Test certificate N°1252

Transcription

MH
L
LABORATOIRE DE
MICROBIOLOGIE
ET D’HYGIENE
FM 064G -2
First print date : 21/12/07
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 : 18/07/08
1/4
Bactericidal efficiency test according
to the norm NF
: EN 1276 (October 1997)
Address :
Address :
HYPRED SA
Customer identity
Name : HYPRED DISTRI
Address : 55 boulevard Jules Verger
35803
DINARD Cedex
Tel : 02 99 16 50 04
Fax : 02 99 16 50 20
E-mail : [email protected]
Contact :
Surname : BOSSARD
Tel:
First name Sébastien
02 99 16 51 05
Fax :
E-mail: [email protected]
Product :
Codification :
783
DEPTIL MYCOCIDE S
Batch number : RP93
Accreditation :
Accreditation
N° 1-1308
Accreditation of COFRAC test 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
FM 064G -2
LABORATOIRE DE
MICROBIOLOGIE
ET D’HYGIENE
2257
Tél : +33 (0)2 99 16 50 72 - Fax : +33 (0)2 99 16 52
75
Test certificate N° 1252
2/4
Sample identification
Name of the product :
783
DEPTIL MYCOCIDE S
Batch : RP93
Appearance : Transparent limpid product
Receipt date : 09/11/07
Date of manufacture : 8/11/07
Active principle:
quaternary ammonium
Diluent of the product recommended by the manufacturer : Tap water
Identification of the used method :
Method :
101 NF EN 1276 (Octobre 1997)
Test method : Dilution / neutralization
Strain(s)
Neutralizing agent
Enterococcus hirae CIP 58.55-Col:CIP 58.55
Escherichia coli CIP 54.127-Col:CIP 54.127
Pseudomonas aeruginosa DSM 939-Col:939
Staphylococcus aureus CIP 4.83-Col:CIP 4.83
B neutralizer
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 :
19/12/07
End of analysis :
21/12/07
Tested concentrations of the product :
Interfering substance :
0,01
0,1
0,2
0,3
0,4
in % (V/V)
134 Bovine albumin 0,3 g/l
Contact time :
Test temperature :
Incubation temperature :
5 (in mn)
20 (in °C)
37 (in °C)
Diluent described in the norm : Hard water
Stability of the mixture of interfering substance and diluted product : No precipitate during assay
MH
L
LABORATOIRE DE
MICROBIOLOGIE
ET D’HYGIENE
FM 064H -2
55 Bd Jules Verger - 35 803 DINARD
Cedex
Tél : 02 99 16 50 72 - Fax : 02 99 16 52
3/4
Results
Tested strain(s)
Validation test
Bactericidal or!
Fungicidal!
suspension
Experimental!
conditions
Non
Nontoxicité
toxicity du
of!
neutralisant
ou
the neutraliser
!
témoin
de filtration
or reference
filtration
Bactericidal or!
Fungicidal tested!
suspension!
Inactivation by
dilution/!
neutralisation or
filtration
328
Enterococcus hirae CIP
58.55-Col:CIP 58.55
Vc :
Nv:
228;221
2245
Vc :
A:
233;222
228
Vc :
161;158
Non
160 du
B: toxicité
neutralisant ou
témoin de filtration
Vc :
C:
181;204
193
Vc :
N:
N10 7
N10 8
327
Escherichia coli CIP 54.127Col:CIP 54.127
Vc :
Nv:
143;166
1545
Vc :
A:
145;158
152
Vc :
145;127
Non
136 du
B: toxicité
neutralisant ou
Vc :
C:
110;133
122
Vc :
N:
N10 7
N10 8
330
Pseudomonas aeruginosa
DSM 939-Col:939
Vc :
Nv:
109;96
1025
Vc :
A:
253;210
232
Vc :
115;148
Non
132 du
B: toxicité
neutralisant ou
Vc :
Vc :
Vc :
C:
186;190
188
Vc :
N:
N10 7
N10 8
326
Staphylococcus aureus CIP
4.83-Col:CIP 4.83
Vc :
Nv:
146;155
1505
Vc :
Vc : Number of colonies on Petri dishes!
