TEST REPORT N. 20/000279386Pag. 1 di 8 Report digitally signed in accordance with Legislative...

TEST REPORT N. 20/000279386Date of issue date of issue 22/07/2020

Messrs Customer ID 0067590 Aintech SpA

EXEQUIEL FERNANDEZ3397 MACUL SANTIAGOCile

Sample information

Acceptance number 20.512775.0002

Delivered by DHL International on 24/04/2020

Receiving Date 24/04/2020

Place of origin Aintech SpA EXEQUIEL FERNANDEZ 3397 MACUL SANTIAGO Cile

Sample Description AIRCOP Alcoholic Disinfection for human hygiene (PT01, PT02) with copper powder AIR141428

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

VIRUCIDAL ACTIVITY:SUSPENSION TEST view attached 06/05/2020 09 2Met.: UNI EN 14476:2019 report 22/07/2020

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 CileDescription: AIRCOP Alcoholic Disinfection for human hygiene (PT01, PT02) with copper powder AIR141428

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

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.

follow test report n. 20/000279386

If not otherwise specified, the uncertainty is extended and has been calculated with a coverage factor k=2 corresponding to a probability interval of about 95%. LoD is the detection limit andidentifies a confidence interval of zero with a probabilty interval of about 99%. LoQ is the limit of quantification."n.d" is not detected and indicates a value inferior to the LoD. "traces (X)" meansa value between LoD and LoQ, this value is indicative. "<x" or ">x" indicate inferior or superior to the measurement field of the test. If not differently specified, the sums are calculated by lowerbound criteria (L.B.). In case of alteration of the sample the laboratory declines any responsibility on the results that can be influenced by the deviation in case the customer asks for theexecution of the test anyway. If the sampling is not carried out by the laboratory staff, the results obtained are considered referring to the sample as received and the laboratory declines itsresponsibility for the results calculated considering the sampling data provided by the Customer. The name and contact information of the Customer are always provided by the Customer. Ifnot differently specified the quantitative microbiological tests (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.

Pag. 1 di 8

Report digitally signed in accordance with Legislative Decrete No.82 of March, the 7th, 2005 and s.m.i

The test results contained in this Test Report refer only to the analyzed sample. This 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 e-mail [email protected] web site merieuxnutrisciences.com/eu

VAT n. IT 01500900269 R.E.A Treviso 156079 fully paid up € 103.480,00

Mod. 989/SQ rev.6 EN

ATTACHMENT TO TEST REPORT 20/000279386

UNI EN 14476+A2:2019

Chemical disinfectants and antiseptics

Quantitative suspension test for the evaluation

of virucidal activity in the medical area

(phase 2, step 1)

ID Sample: 20.512775.0002

Sample description: AIRCOP Alcoholic Disinfection for human hygiene (PT01, PT02) with copper

powder - AIR141428

Manufacturing date: n.a.

Expiry date: n.a.

Receiving date: 06/05/2020

Storage conditions: RT, darkness

Product appearance: liquid and colorless

Active substances: Isopropanol and Copper powder

Sponsor Aintech SPA

EXEQUIEL FERNANDEZ

3397 SANTIAGO, MACUL

Chile

METHOD

UNI EN 14476+A2:2019

Follow test report n. 20/000279386

Pag. 2 di 8





Mod. 989/SQ rev. 6 EN

EXPERIMENTAL CONDITIONS

- Test virus and number of passages:

Vaccinia virus, strain Ankara, ATCC-VR-1508 (passage n° 5)

Adenovirus type 5, strain Adenoid, 75 ATCC VR-5 (passage n° 4)

Poliovirus type 1 LSc-2ab, Eurovir Hygiene Institut (passage n° 4)

- Cell line and number of passages:

BHK-21-cl 13, IZS-Brescia for the propagation of Vaccinia virus (passage n° 93+6)

HeLa, ATCC CCL.2 for the propagation of Adenovirus type 5 (passage n° 38+4)

LLC-MK2 ATCC CCL-7.1 for the propagation of Poliovirus (passage n° 53 + 4)

- Product test concentrations: 75%, 25%, 5%

- Diluents used for product test solutions: Hard water

- Appearance of product dilutions: Liquid and colorless

- Stability and appearance of the mixture during the procedure: Stable, without precipitates

- Interfering substance: Albumin Bovine 0,3 g/l (clean condition)

- Contact times: 60 min 10 sec

- Test temperature: 25 °C 1°C

- Neutralization method: Dilution in ice-cold medium

- Growth medium: MEM 10% FCS

- Maintenance medium: MEM 2% FCS

- Cells incubation conditions: 37 °C, 5 % CO2

- Testing period: 28/05/2020 - 01/07/2020

TEST RESULTS

See tables n° 1 to 6.

