EN 1276: BACTERICIDAL EFFICACY FINAL TEST REPORT

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248 Jean Avenue, Lyttelton Centurion, South Africa P.O. Box 14167, Lyttelton Centurion, 0140, South Africa Contact Person: Company: Disclaimer: 622196 VITALOXIDE 18/02/2020 15/01/2020 15/01/2020 KAMEELFONTEIN PEBBLE ROCK GOLF ESTATE Batch Number: Active Substances: Product Identification: Product Concentrations: EN 1276: BACTERICIDAL EFFICACY Diluent Used in Test: Expiry Date: CHLORINE DIOXIDE VITAL OXIDE FINAL TEST REPORT SANS 51276:2011 - Quantitative suspension test for the evaluation of bactericidal activity of chemical disinfectants and antiseptics used in food, industrial, domestic and institutional areas. 200 MOONSTONE CRESCENT TUMELO AFRICA (PTY) LTD RENE STRYDOM Lab Number : Analysis performed by: J. JACOBS The results reported relate only to the samples tested and is expressed on an 'as received' basis unless specified otherwise. The test report shall not be reproduced except in full, without written approval of the Laboratory. 20g/L SODIUM THIOSULFATE + 5g/L LECITHIN 0.3g/L BOVINE SERUM ALBUMIN Submit Date : Sample Date : Order reference : Storage Conditions: Recommended Diluent: Appearance of Product: HOMOGENOUS SUSPENSIONS DILUTION NEUTRALISATION AMBIENT TEMPERATURE OUT OF DIRECT LIGHT 2020/05/01 2017427437 NONE SUITABLE FOR TESTING STERILE DISTILLED WATER NEAT HOMOGENOUS SUSPENSIONS Neutralizer / Rinsing Liquid: Method: Appearance during Test: Interfering Substances: Appearance of Dilutions: Report Date : 0038 LAB Number: 622196 1 of 10 Vital Oxide

Transcript of EN 1276: BACTERICIDAL EFFICACY FINAL TEST REPORT

Page 1: EN 1276: BACTERICIDAL EFFICACY FINAL TEST REPORT

248 Jean Avenue, Lyttelton

Centurion, South Africa

P.O. Box 14167, Lyttelton

Centurion, 0140, South Africa

Contact Person:

Company:

Disclaimer:

622196

VITALOXIDE

18/02/2020

15/01/2020

15/01/2020

KAMEELFONTEIN

PEBBLE ROCK GOLF ESTATE

Batch Number:

Active Substances:

Product Identification:

Product Concentrations:

EN 1276: BACTERICIDAL EFFICACY

Diluent Used in Test:

Expiry Date:

CHLORINE DIOXIDE

VITAL OXIDE

FINAL TEST REPORT

SANS 51276:2011 - Quantitative suspension test for the evaluation of bactericidal activity of chemical

disinfectants and antiseptics used in food, industrial, domestic and institutional areas.

200 MOONSTONE CRESCENT

TUMELO AFRICA (PTY) LTD

RENE STRYDOM Lab Number :

Analysis performed by: J. JACOBS

The results reported relate only to the samples tested and is expressed on an 'as received' basis unless

specified otherwise. The test report shall not be reproduced except in full, without written approval of the

Laboratory.

20g/L SODIUM THIOSULFATE + 5g/L LECITHIN

0.3g/L BOVINE SERUM ALBUMIN

Submit Date :

Sample Date :

Order reference :

Storage Conditions:

Recommended Diluent:

Appearance of Product:

HOMOGENOUS SUSPENSIONS

DILUTION NEUTRALISATION

AMBIENT TEMPERATURE OUT OF DIRECT LIGHT

2020/05/01

2017427437

NONE

SUITABLE FOR TESTING

STERILE DISTILLED WATER

NEAT

HOMOGENOUS SUSPENSIONS

Neutralizer / Rinsing Liquid:

Method:

Appearance during Test:

Interfering Substances:

Appearance of Dilutions:

Report Date :

0038

LAB Number: 622196 1 of 10 Vital Oxide

Page 2: EN 1276: BACTERICIDAL EFFICACY FINAL TEST REPORT

Conclusion:

Validations and Controls:

Johan Jacobs

Technical Advisor

All validations and controls were within specification during the test

Vital Oxide successfully achieved a 5-log reduction and achieved a >99.999% reduction in viable E.coli

ATCC10536, S.aureus ATCC6538, P.aeruginosa ATCC15442 and E.hirae ATCC10541 when applied at a

Ready-to-use concentration (80% of active substance in solution).