N : CFU in the microbial tested suspension!
Nv : CFU in the validation suspension!
Na : CFU in assay mix!
R : Viable cell reduction!
A : CFU in experimental conditions!
B : CFU in neutralizer non toxicity or filtration validation!
C : CFU in dilution/neutralization or filtration validation
A:
155;155
155
B:
121;135
128
C:
108;124
116
Vc :
N:
N10 7
N10 8
- 7
6
10
10
>300;>300
46;39
425 000 000
42,5
4,3
- 7
6
10
10
>300;>300
38;29
335 000 000
33,5
3,4
- 7
6
10
10
>300;>300
28;16
220 000 000
22
2,2
- 7
6
10
10
>300;>300
36;28
320 000 000
32
3,2
Operating method at the concentration %
0,01
0,1
0,2
0,3
0,4
Vc :
Na:
4
10
10 5
65;65
650
6,5
0,7
0;0
< 150
R>10E4
R>10E5
0;0
< 150
R>10E4
R>10E5
0;0
< 150
R>10E4
R>10E5
0;0
< 150
R>10E4
R>10E5
Vc :
Na:
4
10
10 5
>300;>300
>3000
R<10E4
R<10E5
>300;>300
>3000
R<10E4
R<10E5
23;4
< 150
R>10E4
R>10E5
0;0
< 150
R>10E4
R>10E5
2;0
< 150
R>10E4
R>10E5
Vc :
Na:
4
10
10 5
>300;>300
>3000
R<10E4
R<10E5
>300;>300
>3000
R<10E4
R<10E5
2;0
< 150
R>10E4
R>10E5
0;0
< 150
R>10E4
R>10E5
0;0
< 150
R>10E4
R>10E5
Vc :
Na:
4
10
10 5
>300;>300
>3000
R<10E4
R<10E5
0;0
< 150
R>10E4
R>10E5
0;0
< 150
R>10E4
R>10E5
0;0
< 150
R>10E4
R>10E5
0;0
< 150
R>10E4
R>10E5
MH
L
LABORATOIRE DE
MICROBIOLOGIE
ET D’HYGIENE
Tél : +33 (0)2 99 16 50 72 - Fax : +33 (0)2 99 16 52
75
FM 064G -2
Conclusion :
4/4
In conformity with the norm NF EN 1276 (October 1997), RP93 batch of DEPTIL MYCOCIDE S product of HYPRED
DISTRI firm, when diluted at 0,2% (V/V) in presence of Bovine albumin 0,3 g/l, presents a bactericidal activity
for 5 minutes contact time, at 20 °C , towards the strain(s) : Enterococcus hirae CIP 58.55,Escherichia coli CIP
54.127,Pseudomonas aeruginosa DSM 939,Staphylococcus aureus CIP 4.83.
Strains are preserved and checked according to EN 12353.
Comments :
Written by:
A-F. GABILLET
Approved by:
M. THERAUD
on : 18/07/08
on : 18/07/08
Signature :
Signature :
TEST REPORT
MA-804.729 (GU)
Page 1de9
Client identification:
Name:
Address:
City/town:
Province:
Postcode:
A / A:
Client code:
HYPRED IBERICA, S.L.
Pol. Arazuri Orcoyen- Calle C,32
Orcoyen
Navarra
31160
Date control:
Incoming:
Starting:
Finished:
96
Sample identification:
Product: FEPTIL MICOCIDE S 11.03.04.08 BIDON 0020
12-03-09
Sampling date:
Room temperature
Temperature on arrival:
"Sample has been provided by client"
DETERMINATIONS :
BACTERICIDAL ACTIVITY (UNE-EN 13697)
Page: 2
CHARTS: S1,S2,S3 and S4
Pages: 4,5,6 and 7
FUNGICIDAL ACTIVITY (UNE-EN 13697)
Page. 3
CHARTS: S5 and S6
Pages: 8 and 9
12-03-2009
16-03-2009
21-03-2009
MA-804.729 (GU)
Page 2 of 9
BACTERICIDAL ACTIVITY (UNE-EN 13697):
Bactericidal activity on surfaces in general utilization conditions (for clean conditions)
a) Test laboratory identification:
b) Sample identification:
Reference inhouse number:
Name of the product:
Batch number:
Manufacturer:
Delivery date:
Storage conditions:
Product diluent, recommended by the manufacturer:
Active substance(s) and its (their) concentration(s):
c) Test method and its validation:
Method:
Neutralizer:
d) Experimental conditions:
Test period:
Product diluent used during the test:
Product test concentrations:
Test temperature:
Product dilutions appearance:
Interferential substance:
Stability of the mixture (interferential substance and
products dissolved in hard water)
Contact time:
Incubation temperature:
Identification of bacterial strains used:
Biotecnal, S.A.
