Product Information FIX & DES bulk 7.5
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CARELA ®<br />
ensures hygienic conditions!<br />
<strong>Product</strong> <strong>Information</strong><br />
<strong>FIX</strong> & <strong>DES</strong> <strong>bulk</strong> <strong>7.5</strong><br />
Powerful<br />
Disinfectant<br />
Non-alcoholic and<br />
ready-to-use<br />
www.carela-group.com
2/14 CARELA®<br />
CARELA®<br />
3/14<br />
<strong>FIX</strong> & <strong>DES</strong> <strong>bulk</strong> <strong>7.5</strong>%<br />
Areas of application include (but are not<br />
limited to) particularly strongly contaminated<br />
objects and surfaces in hospital and care<br />
sector, medical practices, human hygiene,<br />
sanitation in swimming pool facilities, hotels<br />
and restaurants, food production industry.<br />
Several expert’s reports scientifically confirmed<br />
the efficacy of <strong>FIX</strong> & <strong>DES</strong> <strong>bulk</strong> <strong>7.5</strong> for various<br />
concentrations and reaction times. Due to<br />
these excellent findings for an application as<br />
a rapid disinfection agent, <strong>FIX</strong> & <strong>DES</strong> <strong>bulk</strong> <strong>7.5</strong><br />
is delivered at a concentration of <strong>7.5</strong>% as this<br />
allows a reaction time of only about 1 minute.<br />
A reliable efficacy against Pseudomonas aeruginosa within 1 minute was successfully verified!<br />
<strong>FIX</strong> & <strong>DES</strong> <strong>bulk</strong> <strong>7.5</strong> is classified as no hazardous good (see SDS), as hazardous material according<br />
to German Gefahrstoff-Verordnung (regulation on hazardous materials) and to CLP regulation<br />
(EC) No 1272/2008, does not contain toxic ingredients.<br />
The product <strong>FIX</strong> & <strong>DES</strong> <strong>bulk</strong> <strong>7.5</strong> is most commonly and willingly used for rapid disinfection of<br />
technical components such as water meters, standpipes, fittings and sealing elements by leading<br />
municipal water suppliers and in service companies for sanitation, heating and air conditioning.<br />
If for example water meters or standpipes are disinfected for storage, disinfected components<br />
should be rinsed with drinking water before assembly to remove the product after the reaction<br />
time. This can easily be done as all active ingredients of <strong>FIX</strong> & <strong>DES</strong> <strong>bulk</strong> <strong>7.5</strong> are water soluble.<br />
<strong>FIX</strong> & <strong>DES</strong> <strong>bulk</strong> <strong>7.5</strong>% is a surface disinfection<br />
agent with extremely fast efficacy.<br />
Visit our website<br />
www.carela-group.com/disinfectant<br />
CARELA GmbH<br />
Schafmatt 5<br />
79618 Rheinfelden<br />
Tel. +49 76 23 72 24 – 0<br />
Fax +49 76 23 72 24 – 99<br />
info@carela.com<br />
www.carela-group.com<br />
Use biocides safely. Always read the label and product information before use.
4/14 CARELA®<br />
CARELA®<br />
5/14<br />
<strong>FIX</strong> & <strong>DES</strong> <strong>bulk</strong> <strong>7.5</strong> eliminates 99,9% of bacteria<br />
ü<br />
ü<br />
ü<br />
ü<br />
non-alcoholic<br />
fast-acting<br />
odourless<br />
non-hazardous<br />
ALCOHOL<br />
0%<br />
F R E E<br />
READY-TO-<br />
USE<br />
ü<br />
ü<br />
ü<br />
complies with EN 1499:2017 -<br />
hygienic handwash (phase 2, step 2)<br />
dermatologically tested: "excellent"<br />
clinically tested “excellent” (Dermatest seal)<br />
for children older than 2 years<br />
Use biocides safely. Always read the label and product information before use.