CONCLUSIONS

According to UNI EN 14476+A2:2019, under the test conditions applied, the test product at concentration 75% resulted

to have virucidal activity (R ≥ 4) against Adenovirus and Vacciniavirus. Instead the test product at the concentrations

25% and 5% not have virucidal activity (R < 4) against Adenovirus and Vacciniavirus. Furthermore, test product at

concentrations 75%, 25% and 5% resulted not to have virucidal activity (R < 4) against Poliovirus.


Pag. 3 di 8






Table 1: Results of the test UNI EN 14476+A2:2019 on Adenovirus

Adenovirus

Test Contact

time Interfering substance

Concentration Virus titration (Log TCID50)

Reduction Acceptance

criteria Result

Susceptibility (Control)

60 min PBS / 6,875

(CI95% = 0,366 → PASS) / / /

Susceptibility (Test substance)

60 min PBS 0,75%* 7,125

(CI95% = 0,366 → PASS) 0,25

(CI95% = 0,518) R < 1 PASS

Virus Titration

0 min 0,3 g/l bovine

albumin /

6,875 (CI95% = 0,366 → PASS)

/ / /


albumin /

7 (CI95% = 0,378 → PASS)

0,125 (CI95% = 0,526)

R < 1 PASS

Reference Virus Inactivation

30 min / 0,7% 3,375

(CI95% = 0,25 → PASS) 3,625

(CI95% = 0,627) 3 ≤ R ≤ 5 PASS

60 min / 0,7% 2,875

(CI95% = 0,366 → PASS) 4,125

(CI95% = 0,824) 3,5 ≤ R ≤ 5,5 PASS

Virucidal Activity 60 min 0,3 g/l bovine

albumin

75% ≤ 1,5

(CI95% = 0 → PASS) ≥ 5,5

(CI95% = 0,378) ACTIVE if

R ≥ 4 ACTIVE

25% 5,625

(CI95% = 0,412 → PASS) 1,375


R ≥ 4 NOT ACTIVE

5% 6

(CI95% = 0,378 → PASS) 1


R ≥ 4 NOT ACTIVE

Efficency of Product's Activity Suppression


albumin

75% 7,125

(CI95% = 0,366 → PASS) 0,125

(CI95% = 0,526) R ≤ 0,5 PASS

25% 6,75

(CI95% = 0,328 → PASS) 0,25

(CI95% = 0,5) R ≤ 0,5 PASS

5% 6,875

(CI95% = 0,366 → PASS) 0,125

(CI95% = 0,526) R ≤ 0,5 PASS

* lowest apparently non cytotoxic dilution


Pag. 4 di 8






Table 2: Results of the test UNI EN 14476+A2:2019 on Adenovirus

Adenovirus

Test Contact


Concentration

Virus dilution (Log10)