MA-804.729 (GU)
DEPTIL MICOCIDE S 11.03.4.08 BIDON0020
HYPRED IBERICA, S.L.
12-03-09
Room temperature
Potable water
Didecil dimetil ammonium chloride (2%)
Dilution- Neutralization
Neutralizer broth D/E
16-03-09 to 21-03-09
Sterile hard water
0.02%, 0.2%, 2.5% (v/v)
23±1ºC
Transparent, colourless solutions
0,3g/l bovine albumen aqueous solution
Absence of precipitates during the test
5 minutes ± 10 seconds
37 ± 1ºC
Pseudomonas aeruginosa CECT-116
Escherichia coli CECT-405
Staphylococcus aureus CECT-59
Enterococcus hirae CECT-4081
e) Test results:
(See charts S1,S2,S3,S4)
f) Conclusion:
According to EN 13697 (2001), the batch / of the product “Deptil micocide S 11.03.04.08 Bidon 0020” (MA-804.729(GU))
when it is dissolved to 0,2% (v/v) in hard water, it has a bactericidal activity on surfaces after 5 minutes at 20ºC in dirty
conditions (0,3g/l of bovine albumen) against reference strains: Pseudomonas aeruginosa CECT-116, Escherichia coli
CECT-405, Staphylococcus aureus CECT-59, Enterococcus hirae CECT-4081.
MA-804.729 (GU)
Page 3 of 9
FUNGICIDAL ACTIVITY (UNE-EN 13697):
Fungicidal activity on surfaces in general use conditions (for clean conditions)
a) Test laboratory identification:
Biotecnal, S.A.
b) Sample identification:
Reference inhouse number:
Name of the product:
Batch number:
Manufacturer:
Delivery date:
Storage conditions:
Product diluent, recommended by the manufacturer:
Active substance(s) and its (their) concentration(s):
MA-804.729(GU)
DEPTIL MICOCIDE S 11.03.04.08 Bidon 0020
/
HYPRED IBERICA, S.A.
12-03-09
Room temperature
Potable water
Didecil dimetil ammonium chloride (2%)
c) Test method and its validation:
Method:
Neutralizer:
Dilution- Neutralization
Neutralizer broth D/E
d) Experimental conditions:
Test period:
Product diluent used during the test:
Product test concentrations:
Test temperature:
Product dilutions appearance:
Interferential substance:
Stability of the mixture (interferential substance and
products dissolved in hard water)
Contact time:
Incubation temperature:
Identification of bacterial strains used:
16-03-08 to 21/03/09
Sterile hard water
0,2%, 0.2%, 2.5% (v/v)
23 ± 1ºC
Transparent, colourless solutions
0,3g/l bovine albumen aqueous solution
Absence of precipitates during the test
15 minutes ± 10 seconds
30 ± 1ºC
Candida albicans CECT-1394
Aspergillus niger CECT-2574
e) Test results:
(See charts S5, S6)
f) Conclusion:
According to EN 13697 (2001) the batch / of the product “Didecil miocide S 11.03.04.08 Bidon 0020” (MA-804.729(GU))
when it is dissolved to 0,2% (v/v) in hard water, it has a fungicidal activity on surfaces after 15 minutes at 23ºC in dirty
conditions (0,3g/l of bovine albumen) against reference strains: Candida albicans CECT-1394, Aspergillus niger CECT2574.
