test report n. 20/000294983...surface test of bactericidal activity view attached 15/07/2020-09 3...

LAB N° 0051 L

TEST REPORT N. 20/000294983Date of issue date of issue 31/07/2020

Messrs Customer ID 0067590 Aintech SpA

EXEQUIEL FERNANDEZ3397 MACUL SANTIAGOCile

Sample information

Acceptance number 20.521830.0001

Delivered by The Courier on 13/07/2020

Receiving Date 13/07/2020

Place of origin Aintech SpA EXEQUIEL FERNANDEZ 3397 MACUL SANTIAGO Cile 6710 BD EDE NL

Sample Description DECUTEC Surface disinfection (PT02) with copper powder DEC141408

Sampling information

Sampled by Customer

ANALYTICAL RESULTSValue/ Uncertainty Unit of measure LoQ LoD Start/end

date ofanalysis

Op.units

Line

ON SAMPLE AS IT IS 1

BACTERICIDAL ACTIVITY IN PRESENCE OF INTERFERING view attached 15/07/2020 09 2SUBSTANCES report 31/07/2020

Met.: BS EN 1276:2019

SURFACE TEST OF BACTERICIDAL ACTIVITY view attached 15/07/2020 09 3Met.: BS EN 13697:2015A1:2019 report 31/07/2020

Operative units

Unit 09 : Via Fratta Resana PHARMA (TV)

Information provided by the client

Sampled by: CustomerPick Address: Aintech SpA EXEQUIEL FERNANDEZ 3397 MACUL SANTIAGO Cile 6710 BD EDE NLDescription: DECUTEC Surface disinfection (PT02) with copper powder DEC141408

Template 756/SQ rev. 7 of 2

Report digitally signed in accordance with Legislative Decree No.82 of March, the 7th, 2005 and s.m.iThe results contained in this Test Report refer only to the analyzed sample. The test report shall not be reproduced except in full, without written approval of Chelab

laboratory.CHELAB S.r.l. Socio Unico, Company subject to the direction and coordination of Mérieux NutriSciences Corporation

Head office: Via Fratta 25 31023 Resana, Italy Phone. + 39 0423.7177 / Fax + 39 0423.715058 www.merieuxnutrisciences.itVAT nr. 01500900269, R.E.A Treviso n. 156079 Fully paid up € 103.480,00.

LAB N° 0051 L

follow test report n. 20/000294983

Biologist responsible

Dott.ssa Federica CattapanOrdine nazionale dei biologi

Albo professionale n.045961 sez.A

Num. certificato 18128093 emesso dall'entecertificatore ArubaPEC S.p.A. NG CA 3, ArubaPEC

S.p.A., IT





S.p.A., IT





S.p.A., IT

The line marked by a star (*) is not accredited by Accredia, member of MLA. If not otherwise specified, the uncertainty is extended and has been calculated with a coverage factork=2 corresponding to a probability interval of about 95%. LoD is the detection limit and identifies a confidence interval of zero with a probabilty interval of about 99%. LoQ is the limitof quantification."n.d" is not detected and indicates a value inferior to the LoD. "traces (X)" means a value between LoD and LoQ, this value is indicative. "<x" or ">x" indicate inferior orsuperior to the measurement field of the test. If not differently specified, the sums are calculated by lower bound criteria (L.B.). In case of alteration of the sample the laboratorydeclines any responsibility on the results that can be influenced by the deviation in case the customer asks for the execution of the test anyway. If the sampling is not carried out by thelaboratory staff, the results obtained are considered referring to the sample as received and the laboratory declines its responsibility for the results calculated considering the samplingdata provided by the Customer. The name and contact information of the Customer are always provided by the Customer. If not differently specified the quantitative microbiologicaltests (excluded MPN) are performed on single repetition and two consecutive dilutions in accordance to ISO 7218:2007/Amd1:2013.