Tests were conducted under the obligatory conditions using 03g/L bovine serum albumin to simulate clean

conditions with a contact time of 5 minutes at a temperature of 20°C. All organisms were tested in duplicate

for verification.

LAB Number: 622196 2 of 10 Vital Oxide

Page 3: EN 1276: BACTERICIDAL EFFICACY FINAL TEST REPORT

Validation and Controls:

Test Suspension and Test:

Summary:

Test Temperature: 20°C

Incubation Temperature: 37°C

Validation suspension Experimental condition Filtration control (B ) Method Validation (C )

(Nv0) control (A)

Organism: Escherichia coli ATCC10536

Replicate: 1 of 2

Test Date: 28/01/2020

40 Vc2a 39Vc2b 26

Vc2a 23Vc2a 46 Vc2a

38 Vc1a 34Vc1b 24

Vc1a 26Vc1a 41 Vc1a

X̄≥0.5XNv0 Spec X̄≥0.5XNv0

Complies Yes Complies Yes Complies Yes Complies Yes

Spec 30≤X̄≥160 Spec X̄≥0.5XNv0 Spec

X̄ = 49.5 X̄ = 43.5 X̄ = 39 X̄ = 36.5

Yes

ProductVc1 Vc2 Na = X̄ x 10 Log Na Log R Contact time

Conc.

2.64E+08 log10N= 8.42

10-6258 266 N0 = N/10 log10N0= 7.42

Test

Suspension

(N and N0):

N Vc1 Vc2 X̄ wm =

10-726 31 7.17 ≤ LgN0 ≤ 7.70?

>6.42 5 MINUTES

10% >300 >300 >3000 >3.18 <4.24 5 MINUTES

NEAT 0 0 <10 <1

Lowest effective concentration NEAT

LAB Number: 622196 3 of 10 Vital Oxide

Page 4: EN 1276: BACTERICIDAL EFFICACY FINAL TEST REPORT

Validation and Controls:

Test Suspension and Test:

Summary:

Incubation Temperature: 37°C

Validation suspension Experimental condition Filtration control (B ) Method Validation (C )

(Nv0) control (A)

Replicate: 2 of 2

Test Date: 28/01/2020

Test Temperature: 20°C

Organism: Escherichia coli ATCC10536

34 Vc2a 36Vc2b 26

Vc2a 23Vc2a 39 Vc2a

37 Vc1a 31Vc1b 24

Vc1a 26Vc1a 43 Vc1a

X̄≥0.5XNv0 Spec X̄≥0.5XNv0

Complies Yes Complies Yes Complies Yes Complies Yes

Spec 30≤X̄≥160 Spec X̄≥0.5XNv0 Spec

X̄ = 49.5 X̄ = 41 X̄ = 35.5 X̄ = 33.5

Yes

ProductVc1 Vc2 Na = X̄ x 10 Log Na Log R Contact time

Conc.

2.64E+08 log10N= 8.42

10-6258 266 N0 = N/10 log10N0= 7.42

Test

Suspension

(N and N0):

N Vc1 Vc2 X̄ wm =

10-726 31 7.17 ≤ LgN0 ≤ 7.70?

>6.42 5 MINUTES

10% >300 >300 >3000 >3.18 <4.24 5 MINUTES

NEAT 0 0 <10 <1

Lowest effective concentration NEAT

LAB Number: 622196 4 of 10 Vital Oxide

Page 5: EN 1276: BACTERICIDAL EFFICACY FINAL TEST REPORT

Validation and Controls:

Test Suspension and Test:

Summary:

Incubation Temperature: 37°C

Validation suspension Experimental condition Filtration control (B ) Method Validation (C )

(Nv0) control (A)

Replicate: 1 of 2

Test Date: 28/01/2020

Test Temperature: 20°C

Organism: Staphylococcus aureus ATCC6538

90 Vc2a 78Vc2b 49

Vc2a 45Vc2a 99 Vc2a

84 Vc1a 73Vc1b 51

Vc1a 46Vc1a 93 Vc1a

X̄≥0.5XNv0 Spec X̄≥0.5XNv0

Complies Yes Complies Yes Complies Yes Complies Yes

Spec 30≤X̄≥160 Spec X̄≥0.5XNv0 Spec

X̄ = 95.5 X̄ = 96 X̄ = 87 X̄ = 75.5

Yes

ProductVc1 Vc2 Na = X̄ x 10 Log Na Log R Contact time

Conc.