MA-804.729 (GU)
Page 4 of 9
CHART S-1
PSEUDOMONAS AERUGINOSA CECT - 116 (MR-84)
VALIDATION TEST:
TEST BACTERIAL
SUSPENSION: N
NT
NC
10-3 >300 - >300
10-3 >300 - >300
10-6: >300 - >300
10-4: >300 - >300
10-4 >300 - >300
10-7: 41-38
10-5: 68-75
10-5: 54-63
N: 7.30
NT: 7.85
NC: 7.77
WATER CONTROL:
TEST METHOD:
NC
10-3 >300 ->300
-4:
10
>300 - >300
NI
ND
NS
0.02%
0.2%
2.5%
10-0 >300->300
-1
10
241-230
10-0: >300 - >300
-1:
10
41-36
10-0:38-33
10-1:4-4
10-5: 59-61
10-2 25-25
10-2: 4-5
10-2:0-1
10-6: 6-6
Ni: 4.37
Nd: 3,59
NS: 2,55
Nts: 3
Nts:0
ME: 4.58
ME: 7.68
Nc: 7.78
ME 3.41
MA-804.729 (GU)
Page 5 of 9
CHART
S-2
ESCHRICHIA COLI CECT - 405 (MR-22)
VALIDATION TEST:
TEST BACTERIAL
SUSPENSION: N
NT
10-3 >300 - >300
-6:
10
295-281
-4:
10
>300 - >300
NC
10-3 >300 - >300
10-4: >300 - >300
10-7: 19-30
10-5: 40-48
10-5: 40-37
N: 7.16
NT: 7.64
NC: 7.59
WATER CONTROL:
TEST METHOD:
NC
NI
ND
NS
0.02%
0.2%
2.5%
10-3 >300 ->300
10-0 >300->300
10-0: 294-297
10-0: 0-0
10-4: >300 - >300
10-1 188-200
10-1: 32-30
10-1: 0-0
10-5: 41-45
10-2 20-20
10-2: 4-3
10-2: 0-0
Ni: 4.29
Nd: 3,49
NS: <0.10
Nts: 5
Nts: 0
ME: 4.59
ME: 7.53
-6
10 : 4-3
Nc: 7.63
ME 3.34
MA-804.729 (GU)
Page 6 of 9
CHART
S-3
STAPHYLOCOCCUS AUREUS CECT - 59 (MR-31)
VALIDATION TEST:
TEST BACTERIAL
SUSPENSION: N
NT
10-3 >300 - >300
-6:
10
206-198
-4:
10
216-222
NC
10-3 >300 - >300
10-4: 220-225
10-7: 21-20
10-5: 22-22
10-5: 23-22
N: 7.00
NT: 7.34
NC: 7.35
WATER CONTROL:
TEST METHOD:
NC
NI
ND
NS
0.02%
0.2%
2.5%
10-3 >300 ->300
10-0 >300 ->300
10-0: 184-175
10-0: 0-0
10-4: 181-183
10-1 >300 ->300
10-1: 19-18
10-1: 0-0
10-5: 19-20
10-2 56-40
10-2: 2-2
10-2: 0-0
Ni: 4.68
Nd: 3.25
NS: <0.10
Nts: 33
Nts:0
ME: 4.02
ME: 7.17
-6
10 : 2-2
Nc: 7.27
ME 2.59
MA-804.729 (GU)
Page 7 of 9
CHART
S-4
ENTEROCOCCUS HIRAE CECT - 4081 (MR-85)
VALIDATION TEST:
TEST BACTERIAL
SUSPENSION: N
NT
NC
10-3 >300 - >300
10-3 >300 - >300
10-6: 240-253
10-4: 200-196
10-4: >300 - >300
10-7: 25-25
10-5: 30-33
10-5: 27-32
N: 7.09
NT: 7.50
NC: 7.47
WATER CONTROL:
TEST METHOD:
NC
NI
ND
NS
0,25%
0,5%
1%
10-3 >300 ->300
10-0 >300->300
10-0: 148-157
10-0: 0-0
10-4: >300 ->300
10-1 209-211
10-1: 15-18
10-1: 0-0
-5
-2
10 : 29-35
10
21-20
10-6: 3-3
Ni: 4.32
-2:
10
2-2
10-2: 0-0
Nd: 3.18
NS: <0.10
Nts: 15
Nts:0
ME: 4.32
ME: 7.41
Nc: 7.51
ME 3.19
MA-804.729 (GU)
Page 8 of 9
CHART
S-5
ASPERGILLUS NIGER CECT - 2574 (MR-69)
VALIDATION TEST:
TEST FUNGICAL
SUSPENSION: N
10-5: >150->150
-6:
10
18-21
N: 5.99
NT
NC
10-2: >150->150
10-2: >150->150
10-3: 56-68
10-3: 61-60
-4:
10
10-4 6-5
6-7
NT: 5.79
NC: 5.78
WATER CONTROL:
TEST METHOD:
NC
NI
ND
NS
0.02%