-1 -2 -3 -4 -5 -6 -7 -8 -9 -10 -11


60 min PBS / 4444 4444

4444 4444

4444 4444

4444 4444

4444 4444

4444 4444

4440 0000

0000 0000

0000 0000

0000 0000

/


60 min PBS 0,75% 4444 4444

4444 4444

4444 4444

4444 4444

4444 4444

4444 4444

4400 4044

0000 0000

0000 0000

0000 0000

/

Virus Titration 0 min 0,3 g/l bovine

albumin / /

4444 4444

4444 4444

4444 4444

4444 4444

4444 4444

4000 4400

0000 0000

0000 0000

0000 0000

0000 0000


albumin / /

4444 4444

4444 4444

4444 4444

4444 4444

4444 4444

4444 0000

0000 0000

0000 0000

0000 0000

0000 0000


30 min PBS 0,7% / 4444 4444

4444 4440

0000 0000

0000 0000

0000 0000

0000 0000

0000 0000

0000 0000

0000 0000

0000 0000


60 min PBS 0,7% / 4444 4444

4440 0000

0000 0000

0000 0000

0000 0000

0000 0000

0000 0000

0000 0000

0000 0000

0000 0000


albumin

75% / 0000 0000

0000 0000

0000 0000

0000 0000

0000 0000

0000 0000

0000 0000

0000 0000

0000 0000

0000 0000

25% / 4444 4444

4444 4444

4444 4444

4444 4440

0004 4000

0000 0000

0000 0000

0000 0000

0000 0000

0000 0000

5% / 4444 4444

4444 4444

4444 4444

4444 4444

4440 4000

0000 0000

0000 0000

0000 0000

0000 0000

0000 0000



albumin

75% 4444 4444

4444 4444

4444 4444

4444 4444

4444 4444

4444 4444

4400 4440

0000 0000

0000 0000

0000 0000

/

25% 4444 4444

4444 4444

4444 4444

4444 4444

4444 4444

4444 4444

0440 0000

0000 0000

0000 0000

0000 0000

/

5% 4444 4444

4444 4444

4444 4444

4444 4444

4444 4444

4444 4444

0000 0444

0000 0000

0000 0000

0000 0000

/

1 to 4 = virus detectable / 0 = no virus


Pag. 5 di 8






Table 3: Results of the test UNI EN 14476+A2:2019 on Poliovirus

Poliovirus

Test Contact




criteria Result


60 min PBS / 7,125

(CI95% = 0,366 → PASS) / / /


60 min PBS 0,75%* 7

(CI95% = 0,378 → PASS) 0,125

(CI95% = 0,526) R < 1 PASS

Virus Titration


albumin /

7 (CI95% = 0,378 → PASS)

/ / /


albumin /

7,25 (CI95% = 0,444 → PASS)

0,25 (CI95% = 0,583)