6/14 CARELA®<br />
CARELA®<br />
7/14<br />
PROFESSIONAL DISINFECTION<br />
OF ALL TYPES OF SURFACES IN<br />
SEVERAL APPLICATION FIELDS<br />
ü<br />
ü<br />
halal certified<br />
IHO and VAH listed<br />
also suitable for hands, dermatologically tested: “excellent”<br />
Use biocides safely. Always read the label and product information before use.<br />
*DEHOGA-Preise in rot ausgewiesen, zzgl. Ust. und Fracht
8/14 CARELA®<br />
ALSO AVAILABLE AS<br />
• disinfectant wipe<br />
• 1000 ml bottle<br />
• 500 ml sprayer<br />
• 100 ml foamer<br />
CARELA®<br />
CONTACTLESS<br />
HAND DISINFECTANT DISPENSER<br />
9/14<br />
CARELA ® FOAMER<br />
CARELA ® SPRAYER<br />
The contactless hand disinfectant dispensers enable the contactless application of professional disinfectants<br />
in the form of foam (FOAMER) or as a spray (SPRAYER) in commercial, public or private areas.<br />
Use biocides safely. Always read the label and product information before use.
10/14 CARELA®<br />
CARELA®<br />
11/14<br />
Benefits<br />
ü<br />
ü<br />
ü<br />
ü<br />
ü<br />
ü<br />
ü<br />
ü<br />
Disinfectant based on a blend of three different quats<br />
Supplied at neutral pH<br />
Compatible with sensitive materials such as acrylic glass, linoleum, PVC and<br />
anodised aluminium<br />
VAH<br />
IHO<br />
halal certified (HHCC/HQC)<br />
DERMATEST „Excellent“<br />
Effective against selected viruses, such as Norovirus and Vaccinia virus<br />
User <strong>Information</strong><br />
<strong>FIX</strong> & <strong>DES</strong> <strong>bulk</strong> <strong>7.5</strong> is an aldehyde-/alcohol- free, ready-to-use disinfectant with a good efficacy profile and<br />
outstanding material compatibility. <strong>FIX</strong>&<strong>DES</strong> <strong>bulk</strong> <strong>7.5</strong> (<strong>7.5</strong>% of the concentrate), is easy applicapable and<br />
perfect for use around home, bathrooms, athletic facilities and sun beds.<br />
Ingredients<br />
Blend of different quaternary ammonium approx. 0,75% ww<br />
Didecyldimethylammonium chloride (DDAC), [CAS No 7173-51-5] Alkyl (C12-16) dimethylbenzyl<br />
ammonium chloride (ADBAC/BKC (C12-16)), [CAS No 68424-85-1]Alkyl (C12-C14) dimethyl(ethylbenzyl)<br />
ammonium chloride (ADEBAC (C12-C14)), [CAS No 85409-23-0]<br />
Detailed Efficacy Data<br />
Introduction<br />
In order to support a product through the Biocidal <strong>Product</strong> Regulation (BPR, EU (No) 528/2012), relevant<br />
European test data must be submitted as part of the dossier. The EN 14885 Standard (Chemical disinfectants<br />
and antiseptics-application of European Standard for chemical disinfectants and antiseptics) specifies<br />
the laboratory methods required to substantiate the claim set for the chemical disinfectant. European<br />
Normal (EN) Test Protocols and their associated pass criteria are outlined for different application areas<br />
e.g. “medical”, “veterinary”, “food”, “industrial and institutional” and “domestic” areas.<br />
Each EN test specifies a limited range of microbial species that must be used. These have been chosen as<br />
representative organisms to substantiate broader product claims (e.g. bactericide, yeasticide, fungicide,<br />