Template 756/SQ rev. 7 of 2END OF TEST REPORT

Report digitally signed in accordance with Legislative Decree No.82 of March, the 7th, 2005 and s.m.iThe results contained in this Test Report refer only to the analyzed sample. The test report shall not be reproduced except in full, without written approval of Chelab

laboratory.CHELAB S.r.l. Socio Unico, Company subject to the direction and coordination of Mérieux NutriSciences Corporation

Head office: Via Fratta 25 31023 Resana, Italy Phone. + 39 0423.7177 / Fax + 39 0423.715058 www.merieuxnutrisciences.itVAT nr. 01500900269, R.E.A Treviso n. 156079 Fully paid up € 103.480,00.

Attachment to Test Report 20/000294983

The test results contained in this Test Report refer only to the analyzed sample. This test report can not be copied, even partially, without Chelab’s written permission.

Chelab S.r.l - Socio Unico

Company subject to the direction and coordination of Mérieux NutriSciences Corporation Head office: Via Fratta 25, 31023 Resana, Italy. Phone. + 39 0423.7177 / Fax + 39 0423.715058 www.merieuxnutrisciences.it

VAT nr. 01500900269, R.E.A Treviso n. 156079 Fully paid up € 103.480,00.

Page 1 of 5

Mod.2178 SQ/rev 0

Laboratory

CHELAB SRL MÉRIEUX NUTRISCIENCES

25, VIA FRATTA

31023 RESANA

ITALY

Client

Aintech SpA

EXEQUIEL FERNANDEZ

3397 MACUL - SANTIAGO

Cile

DECUTEC SURFACE DISINFECTION (PT02) WITH

COPPER POWDER - DEC141408

Evaluation of bactericidal activity according to BS EN 1276:2019

Prepared by: Irene Masetto

Date: 23/07/2020

mailto:[email protected]

http://www.merieuxnutrisciences.it/






Page 2 of 5

Mod.2178 SQ/rev 0

1. Reference Standard:

BS EN 1276:2019

Chemical disinfectants and antiseptics – Quantitative suspension test for the evaluation of

bactericidal activity of chemical disinfectants and antiseptics used in food, industrial,

domestic and institutional areas – Test method and requirements

(phase 2, step 1)

2. Sample Identification:

Product name DECUTEC Surface disinfection (PT02) with copper powder -

DEC141408

Batch number n.a.

Manufacturing date n.a.

Expiry date n.a.

Laboratory number 20.521830.0001

Receiving date 06/05/2020

Storage conditions RT, darkness

Product appearance Liquid, opaque, brown

Active substances n.a.








Page 3 of 5

Mod.2178 SQ/rev 0

3. Evaluation of bactericidal activity according to UNI EN 1276:2019

3.1 Test Method: Dilution Neutralization

3.2 Product test concentrations

dilution preparation appearance

75% solution 93.75% (v/v) in hard water liquid, traslucent, brownish

25% solution 31,25% (v/v) in hard water liquid, traslucent, brownish

5% solution 6.25% (v/v) in hard water liquid, traslucent, brownish

3.3 Test conditions

Test strains (standard) Enterococcus hirae ATCC 10541

Contact time 60 min ± 10 sec (standard)

Test temperature 25 °C ± 1 °C (standard)

Interfering substance Bovine albumin 0.3 g/l (clean conditions)

Incubation conditions 36 °C ± 1 °C for 24-48 hours

3.4 Materials and reagents

Diluent Peptone Saline Diluent

Incubation medium Tryptone Soy Agar

Rinsing liquid Polysorbate 80

Diluent

0.5 g/l

Neutralizer Lecithin

Polysorbate 80

L-Histidine

Sodium Thiosulfate

Saponin

Phosphate Buffer

Water

3 g/l

30 g/l

1 g/l

5 g/l

30 g/l

10 ml/l

3.5 Remarks

Test mixture appearance homogeneous, no precipitate

All controls and validations were within the basic limits

3.6 Results: see tables 1-2

3.7 Testing period: 17/07/2020 – 23/07/2020








Page 4 of 5

Mod.2178 SQ/rev 0

4. Conclusions

According to BS EN 1276:2019, the test product DECUTEC Surface disinfection (PT02) with

copper powder - DEC141408 has activity (log R ≥ 5) against Enterococcus hirae ATCC 10541

for general purposes when used at concentration

- 75% (v/v)

