Test certificate N° 1872 -1

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MH
L
LABORATOIRE DE
MICROBIOLOGIE
ET D’HYGIENE
FM064J
First print date :28/05/10
55 Bd Jules Verger - 35 803 DINARD Cedex
Tél : +33 (0)2 99 16 50 72 - Fax : +33 (0)2 99 16 52 75
Print date :23/06/10
1/4
Test certificate N° 1872 -1
Bactericidal efficiency test according
to the norm : NF EN 1656 (March 2010)
Address :
Address : HYPRED
SA
Customer identity
Name : HYPRED SA
Address : 55 bd Jules Verger
35803
Tel :
Dinard Cedex
Fax :
E-mail : idemoment@roullier.com
Contact :
Surname : DEMOMENT
Tel: 0299165035
First name Isabelle
Fax : 0299165275
E-mail: idemoment@roullier.com
Product :
Codification :
1118
IODERM PSP
Batch number : 04/26/02/10
Accreditation :
Accreditation
N° 1-1308
Accreditation of COFRAC laboratory section proves competence of laboratories only for test
covered by accreditation. If particular notifications have been made in the method of indicated , these
modifications or specifications are listed in the part "Comment" at the end of the test certificate.
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 4 pages (this page included)
MH
L
FM064J
LABORATOIRE DE
MICROBIOLOGIE
ET D’HYGIENE
55 Bd Jules Verger - 35 803 DINARD Cedex
Tél : +33 (0)2 99 16 50 72 - Fax : +33 (0)2 99 16 52 75
Test certificate N° 1872 -1
First print date :28/05/10
Print date :23/06/10
2/4
Sample
Sample identification
identification
Name of the product :
IODERM PSP
1118
Batch : 04/26/02/10
Appearance : thick brown product
Receipt date : 12/05/10
Date of manufacture : 26/04/10
Expiration date :26/04/11
Active principle:
Not filled
Diluent of the product recommended by the manufacturer : Tap water
Identification
Identification of
of the
the used
used method
method ::
Method : 165
NF EN 1656 (Mars 2010)
Test method : Dilution / neutralization
Strain(s)
Neutralizing agent
Staphylococcus aureus CIP 4.83-Col:CIP 4.83
Escherichia coli CIP 54.127-Col:CIP 54.127
Streptococcus uberis CIP 103219-Col: 103219
B neutralizer
B neutralizer
B neutralizer
Appearance :
B neutralizer : (3 %) Polysorbate 80 (ml); (3 %) Saponine (g); (0,3 %) Lecithin (g); (0,1 %) L-Histidin (g); (0,5 %) Sodium thiosulphate (g)
Experimental conditions :
Test manager :A-F. GABILLET
Start of analysis :
26/05/10
End of analysis :
28/05/10
Tested concentrations of the product : 0,1
50
80
Interfering substance :
Contact time :
Test temperature :
Incubation temperature :
%
(V/V)
164 skimmed milk 1%
5 (min)
30 (°C)
37 (°C)
Diluent described in the norm : Distilled water
Stability of the mixture of interfering substance and diluted product : No precipitate during assay
MH
L
LABORATOIRE DE
MICROBIOLOGIE
ET D’HYGIENE
Test certificate N° 1872 -1
55 Bd Jules Verger - 35 803 DINARD Cedex
Tél : 02 99 16 50 72 - Fax : 02 99 16 52 75
First print date : 28/05/10
Print date : 23/06/10
3/4
Results
Tested strain(s)
Validation test
Bactericidal or
Fungicidal
suspension
Experimental
conditions
Non
toxicité du
Non toxicity of
neutralisant
ou témoin
the neutraliser
de filtration
or reference
filtration
Vc :
131;104
Nv:
1175
Nv0:
118
Vc :
82;82
Vc :
A:
166;119
143
Vc :
134;125
Non toxicité du
130
B:
neutralisant
ou témoin
de filtration
Vc :
Vc :
82;73
Non toxicité du
78 témoin
B:
neutralisant
ou
de filtration
Vc :
C:
115;111
113
407
Escherichia coli CIP 54.127Col:CIP 54.127
Nv:
820
Nv0:
82
Vc :
83;106
Vc :
A:
80;87
84
C:
70;77
74
428
Streptococcus uberis CIP
103219-Col: 103219
Nv:
945
Nv0:
95
Vc :
A:
103;104
104
Vc :
B:
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
100;101
101
Bactericidal or
Fungicidal tested
suspension
Inactivation by
dilution/
neutralisation or
filtration
406
Staphylococcus aureus CIP
4.83-Col:CIP 4.83
FM064J
Vc :
C:
104;77
91
- 7
6
10
10
Vc :
>330;>330
34;57
8
4,55
N 10
7
4,55
N0 10
Non calculable
Q :
- 7
6
10
10
>330;>330
31;49
8
4,00
N 10
7
4,00
N0 10
Non calculable
Q :
Vc :
- 7
6
10
10
>330;>330
47;31
8
3,90
N 10
7
3,90
N0 10
Non calculable
Q :
Vc :
Operating method at the concentration %
Vc :
Na :
R(lg)) :
Vc :
Na :
R(lg)) :
Vc :
Na :
R(lg)) :
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
0,1
50
80
>330;>330
>3300
0;0
<140
0;0
<140
R<5
R>5
R>5
>330;>330
>3300
0;0
<140
0;0
<140
R<5
R>5
R>5
>330;>330
>3300
0;0
<140
0;0
<140
R<5
R>5
R>5
MH
L
LABORATOIRE DE
MICROBIOLOGIE
ET D’HYGIENE
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
Test certificate N°
1872-1
First print date :28/05/10
Print date :23/06/10
Conclusion :
4/4
In conformity with the norm NF EN 1656 (March 2010), 04/26/02/10 batch of IODERM PSP product of HYPRED SA firm,
when diluted to 50% (V/V) in presence of skimmed milk 1%, presents a bactericidal activity, for 5 minutes contact time, at
30°C , towards the strain(s) : Staphylococcus aureus CIP 4.83, Escherichia coli CIP 54.127, Streptococcus uberis CIP
103219.