0.2%
2.5%
10-2:>150->150
10-0: >150->150
10-0: >150->150
10-0: 0-0
10-3:>150->150
10-1: >150->150
10-1: 17-16
10-1: 0-0
10-4 71-69
10-2: 47-18
10-2:1-3
10-2: 0-0
10-5: 7-7
Ni: 4.24
Nd :3.22
Ns: <0.10
Nts:5
Nts:0
ME: 3.63
ME: 6.75
Nc: 6.85
ME: 2.60
MA-804.729 (GU)
Page 9 of 9
CHART
S-6
CANDIDA ALBICANS CECT – 1394 (MR-70)
VALIDATION TEST:
TEST FUNGICAL
SUSPENSION: N
NT
10-2: >150->150
-5:
10
>150->150
-3:
10
142-149
NC
10-2: >150->150
10-3: >150->150
10-6: 44-44
10-4:15-14
10-4 17-19
N: 6.34
NT: 6.16
NC: 6.26
WATER CONTROL:
TEST METHOD:
NC
NI
ND
NS
0,5%
1%
2%
10-2:>150->150
10-0: >150->150
10-0: >261->249
10-0: 0-0
10-3:>150->150
10-1: >150->150
10-1: 27-25
10-1: 0-0
10-4 149-144
10-2: 48-42
10-2:2-3
10-2: 0-0
Ni: 4.65
ND :3.41
Ns: <0.10
Nts:13
Nts:0
ME: 3.75
ME: 7.7
-5:
10
15-15
Nc: 7.17
ME: 2.51
Sant Quirze del Vallès, 30th March 2009
Carisia Ventura Cebrià
Technical Manager
Important:
- This test report only affects the sample which was received and analysed.
- It is strictly forbidden to make partial or complete copies of this report without Biotecnal written approval.
- Laboratory credited by ENAC with 408/LE 1342 accreditation number.
MH
L
LABORATOIRE DE
MICROBIOLOGIE
ET D’HYGIENE
FM 064G -4
Tél : +33 (0)2 99 16 50 72 - Fax : +33 (0)2 99 16 52
75
1/4
Fungicidal efficiency test according
to the norm NF
: EN 1650 (May 1998)
Part
Address :
Address :
HYPRED SA
Customer identity
Name : HYPRED SA
Address : 55 Bd Jules verger
35 803
DINARD Cedex
Tel : 02-99-16-50-00
Fax : 02-99-16-50-20
E-mail : [email protected]
Contact :
Surname : DEMOMENT
Tel:
First name Isabelle
02-99-16-50-35
Fax : 02-99-16-52-75
E-mail: [email protected]
Product :
Codification :
851
DEPTIL MYCOCIDE S
Batch number : 05.16.98.08
Accreditation :
Accreditation
N° 1-1308
Accreditation of COFRAC test 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
FM 064G -4
LABORATOIRE DE
MICROBIOLOGIE
ET D’HYGIENE
2418
Tél : +33 (0)2 99 16 50 72 - Fax : +33 (0)2 99 16 52
75
2/4
851
DEPTIL MYCOCIDE S
Batch : 05.16.98.08
Appearance : transparent product
Active principle:
didecyl dimethyl ammonium
Method :
102 NF EN 1650 (Mai 1998)
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)
Test manager : M. THERAUD
Start of analysis :
21/05/08
End of analysis :
23/05/08
0,01
0,05
0,1
0,2
0,5
in % (V/V)
134 Bovine albumin 0,3 g/l
Contact time :
Test temperature :
15 (in mn)
20 (in °C)
30 (in °C)
MH
L
LABORATOIRE DE
MICROBIOLOGIE
ET D’HYGIENE
FM 064H -4
55 Bd Jules Verger - 35 803 DINARD
Cedex
Tél : 02 99 16 50 72 - Fax : 02 99 16 52
3/4
Results
Tested strain(s)
Validation test
Bactericidal or!