- 25% (v/v)

- 5% (v/v)

under the following test conditions

Contact time: 60 min 10 sec (standard)

Temperature: 25 °C 1 °C (standard)

Interfering substance: Bovine albumin 0.3 g/l (clean conditions)

Test strains: Enterococcus hirae ATCC 10541








Page 5 of 5

Mod.2178 SQ/rev 0

Table 1: Validation procedure BS EN 1276:2019

VC NV

NV0 A B C

= viable count = number of cfu/ml in the validation suspension = number of cfu/ml in the validation/control mixtures at the beginning of the contact time = number of cfu/ml in the experimental conditions control at the end of the contact time = number of cfu/ml in the filtration control at the end of the contact time = number of cfu/ml in the method validation at the end of the contact time Requirements: 30 ≤ NV0 ≤ 160; A, B, C ≥ 0.5 NV0

Table 2: Test procedure BS EN 1276:2019

VC N N0 Na R

= viable count = number of cfu/ml in the test suspension = number of cfu/ml in the test mixture at the beginning of the contact time = number of cfu/ml in the test mixture at the end of the contact time = reduction in viability ( log R = log N0 – log Na ) Requirement: 7.17 ≤ log N0 ≤ 7.70 ACTIVE if log R ≥ 5

10-1: Vc: Vc: Vc:

NV: 4,65 × 10 2 A: B: C:

NV0: 46,5PASS

Enterococcus hirae58 - 35 36 - 40 46 - 48 42 - 36

38 47 39

ATCC 10541 PASS PASS

Test OrganismsValidation

Suspension Experimental

Conditions Control

A

Neutralizer/Filtration

Control

B

Method Validation

C

Validation Test - Sample nr. 20.521830.0001

Contact time: 60 min ± 10 sec (additional)

10-6: 10 0 : 10 0 : 10 0 :

10-7: < 1,40 x 10 2 < 1,40 x 10 2 < 1,40 x 10 2

N: 1,65 × 10 8 < < <

N0: 1,65 × 10 7 > 5,07 > 5,07 > 5,07

log N0: 7,22

Test Procedure - Sample nr. 20.521830.0001

0 - 0

2,15

log R

2,15

log RATCC 10541

log R

ACTIVE ACTIVE ACTIVE

Na

log Na

Na NaEnterococcus hirae

16 - 17

162 - 167

Test Organisms Test Suspension

75% 25% 5%

2,15

0 - 0 0 - 0

log Na log Na








Page 1 of 5

Laboratory

CHELAB SRL MÉRIEUX NUTRISCIENCES

25, VIA FRATTA

31023 RESANA

ITALY

Client

Aintech SpA

EXEQUIEL FERNANDEZ

3397 MACUL - SANTIAGO

Cile

DECUTEC SURFACE DISINFECTION (PT02) WITH

COPPER POWDER - DEC141408

Evaluation of bactericidal activity according to BS EN 13697:2015 + A1:2019

Prepared by: Lelia Vecchio

Date: 21/07/2020








Page 2 of 5

1. Reference Standard:

BS EN 13697:2015 + A1:2019

Chemical disinfectants and antiseptics – Quantitative non-porous surface test for the

evaluation of bactericidal and/or fungicidal activity of chemical disinfectants used in the

food, industrial, domestic and institutional area – Test method and requirements

(phase 2, step 2)

2. Sample Identification:

Product name DECUTEC Surface disinfection (PT02) with copper powder -

DEC141408

Batch number n.a.

Manufacturing date n.a.

Expiry date n.a.

Laboratory number 20.521830.0001

Receiving date 06/05/2020

Storage conditions RT, darkness

Product appearance Liquid, opaque, brown

Active substances n.a.