Strains are preserved and checked according to EN 12353.
Comments :
Written by:
Approved by:
A-F. GABILLET
M. SESQUES
Testing officer
Technical director
on : 23/06/10
on : 23/06/10
Signature :
Signature :
MH
L
LABORATOIRE DE
MICROBIOLOGIE
ET D’HYGIENE
FM064J
First 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
Print date :25/11/10
1/4
Test certificate N° 1998 -1
Yeasticidal efficiency test according
to the norm : NF EN 1657 (April 2006)
Address :
Address : HYPRED
SA
Customer identity
Name : HYPRED SA
Address : 55 bd Jules Verger
35803
Tel :
Dinard Cedex
Fax :
E-mail : idemoment@roullier.com
Contact :
Surname : DEMOMENT
Tel: 0299165035
First name Isabelle
Fax : 0299165275
Product :
Codification :
1171
Batch number : 11/03/16/10
IODERM PSP
E-mail: idemoment@roullier.com
MH
L
FM064J
LABORATOIRE DE
MICROBIOLOGIE
ET D’HYGIENE
55 Bd Jules Verger - 35 803 DINARD Cedex
Tél : +33 (0)2 99 16 50 72 - Fax : +33 (0)2 99 16 52 75
Test certificate N° 1998 -1
First print date :19/11/10
Print date :25/11/10
2/4
Sample
Sample identification
identification
Name of the product :
IODERM PSP
1171
Batch : 11/03/16/10
Appearance : thick brown product
Receipt date : 15/11/10
Date of manufacture : 04/11/10
Expiration date :04/11/11
Active principle:
Not filled
Diluent of the product recommended by the manufacturer : Tap water
Identification
Identification of
of the
the used
used method
method ::
Method : 150
NF EN 1657 (Avril 2006)
Test method : Dilution / neutralization
Strain(s)
Neutralizing agent
Candida albicans DSM 1386-Col:1386
B neutralizer
Appearance :
B neutralizer : (3 %) Polysorbate 80 (ml); (3 %) Saponine (g); (0,3 %) Lecithin (g); (0,1 %) L-Histidin (g); (0,5 %) Sodium thiosulphate (g)
Experimental conditions :
Test manager :A-F. GABILLET
Start of analysis :
17/11/10
End of analysis :
19/11/10
Tested concentrations of the product : 0,1
50
80
Interfering substance :
Contact time :
Test temperature :
Incubation temperature :
%
(V/V)
164 skimmed milk 1%
5 (min)
30 (°C)
30 (°C)
Diluent described in the norm : Distilled water
Stability of the mixture of interfering substance and diluted product : No precipitate during assay
MH
L
LABORATOIRE DE
MICROBIOLOGIE
ET D’HYGIENE
Test certificate N° 1998 -1
55 Bd Jules Verger - 35 803 DINARD Cedex
Tél : 02 99 16 50 72 - Fax : 02 99 16 52 75
First print date : 19/11/10
Print date : 25/11/10
3/4
Results
Tested strain(s)
Validation test
Bactericidal or
Fungicidal
suspension
Experimental
conditions
Non
toxicité du
Non toxicity of
neutralisant
ou témoin
the neutraliser
de filtration
or reference
filtration
Bactericidal or
Fungicidal tested
suspension
Inactivation by
dilution/
neutralisation or
filtration
403
Candida albicans DSM 1386Col:1386
Vc :
50;46
Nv:
480
Nv0:
48
Vc :
A:
FM064J
75;78
77
Vc :
B:
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
50;51
51
Vc :
C:
33;38
36
Vc :
7
N 10
6
N0 10
Q :
5
10
188;169
1,82
1,82
OK
- 6
10
22;23
Operating method at the concentration %
Vc :
Na :
R(lg)) :
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
0,1
50
80
>330;>330
>3300
0;0
<140
0;0
<140
R<4
R>4
R>4
MH
L
LABORATOIRE DE
MICROBIOLOGIE
ET D’HYGIENE
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
Test certificate N°
1998-1
First print date :19/11/10
Print date :25/11/10
Conclusion :
4/4
According to the norm NF EN 1657 (April 2006), 11/03/16/10 batch of IODERM PSP product of HYPRED SA firm, when
diluted to 50% (V/V) in presence of skimmed milk 1%, presents a yeasticidal activity, for 5 minutes contact time, at 30°C ,
towards the strain(s) : Candida albicans DSM 1386.
Strains are preserved and checked according to EN 12353.
Comments :
Written by:
Approved by:
A-F. GABILLET
M. SESQUES
Testing officer
Technical director
on : 25/11/10
on : 25/11/10
Signature :
Signature :
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