Fungicidal!
suspension
Experimental!
conditions
Non
Nontoxicité
toxicity du
of!
neutralisant
ou
the neutraliser
!
témoin
de filtration
or reference
filtration
Bactericidal or!
Fungicidal tested!
suspension!
Inactivation by
dilution/!
neutralisation or
filtration
332
Candida albicans DSM 1386Col:1386
Vc :
Nv:
143;146
1445
Vc :
Vc : Number of colonies on Petri dishes!
N : CFU in the microbial tested suspension!
Nv : CFU in the validation suspension!
Na : CFU in assay mix!
R : Viable cell reduction!
A : CFU in experimental conditions!
B : CFU in neutralizer non toxicity or filtration validation!
C : CFU in dilution/neutralization or filtration validation
A:
107;114
111
Vc :
B:
133;106
120
Vc :
C:
136;133
135
Vc :
N:
N10 7
N10 8
- 6
5
10
10
>150;>150
27;27
27 000 000
2,7
0,3
0,01
Vc :
Na:
4
10
10 5
>150;>150
>1500
R<10E4
R<10E5
0,05
10;14
< 150
R>10E4
R>10E5
0,1
0;0
< 150
R>10E4
R>10E5
0,2
0;0
< 150
R>10E4
R>10E5
0,5
0;0
< 150
R>10E4
R>10E5
MH
L
LABORATOIRE DE
MICROBIOLOGIE
ET D’HYGIENE
Tél : +33 (0)2 99 16 50 72 - Fax : +33 (0)2 99 16 52
75
FM 064G -4
Conclusion :
4/4
In conformity with the norm NF EN 1650 (May 1998), 05.16.98.08 batch of DEPTIL MYCOCIDE S product of
HYPRED SA firm, when diluted at 0,05% (V/V) in presence of Bovine albumin 0,3 g/l, presents a fungicidal
activity for 15 minutes contact time, at 20 °C , towards the strain(s) : Candida albicans DSM 1386.
Strains are preserved and checked according to EN 12353.
Comments :
Written by:
M. THERAUD
Approved by:
A-F. GABILLET
on : 18/07/08
on : 18/07/08
Signature :
Signature :
MH
L
LABORATOIRE DE
MICROBIOLOGIE
ET D’HYGIENE
FM 064G
Tél : +33 (0)2 99 16 50 72 - Fax : +33 (0)2 99 16 52 75
Print date : 03/12/2007
1/4
efficiency test according
to the norm : NF EN 13610 (July 2003)
Address :
Address :
HYPRED SA
Name :
HYPRED DISTRI
Customer identity
Address : 55 Bd Jules Verger
35 803
Tel :
DINARD Cedex
02-99-16-50-00
Fax : 02-99-16-50-20
E-mail :
Contact :
Surname :
Tel:
First name Pierre
LAILLIER
02-99-16-50-05
Fax :
02-99-16-50-20
Product :
Codification :
472
Batch number : NP09
DEPTIL MYCOCIDE S
E-mail:
MH
L
FM064G
LABORATOIRE DE
MICROBIOLOGIE
ET D’HYGIENE
1
Tél : +33 (0)2 99 16 50 72 - Fax : +33 (0)2 99 16 52 75
Test certificate N°
654 -
Print date : 03/12/2007
2/4
DEPTIL MYCOCIDE S
472
Batch : NP09
Appearance : Transparent limpid product
Active principle:
Not filled
Method :
146
NF EN 13610 (Juillet 2003)
Strain(s)
Neutralizing agent
Phage P001-Col:4262
Phage P008-Col:10567
J neutralizer
J neutralizer
Appearance :