sporicide, virucide and mycobactericide) taking into account their practical relevance for each of the application<br />
areas. In addition, different soil (or interfering substances) are specified depending on the end<br />
application. This supports the efficacy claimed by the product and its suitability for the specific area of<br />
use.<br />
All of the data presented for <strong>FIX</strong> & <strong>DES</strong> <strong>bulk</strong> <strong>7.5</strong> concentrate has been generated using standard<br />
EN Test Norms. Not all claims are valid in all registered member states.<br />
PT2 - Medical Areas<br />
Clean conditions<br />
with pre-cleaning<br />
(0.3 g/l BSA) Claim<br />
Bactericidal<br />
(non-mechanical<br />
cleaning methods)<br />
Yeasticidal<br />
(non-mechanical<br />
cleaning methods)<br />
Virucidal against<br />
Enveloped Viruses<br />
Bactericidal<br />
(Instruments)*<br />
Yeasticidal<br />
(Instruments)*<br />
Relevant<br />
EN Norm(s)<br />
EN 13697<br />
EN 13727<br />
EN 13697<br />
EN 13624<br />
Contact Time<br />
* Additional EN Test Norms relating to Instrument Disinfection<br />
2.0 % @ 15 min contact time will support claims against<br />
ü Bacteria (non-mechanical cleaning methods)<br />
ü Yeast (non-mechanical cleaning methods)<br />
ü Enveloped viruses<br />
Use<br />
Concentration<br />
Representative<br />
Organism(s)<br />
5 min 2.0 % S.aureus, E.hirae,<br />
P.aeruginosa<br />
15 min 1.5 % C.albicans<br />
EN 14476 5 min 2.0 % Modified Vaccinia<br />
Virus Ankara (MVA)<br />
EN 14561 15 min 2.0 % S.aureus, E.hirae,<br />
P.aeruginosa<br />
EN 14562 15 min 1.5 % C.albicans<br />
PT2 - Industrial and Institutional<br />
and<br />
PT4 – Food and Beverage<br />
Clean conditions<br />
with pre-cleaning<br />
(0.3 g/l BSA) Claim<br />
Bactericidal<br />
(non-mechanical<br />
cleaning methods)<br />
Yeasticidal<br />
(non-mechanical<br />
cleaning methods)<br />
Relevant<br />
EN Norm(s)<br />
EN 13697<br />
EN 1276<br />
EN 13697<br />
EN 1650<br />
Contact Time<br />
2.0 % @ 15 min contact time will support claims against<br />
ü Bacteria (non-mechanical cleaning methods)<br />
ü Yeast (non-mechanical cleaning methods)<br />
Use<br />
Concentration<br />
Representative<br />
Organism(s)<br />
5 min 2.0 % E.coli, S.aureus,<br />
E.hirae,<br />
P.aeruginosa<br />
15 min 1.5 % C.albicans<br />
Use biocides safely. Always read the label and product information before use.
12/14 CARELA®<br />
CARELA®<br />
13/14<br />
Antimicrobial Performance<br />
Food, Industrial and Institutional Areas<br />
Tested According to European Norms (EN)<br />
Activity Claim: Bactericidal<br />
EN 1276<br />
Bactericidal result (log 5), in presence of different organic loads<br />
(Albumin)<br />
Test strains: E. coli ATCC 10536, S. aureus ATCC 6538, E. hirae ATCC<br />
10541, P. aeruginosa ATCC 15442<br />
Result 1.0 % 0.3 g/l Albumin 5 min.<br />
Result 3.0 % 10.0 g/l Skimmed milk 5 min.<br />
Result 0.5 % 10.0 g/l Sucrose 5 min.<br />
Result 1.0 % 10.0 g/l Yeast extract 5 min.<br />
Certificates: Eurofins, 21 June 2011; Eurofins, 6 October 2016<br />
EN 1276<br />
