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...

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

[email protected]

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


Sample identification

1155Name of the product :

Batch : 07/08/03/10

Active principle:


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


FM064J

Expiration date :08/07/11


Not filled

Identification of the used method :


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


de filtration


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


4,45

4,45Na : <140 <140 <140 <140 <140

R(lg)) : R>5 R>5 R>5 R>5 R>5


de filtration


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


5,40

5,40Na : <140 <140 <140 <140 <140

R(lg)) : R>5 R>5 R>5 R>5 R>5


de filtration


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


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


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 :


Tel:


Fax : E-mail:

55 bd Jules Verger

35803 Dinard Cedex

[email protected]

DEMOMENT Isabelle

0299165035 0299165275 [email protected]

1155Codification :


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


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)




Batch : 07/08/03/10

Active principle:


Receipt date :


13/09/10

08/07/10


LABORATOIRE DE

MICROBIOLOGIE

ET D’HYGIENELMH

2/7

PODOCUR SV



FM064K



Not filled




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


B neutralizer : (3 %) Polysorbate 80 (ml); (3 %) Saponine (g); (0,3 %) Lecithin (g); (0,1 %) L-Histidin (g); (0,5 %) Sodium thiosulphate (g)



5 8 10 15

10

15Contact time :

Test temperature :



(min)

(°C)

%






Stability of the mixture of interfering substance and diluted product : not concerned


(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 :


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


-

4

10- 4

10- 4

10- 1

10- 1

10- 1

10- 1

10- 1

10-


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


-

5

10- 5

10- 5

10- 2

10- 2

10- 2

10- 2

10- 2

10-


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


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




suspension


LABORATOIRE DE

MICROBIOLOGIE


Results

-1

09/12/10

4/7

09/12/10

Print date :


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-


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


-

4

10- 4

10- 4

10- 1

10- 1

10- 1

10- 1

10- 1

10-


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


-

5

10- 5

10- 5

10- 2

10- 2

10- 2

10- 2

10- 2

10-


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


710

8- -10

Nts: >100

Nts: >100 0 0 0

B: A:

R:



5 8 10 15




suspension


LABORATOIRE DE

MICROBIOLOGIE


Results

-1

09/12/10

5/7

09/12/10

Print date :


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-


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


-

4

10- 4

10- 4

10- 1

10- 1

10- 1

10- 1

10- 1

10-


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


-

5

10- 5

10- 5

10- 2

10- 2

10- 2

10- 2

10- 2

10-


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


710

8- -10

Nts: 46

Nts: 0 0 0 0

B: A:

R:



5 8 10 15




suspension


LABORATOIRE DE

MICROBIOLOGIE


Results

-1

09/12/10

6/7

09/12/10

Print date :


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-


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


-

4

10- 4

10- 4

10- 1

10- 1

10- 1

10- 1

10- 1

10-


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


-

5

10- 5

10- 5

10- 2

10- 2

10- 2

10- 2

10- 2

10-


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


710

8- -10

Nts: >100

Nts: 0 0 0 0

B: A:

R:




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 :


Tél : +33 (0)2 99 16 50 72 - Fax : +33 (0)2 99 16 52 75



FM064K

Product :

Contact :


Customer identity

Name : HYPRED SA

Address :


Tel:


Fax : E-mail:

55 bd Jules Verger

35803 Dinard Cedex

[email protected]

DEMOMENT Isabelle

0299165035 0299165275 [email protected]

1155Codification :



Yeasticidal


LABORATOIRE DE

MICROBIOLOGIE

ET D’HYGIENELMH

1/4

Address :

HYPRED SAAddress :

PODOCUR SV

-1

to the norm : NF EN 1657 (April 2006)


efficiency test according

FM064J




Batch : 07/08/03/10

Active principle:


Receipt date :


13/09/10

08/07/10


LABORATOIRE DE

MICROBIOLOGIE

ET D’HYGIENELMH

2/4

PODOCUR SV



FM064J



Not filled




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 :


1 5 8 10

10

15Contact time :

Test temperature :



(min)

(°C)

%






Stability of the mixture of interfering substance and diluted product : No precipitate during assay


(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


Results

Print date :

First print date :

FM064J


de filtration


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


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


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 :


Tél : +33 (0)2 99 16 50 72 - Fax : +33 (0)2 99 16 52 75



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



Tél. 02 99 16 50 72



2/4



- 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



Tél. 02 99 16 50 72



3/4



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



Tél. 02 99 16 50 72



4/4



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

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...

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