4.05E+08 log10N= 8.61

10-6TNTC TNTC N0 = N/10 log10N0= 7.61

Test

Suspension

(N and N0):

N Vc1 Vc2 X̄ wm =

10-738 43 7.17 ≤ LgN0 ≤ 7.70?

>6.42 5 MINUTES

10% >300 >300 >3000 >3.18 <4.24 5 MINUTES

NEAT 0 0 <10 <1

Lowest effective concentration NEAT

LAB Number: 622196 5 of 10 Vital Oxide

Page 6: EN 1276: BACTERICIDAL EFFICACY FINAL TEST REPORT

Validation and Controls:

Test Suspension and Test:

Summary:

Incubation Temperature: 37°C

Validation suspension Experimental condition Filtration control (B ) Method Validation (C )

(Nv0) control (A)

Replicate: 2 of 2

Test Date: 28/01/2020

Test Temperature: 20°C

Organism: Staphylococcus aureus ATCC6538

88 Vc2a 74Vc2b 49

Vc2a 45Vc2a 92 Vc2a

83 Vc1a 81Vc1b 51

Vc1a 46Vc1a 97 Vc1a

X̄≥0.5XNv0 Spec X̄≥0.5XNv0

Complies Yes Complies Yes Complies Yes Complies Yes

Spec 30≤X̄≥160 Spec X̄≥0.5XNv0 Spec

X̄ = 95.5 X̄ = 94.5 X̄ = 85.5 X̄ = 77.5

Yes

ProductVc1 Vc2 Na = X̄ x 10 Log Na Log R Contact time

Conc.

4.05E+08 log10N= 8.61

10-6TNTC TNTC N0 = N/10 log10N0= 7.61

Test

Suspension

(N and N0):

N Vc1 Vc2 X̄ wm =

10-738 43 7.17 ≤ LgN0 ≤ 7.70?

>6.42 5 MINUTES

10% >300 >300 >3000 >3.18 <4.24 5 MINUTES

NEAT 0 0 <10 <1

Lowest effective concentration NEAT

LAB Number: 622196 6 of 10 Vital Oxide

Page 7: EN 1276: BACTERICIDAL EFFICACY FINAL TEST REPORT

Validation and Controls:

Test Suspension and Test:

Summary:

Incubation Temperature: 37°C

Validation suspension Experimental condition Filtration control (B ) Method Validation (C )

(Nv0) control (A)

Replicate: 1 of 2

Test Date: 05/02/2020

Test Temperature: 20°C

Organism: Pseudomonas aeruginosa ATCC15442

49 Vc2a 43Vc2b 28

Vc2a 35Vc2a 58 Vc2a

50 Vc1a 53Vc1b 29

Vc1a 31Vc1a 54 Vc1a

X̄≥0.5XNv0 Spec X̄≥0.5XNv0

Complies Yes Complies Yes Complies Yes Complies Yes

Spec 30≤X̄≥160 Spec X̄≥0.5XNv0 Spec

X̄ = 61.5 X̄ = 56 X̄ = 49.5 X̄ = 48

Yes

ProductVc1 Vc2 Na = X̄ x 10 Log Na Log R Contact time

Conc.

2.82E+08 log10N= 8.45

10-6288 281 N0 = N/10 log10N0= 7.45

Test

Suspension

(N and N0):

N Vc1 Vc2 X̄ wm =

10-727 24 7.17 ≤ LgN0 ≤ 7.70?