R < 1 PASS


30 min / 0,7% 5

(CI95% = 0,378 → PASS) 2,25

(CI95% = 0,877) 0,5 ≤ R ≤ 2,5 PASS

60 min / 0,7% 3,5

(CI95% = 0,354 → PASS) 3,75

(CI95% = 0,836) 2 ≤ R ≤ 4,5 PASS


albumin

75% 6,75

(CI95% = 0,328 → PASS) 0,5


R ≥ 4 NOT ACTIVE

25% 7

(CI95% = 0,378 → PASS) 0,25


R ≥ 4 NOT ACTIVE

5% 6,625

(CI95% = 0,25 → PASS) 0,625


R ≥ 4 NOT ACTIVE



albumin

75% 7

(CI95% = 0,378 → PASS) 0,25

(CI95% = 0,583) R ≤ 0,5 PASS

25% 7,25

(CI95% = 0,444 → PASS) 0

(CI95% = 0,628) R ≤ 0,5 PASS

5% 7

(CI95% = 0,378 → PASS) 0,25

(CI95% = 0,583) R ≤ 0,5 PASS



Pag. 6 di 8






Table 4: Results of the test UNI EN 14476+A2:2019 on Poliovirus

Poliovirus

Test Contact


Concentration


-1 -2 -3 -4 -5 -6 -7 -8 -9 -10 -11


60 min PBS / 4444 4444

4444 4444

4444 4444

4444 4444

4444 4444

4444 4444

0404 4440

0000 0000

0000 0000

0000 0000

/


60 min PBS 0,75% 4444 4444

4444 4444

4444 4444

4444 4444

4444 4444

4444 4444

4004 0044

0000 0000

0000 0000

0000 0000

/


albumin / /

4444 4444

4444 4444

4444 4444

4444 4444

4444 4444

4440 4000

0000 0000

0000 0000

0000 0000

0000 0000


albumin / /

4444 4444

4444 4444

4444 4444

4444 4444

4444 4444

4044 0440

4000 0000

0000 0000

0000 0000

0000 0000


30 min PBS 0,7% / 4444 4444

4444 4444

4444 4444

4044 0004

0000 0000

0000 0000

0000 0000

0000 0000

0000 0000

0000 0000


60 min PBS 0,7% / 4444 4444

4444 4400

4000 0000

0000 0000

0000 0000

0000 0000

0000 0000

0000 0000

0000 0000

0000 0000


albumin

75% / 4444 4444

4444 4444

4444 4444

4444 4444

4444 4444

0440 0000

0000 0000

0000 0000

0000 0000

0000 0000

25% / 4444 4444

4444 4444

4444 4444

4444 4444

4444 4444

4444 0000

0000 0000

0000 0000

0000 0000

0000 0000

5% / 4444 4444

4444 4444

4444 4444

4444 4444

4444 4444

0400 0000

0000 0000

0000 0000

0000 0000

0000 0000



albumin

75% 4444 4444

4444 4444

4444 4444

4444 4444

4444 4444

4444 4444

0044 0440

0000 0000

0000 0000

0000 0000

/

25% 4444 4444

4444 4444

4444 4444

4444 4444

4444 4444

4444 4444

4004 0444

0040 0000

0000 0000

0000 0000

/

5% 4444 4444

4444 4444

4444 4444

4444 4444

4444 4444

4444 4444

0444 4000

0000 0000

0000 0000

0000 0000

/



Pag. 7 di 8






Table 5: Results of the test UNI EN 14476+A2:2019 on Vacciniavirus

Vacciniavirus

Test Contact




criteria Result


60 min PBS / 6,125

(CI95% = 0,366 → PASS) / / /


60 min PBS 0,75 %* 6

(CI95% = 0,378 → PASS) 0,125

(CI95% = 0,526) R < 1 PASS

Virus Titration


albumin /

6,125 (CI95% = 0,366 → PASS)

/ / /


albumin /

6,25 (CI95% = 0,328 → PASS)

0,125 (CI95% = 0,491)

R < 1 PASS


5 min / 0,7% 4,125

(CI95% = 0,366 → PASS) 2,125

(CI95% = 0,802) 0,75 ≤ R ≤ 3,5 PASS

15 min / 0,7% 3,25

(CI95% = 0,328 → PASS) 3

(CI95% = 0,733) 2 ≤ R ≤ 4 PASS


albumin

75% ≤ 1,5

(CI95% = 0 → PASS) ≥ 4,75


R ≥ 4 ACTIVE

25% 4,75

(CI95% = 0,328 → PASS) 1,5


R ≥ 4 NOT ACTIVE

5% 5

(CI95% = 0,378 → PASS) 1,25


R ≥ 4 NOT ACTIVE



albumin

75% 5,875

(CI95% = 0,366 → PASS) 0,375

(CI95% = 0,491) R ≤ 0,5 PASS

25% 6,125

(CI95% = 0,366 → PASS) 0,125

(CI95% = 0,491) R ≤ 0,5 PASS

5% 6,125

(CI95% = 0,366 → PASS) 0,125

(CI95% = 0,491) R ≤ 0,5 PASS



Pag. 8 di 8






Table 6: Results of the test UNI EN 14476+A2:2019 on Vacciniavirus

Vacciniavirus

Test Contact


Concentration


-1 -2 -3 -4 -5 -6 -7 -8 -9 -10 -11


60 min PBS / 4444 4444

4444 4444

4444 4444

4444 4444

4444 4444

4444 0040

0000 0000

0000 0000

0000 0000

0000 0000

/


60 min PBS 0,75 % 4444 4444

4444 4444

4444 4444

4444 4444

4444 4444

4004 4400

0000 0000

0000 0000

0000 0000

0000 0000

/


albumin / /

4444 4444

4444 4444

4444 4444

4444 4444

4044 4400

0000 0000

0000 0000

0000 0000

0000 0000

0000 0000


albumin / /

4444 4444

4444 4444

4444 4444

4444 4444

4044 0444

0000 0000

0000 0000

0000 0000

0000 0000

0000 0000


5 min PBS 0,7% / 4444 4444

4444 4444

4440 0044

0000 0000

0000 0000

0000 0000

0000 0000

0000 0000

0000 0000

0000 0000


15 min PBS 0,7% / 4444 4444

4044 0444

0000 0000

0000 0000

0000 0000

0000 0000

0000 0000

0000 0000

0000 0000

0000 0000


albumin

75% / 0000 0000

0000 0000

0000 0000

0000 0000

0000 0000

0000 0000

0000 0000

0000 0000

0000 0000

0000 0000

25% / 4444 4444

4444 4444

4444 4444

0440 0000

0000 0000

0000 0000

0000 0000

0000 0000

0000 0000

0000 0000

5% / 4444 4444

4444 4444

4444 4444

4000 0444

0000 0000

0000 0000

0000 0000

0000 0000

0000 0000

0000 0000



albumin

75% 4444 4444

4444 4444

4444 4444

4444 4444

4444 4444

0040 4004

0000 0000

0000 0000

0000 0000

0000 0000

/

25% 4444 4444

4444 4444

4444 4444

4444 4444

4444 4444

4440 0044

0000 0000

0000 0000

0000 0000

0000 0000

/

5% 4444 4444

4444 4444

4444 4444

4444 4444

4444 4444

0040 4444

0000 0000

0000 0000

0000 0000

0000 0000

/


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