Bactericidal result (log 5), in presence of low organic load (Albumin)<br />
Test strain: Listeria monocytogenes ATCC 15313 and Salmonella<br />
typhimurium ATCC 13311<br />
Result 0.5 % 0.3 g/l Albumin 5 min.<br />
Certificate: Dr. Brill & Partner GmbH, 14 February 2017<br />
EN 13697<br />
Yeasticidal result (log 3), in presence of low organic load (Albumin)<br />
Test strain: C. albicans ATCC 10231<br />
Result 1.5 % 0.3 g/l Albumin 15 min.<br />
Certificate: Eurofins, 30 September 2011<br />
Medical Areas<br />
Tested According to European Norms (EN)<br />
Activity Claim: Bactericidal<br />
EN 13727<br />
Bactericidal result (log 5), in presence of low organic load (Albumin)<br />
Test strains: S. aureus ATCC 6538, E. hirae ATCC 10541, P. aeruginosa<br />
ATCC 15442<br />
Result 1.0 % 0.3 g/l Albumin 5 min.<br />
Certificate: Eurofins, 17 June 2011<br />
EN 13697<br />
Bactericidal result (log 4), in presence of low organic load (Albumin)<br />
Test strains: E. coli ATCC 10536, S. aureus ATCC 6538, E. hirae ATCC<br />
10541, P. aeruginosa ATCC 15442<br />
Result 2.0 % 0.3 g/l Albumin 5 min.<br />
Certificate: Eurofins, 30 September 2011<br />
Activity Claim: Virucidal<br />
EN 14476<br />
Virucidal result (log 4), in presence of low organic load (Albumin)<br />
Test strain: Modified Vaccinia ankara<br />
Result 2.0 % 0.3 g/l Albumin 5 min.<br />
Certificate: Dr. Brill + Dr. Steinmann, 30 September 2015<br />
EN 14476<br />
Virucidal result (log 4), in presence of low organic load (Albumin)<br />
Test strain: Murine Norovirus strain S99 Berlin<br />
Result 4.0 % 0.3 g/l Albumin 60 min.<br />
Certificate: Hygcen, 11 November 2015<br />
Result 6.0 % 0.3 g/l Albumin 30 min.<br />
Certificate: Dr. J. Steinmann, MikroLab Bremen, 8 December 2008<br />
EN 14476<br />
Virucidal result (log 4), in presence of low organic load (Albumin)<br />
Influenza A Virus H1N1 (swine)<br />
Result 0.5 % 0.3 g/l Albumin 5 min.<br />
Certificate: Dr. Brill + Partner GmbH, 11 April 2017<br />
BVDV<br />
With soil load 0.5 % 15 min.<br />
Certificate: Dr. J. Steinmann, Bremen, 10 September 2005<br />
<strong>7.5</strong> % 1 min.<br />
After evaluation with Vaccinia virus and Bovine Viral Diarrhea<br />
virus (BVDV, surrogate of Hepatitis C virus) the surface disinfectant<br />
can be declared as having “limited virucidal” properties<br />
according to a recommendation of an expert committee of RKI<br />
(Bundesgesundheitsbl 2004, 47: 62-66) and is thus able to<br />
inactivate all enveloped viruses.<br />
Therefore, after successful experiments with the two above<br />
mentioned enveloped viruses the surface disinfectant is also<br />
effective against the so-called blood-borne viruses including<br />
HBV, HCV and HIV as well as against members of other virus<br />
families such as Orthomyxoviridae (incl. all human and animal<br />
influenza viruses like H5N1 and H1N1), Filoviridae including<br />
Ebola virus and Paramyxoviridae including Measles virus.<br />
The following concentration and exposure time are necessary for<br />
inactivation of the two test viruses:<br />
EN 13697<br />
Bactericidal result (log 4), in presence of low organic load (Albumin)<br />