>6.42 5 MINUTES

10% >300 >300 >3000 >3.18 <4.24 5 MINUTES

NEAT 0 0 <10 <1

Lowest effective concentration NEAT

LAB Number: 622196 7 of 10 Vital Oxide

Page 8: EN 1276: BACTERICIDAL EFFICACY FINAL TEST REPORT

Validation and Controls:

Test Suspension and Test:

Summary:

Incubation Temperature: 37°C

Validation suspension Experimental condition Filtration control (B ) Method Validation (C )

(Nv0) control (A)

Replicate: 2 of 2

Test Date: 05/02/2020

Test Temperature: 20°C

Organism: Pseudomonas aeruginosa ATCC15442

50 Vc2a 47Vc2b 28

Vc2a 35Vc2a 55 Vc2a

46 Vc1a 43Vc1b 29

Vc1a 31Vc1a 51 Vc1a

X̄≥0.5XNv0 Spec X̄≥0.5XNv0

Complies Yes Complies Yes Complies Yes Complies Yes

Spec 30≤X̄≥160 Spec X̄≥0.5XNv0 Spec

X̄ = 61.5 X̄ = 53 X̄ = 48 X̄ = 45

Yes

ProductVc1 Vc2 Na = X̄ x 10 Log Na Log R Contact time

Conc.

2.82E+08 log10N= 8.45

10-6288 281 N0 = N/10 log10N0= 7.45

Test

Suspension

(N and N0):

N Vc1 Vc2 X̄ wm =

10-727 24 7.17 ≤ LgN0 ≤ 7.70?

>6.42 5 MINUTES

10% >300 >300 >3000 >3.18 <4.24 5 MINUTES

NEAT 0 0 <10 <1

Lowest effective concentration NEAT

LAB Number: 622196 8 of 10 Vital Oxide

Page 9: EN 1276: BACTERICIDAL EFFICACY FINAL TEST REPORT

Validation and Controls:

Test Suspension and Test:

Summary:

Incubation Temperature: 37°C

Validation suspension Experimental condition Filtration control (B ) Method Validation (C )

(Nv0) control (A)

Replicate: 1 of 2

Test Date: 05/08/2020

Test Temperature: 20°C

Organism: Enterococcus hirae ATCC10541

90 Vc2a 75Vc2b 47

Vc2a 56Vc2a 87 Vc2a

83 Vc1a 81Vc1b 51

Vc1a 49Vc1a 94 Vc1a

X̄≥0.5XNv0 Spec X̄≥0.5XNv0

Complies Yes Complies Yes Complies Yes Complies Yes

Spec 30≤X̄≥160 Spec X̄≥0.5XNv0 Spec

X̄ = 101.5 X̄ = 90.5 X̄ = 86.5 X̄ = 78

Yes

ProductVc1 Vc2 Na = X̄ x 10 Log Na Log R Contact time

Conc.

4.25E+08 log10N= 8.63

10-6TNTC TNTC N0 = N/10 log10N0= 7.63

Test

Suspension

(N and N0):

N Vc1 Vc2 X̄ wm =

10-746 39 7.17 ≤ LgN0 ≤ 7.70?

>6.42 5 MINUTES

10% >300 >300 >3000 >3.18 <4.24 5 MINUTES

NEAT 0 0 <10 <1

Lowest effective concentration NEAT

LAB Number: 622196 9 of 10 Vital Oxide

Page 10: EN 1276: BACTERICIDAL EFFICACY FINAL TEST REPORT

Validation and Controls:

Test Suspension and Test:

Summary:

Incubation Temperature: 37°C

Validation suspension Experimental condition Filtration control (B ) Method Validation (C )

(Nv0) control (A)

Replicate: 1 of 2

Test Date: 05/08/2020

Test Temperature: 20°C

Organism: Enterococcus hirae ATCC10541

84 Vc2a 71Vc2b 47

Vc2a 56Vc2a 93 Vc2a

86 Vc1a 76Vc1b 51

Vc1a 49Vc1a 97 Vc1a

X̄≥0.5XNv0 Spec X̄≥0.5XNv0

Complies Yes Complies Yes Complies Yes Complies Yes

Spec 30≤X̄≥160 Spec X̄≥0.5XNv0 Spec

X̄ = 101.5 X̄ = 95 X̄ = 85 X̄ = 73.5

4.25E+08 log10N= 8.63

10-6TNTC TNTC N0 = N/10 log10N0= 7.63

Test

Suspension

(N and N0):

N Vc1 Vc2 X̄ wm =

10-746 39 7.17 ≤ LgN0 ≤ 7.70?

>6.42 5 MINUTES

10% >300 >300 >3000 >3.18 <4.24 5 MINUTES

NEAT 0 0 <10 <1

Yes

ProductVc1 Vc2 Na = X̄ x 10 Log Na Log R Contact time

Conc.

Lowest effective concentration NEAT

LAB Number: 622196 10 of 10 Vital Oxide