Page 3 of 5

3. Evaluation of bactericidal activity according to BS EN 13697:2015 + A1:2019

3.1 Test Method: Dilution Neutralization

3.2 Product test concentrations

dilution preparation appearance

50% solution 50% (v/v) in hard water liquid, traslucent, brownish



3.3 Test conditions

Test strains (standard) Enterococcus hirae ATCC 10541

Contact time 60 min ± 10 sec (standard)

Test temperature 25 °C ± 1 °C (standard)

Interfering substance Bovine albumin 0.3 g/l (clean conditions)

Incubation conditions 36 °C ± 1 °C for 24-48 hours

3.4 Materials and reagents

Diluent Peptone Saline Diluent

Incubation medium Tryptone Soy Agar

Test surface Stainless steel discs

Neutralizer Lecithin

Polysorbate 80

L-Histidine

Sodium Thiosulfate

Saponin

Phosphate Buffer

Water

3 g/l

30 g/l

1 g/l

5 g/l

30 g/l

10 ml/l

3.5 Remarks

Product on dried surface homogeneous, clear, no reaction

All controls and validations were within the basic limits

At least one concentration of the product demonstrated a R < 4

3.6 Results: see tables 1-2

3.7 Testing period: 17/07/2020 – 20/07/2020








Page 4 of 5

Conclusions

According to BS EN 13697:2015 + A1:2019, the test product DECUTEC Surface disinfection

(PT02) with copper powder - DEC141408 has activity (R ≥ 4) against Enterococcus hirae

ATCC 10541 for general purposes surface disinfection when used at concentration

- 50% (v/v)

- 25% (v/v)

- 5% (v/v)

under the following test conditions

Contact time: 60 min 10 sec (standard)

Temperature: 25 °C 1 °C (standard)

Interfering substance: Bovine albumin 0.3 g/l (clean conditions)

Test strains: Enterococcus hirae ATCC 10541








Page 5 of 5

Table 1: Validation procedure BS EN 13697:2015 + A1:2019 bactericidal

N NC NT Nc Nts

= log cfu in 0.05 ml of test suspension = log cfu per test surface in the neutralizer control = log cfu per test surface in the method validation = log cfu per test surface in the water control = number of cfu remaining on the test surface Requirements: 6.57 ≤ N ≤ 7.10; NC – Nc ≤ ± 0.3 lg; NT – Nc ≤ ± 0.3 lg; Nc shall be sufficiently high

in order to demonstrate the requested log reduction

Table 2: Test procedure BS EN 13697:2015 + A1:2019 bactericidal

Nd R Nts

= log cfu per test surface after the test procedure = reduction in viability ( R = Nc – Nd ) = number of cfu remaining on the test surface Requirement: Nts < 100 for active concentrations ACTIVE if R ≥ 4

10 -6 : 10 -3 : 10 -3 : 10 -3 :

10 -7 : 10 -4 : 10 -4 : 10 -4 :

10 -5 : 10 -5 : 10 -5 :

10 -6 : 10 -6 10 -6 :

= 6,81 = 6,69 =6,81 Nts: >330

0 - 0 0 - 0

Test Organism Test SuspensionNeutralizer

Control

Method

ValidationWater Control

286 - 294 >330 - >330 >330 - >330 >330 - >330

0 - 0

PASS PASS

NT Nc

N

Enterococcus hirae31 - 21 66 - 63 47 - 51 57 - 71

6,864 - 6 5 - 4 5 - 6

=

PASS

ATCC 10541

NC

10 0 : 10 0 : 10 0 :

10 -1 : 10 -1 : 10 -1 :

10 -2 : 10 -2 : 10 -2 :

0 0 0

50% 25% 5%

0 - 0 0 - 0 0 - 0

Test Procedure

0 - 0 0 - 0 0 - 0

< 0,1

0 - 0 0 - 0 0 - 0

Nts : Nts : Nts :

ACTIVE ACTIVE ACTIVE

R : > 6,71 Nd : < 0,1 R : > 6,71Nd : < 0,1 R : > 6,71 Nd :

ATCC 10541

Test Organism

Enterococcus hirae



test report n. 20/000294983...surface test of bactericidal activity view attached 15/07/2020-09 3...

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