Test strains: E. coli ATCC 10536, S. aureus ATCC 6538, E. hirae ATCC<br />
10541, P. aeruginosa ATCC 15442<br />
Result 2.0 % 0.3 g/l Albumin 5 min.<br />
Certificate: Eurofins, 30 September 2011<br />
EN 13697<br />
Bactericidal result (log 4), in presence of low organic load (Albumin)<br />
Test strain: Listeria monocytogenes ATCC 15313<br />
Result 1.0 % 0.3 g/l Albumin 5 min.<br />
Certificate: Dr. Brill + Partner GmbH, 14 February 2017<br />
EN 14561<br />
Bactericidal result (log 5), in presence of low organic load (Albumin)<br />
Test strains: S. aureus ATCC 6538, E. hirae ATCC 10541, P. aeruginosa<br />
ATCC 15442<br />
Result 2.0 % 0.3 g/l Albumin 15 min.<br />
Certificate: Eurofins, 28 July 2011<br />
Activity Claim: Yeasticidal<br />
EN 13624<br />
Yeasticidal result (log 4), in presence of low organic load (Albumin)<br />
Test strain: C. albicans ATCC 10231<br />
Result 0.5 % 0.3 g/l Albumin 5 min.<br />
Antimicrobial Performance<br />
Tested According to BGA (now RKI) / DVV<br />
Virucidal Performance<br />
Hepatitis-B Virus (and HIV)<br />
Results in presence of low organic load 1.5 % 30 min.<br />
Results in presence of high organic load 5.0 % 1 min.<br />
3.0 % 30 min.<br />
Statement: Dr. J. Steinmann, Mikrolab Bremen, 8 March 2015<br />
Tested According to VAH<br />
3.0 % 15 min.<br />
<strong>7.5</strong> % 1 min.<br />
(German Society for Hygiene and Microbiology), now VAH<br />
Surface Disinfection with mechanical action (Requirements and<br />
Methods for VAH Certification, 2015)<br />
P.aeruginosa, S.aureus, E.hirae and C.albicans<br />
Result 1.0 % Low organic load 5 min.<br />
Certificate: Dr. Brill + Partner, Hamburg, 3rd September 2018<br />
EN 13697<br />
Bactericidal result (log 4), in presence of low organic load (Albumin)<br />
Test strain: Salmonella typhimurium ATCC 13311<br />
Result 1.5 % 0.3 g/l Albumin 5 min.<br />
Certificate: Eurofins, 17 June 2011<br />
EN 13697<br />
Yeasticidal result (log 3), in presence of low organic load (Albumin)<br />
Test strain: C. albicans ATCC 10231<br />
1.5 % 60 min.<br />
Certificates: Prof. Dr. G. Frösner, München, 16 August 1987, 20 May 1996<br />
Rota Virus<br />
Prof. Dr. Werner, HygCen, Schwerin, 9th October 2018<br />
Certificate: Dr. Brill + Partner GmbH, 14 February 2017<br />
Result 1.5 % 0.3 g/l Albumin 15 min.<br />
Certificate: Eurofins, 30 September 2011<br />
Without soil load 0.25 % 1 min.<br />
Certificate: Dr. J. Steinmann, Bremen, 24 November 1994<br />
Activity Claim: Yeasticidal<br />
EN 1650<br />
Yeasticidal result (log 4), in presence of low organic load (Albumin)<br />
Test strain: C. albicans ATCC 10231<br />
Result 0.2 % 0.3 g/l Albumin 5 min.<br />
Certificate: Eurofins, 17 June 2011<br />
EN 14562<br />
Yeasticidal result (log 4), in presence of low organic load (Albumin)<br />
Test strain: C. albicans ATCC 10231<br />
Result 1.5 % 0.3 g/l Albumin 15 min.<br />
Certificate: Eurofins, 28 July 2011<br />
Vaccinia Virus<br />
Without soil load 1.0 % 5 min.<br />
With soil load 3.0 % 15 min.<br />
Certificate: Dr. J. Steinmann, Bremen, 25 August 2005<br />
<strong>7.5</strong> % 1 min.<br />
Use biocides safely. Always read the label and product information before use.