J neutralizer : (3 %) Polysorbate 80 (ml); (0,3 %) Sodium thiosulphate (g); (0,3 %) L-Histidin (g); (0,3 %) L-Cystein (g); (50 %) M17 broth (double concentrated) (ml)
Test manager : M. THERAUD
Start of analysis :
29/07/2005
End of analysis :
04/08/2005
Contact time :
Test temperature :
0,05
0,1
0,2
0,5
%
(V/V)
251 10% curd
15 (min)
20 (°C)
30 (°C)
MH
L
LABORATOIRE DE
MICROBIOLOGIE
ET D’HYGIENE
FM064G
Tél : 02 99 16 50 72 - Fax : 02 99 16 52 75
654 -1
Print date : 03/12/2007
Results
3/4
Tested strain(s)
Validation test
Virucidal
suspension
10E-1 :
10E0 :
253
Phage P001-Col:4262
Pc :
Pc :
Nv:
56;46
>300;>300
51000
Experimental
conditions
Pc :
Pc :
A:
50;59
>300;>300
5450
Non toxicity of
the neutraliser
or reference filtration
Pc :
Pc :
B:
8;9
131;171
1510
Virucidal tested
suspension
Inactivation by
dilution/
neutralisation or
filtration
Pc :
Pc :
C:
11;11
-
>300;278
2780
Pc :
10E0 :
254
Phage P008-Col:10567
Pc :
52;64
Pc :
>300;>300
Nv:
58000
Pc :
Pc :
A:
65;57
>300;>300
6100
Pc :
Pc :
B:
10;10
127;138
1325
Pc :
Pc :
C:
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
9
-
10
12;10
7
-
112;145
1329
Pc :
6
10
200;242
9
: 2,23
-
7
10
20;29
0,1
0,2
0,5
4;0
Pc :
8;8
5;0
0;0
Pc :
>300;86
1;0
0;3
0;0
Na:
43000
<7,5.10E3
<7,5.10E3
<7,5.10E3
0,3
R>10E4
R>10E4
R>10E4
Pc :
16;29
0;0
0;0
0;0
Pc :
114;125
0;0
0;0
0;0
Na:
64500
<7,5.10E3
<7,5.10E3
<7,5.10E3
0,3
R>10E4
R>10E4
R>10E4
R.10
: 1,24
8;22
N.10
Pc : number of plaque-forming unit(s) per plate
N : number of PFU/ml in the test suspension
Nv : number of PFU/ml in the validation suspension
Na : number of PFU/ml in the test mixture
6
10
107;140
N.10
10E-1 :
0,05
R.10
4
4
A test is validated for :
N between 8.10^8 - 3.10^9
Nv between 2.10^4 - 1.10^5
A equal to or greater than 0,05*Nv
B equal to or greater than 0,01*Nv (by dilution) or 0,05*Nv (by filtration)
C equal to or greater than 0,5*B
MH
L
FM 064G
LABORATOIRE DE
MICROBIOLOGIE
ET D’HYGIENE
Tél : +33 (0)2 99 16 50 72 - Fax : +33 (0)2 99 16 52 75
654
Print date : 03/12/2007
4/4
In conformity with the norm NF EN 13610 (July 2003), NP09 batch of DEPTIL MYCOCIDE S product of HYPRED DISTRI
firm, when diluted to 0.1% (V/V) in presence of 10% curd, presents a virucidal activity for 15 minute contact time, at 20 °
C, towards the phages P001 (DSM 4262) and P008 (DSM 10567), lytic for L. lactis spp lactis (DSM 4366 - preserved
according to EN 12353).
Conclusion :
Written by:
M. THERAUD
Approved by:
A-F. GABILLET
on : 3/12/07
on : 3/12/07
Signature :
Signature :

Test certificate N°1252

Transcription

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