 52 75 First print date: 10/12/10
Print date: 10/12/10
4/4
LABORATOIRE DE MICROBIOLOGIE
ET D’HYGIENE L M H
IV- CONCLUSION
According to the methodology of the norm NF EN 14349(April 2008), 07/08/03/10 batch of
PODOCUR SV product of HYPRED SA, when diluted to 8% (V/V) in presence of bovin
albumin 10 g/l and yeast extract 10 g/l, presents a yeasticidal activity on non porous surfaces
for 15 minutes contact time, at 10°C, towards the strain Candida albicans DSM 1386
Strains are preserved and checked according to the norm NF EN 12353.
VI- SIGNATURES
Written by Approved by
AF. GABILLET
M. SESQUES
Technical director