Prestisept

SKU MJ8730PO Categories Disinfectants, Healthcare

Prestisept is a ready-to-use antiseptic soap based on 4% chlorhexidine digluconate, for hygienic and surgical hand disinfection by washing in healthcare facilities. Antiseptic hand soap

Hygienic disinfection: 5 mL, contact time 60 seconds (EN 1499)
Surgical disinfection: 2 × 5 mL, 2 × 30 seconds (EN 12791)
Bactericidal, yeasticidal and virucidal against enveloped viruses, according to the tests in the approval
Dermatologically tested: non-irritating

Packaging: 500 mL, 1 L bottle; 5 L canister

Hygienic and surgical skin disinfection

Ready to use

Bactericidal, Fungicidal, Mycobactericidal, Tuberculocidal and Virucidal.

Antiseptic soap for hygienic and surgical hand disinfection

Prestisept is a ready-to-use liquid antiseptic soap based on 4% chlorhexidine digluconate, for hygienic and surgical hand disinfection by washing in healthcare facilities.

Hygienic disinfection takes 60 seconds and surgical disinfection 2 × 30 seconds, followed by rinsing. The product is intended for professional users and the general public.

Approved by the Romanian Ministry of Health – Approval No. 3980BIO/01/12.24 (PT1), extended by approval No. 3980BIO/01/12.30 until 31.12.2030
The indication for use in healthcare facilities is valid until 06.02.2029.

Hand disinfection by washing, in healthcare facilities

Main benefits

Washes and disinfects

Hygienic handwash disinfection in 60 seconds (EN 1499).

Surgical disinfection

2 × 5 mL, 2 × 30 seconds (EN 12791), with immediate effect.

Chlorhexidine 4%

Antiseptic soap based on chlorhexidine digluconate, the type of surgical soap provided for by Romanian MoH Order 1761/2021.

Dermatologically tested

Classified as non-irritating in a skin compatibility test on 25 volunteers.

Where to use it

Field of use: human hygiene (PT1).
Area of application: hygienic and surgical hand disinfection by washing, in healthcare facilities. The approval also includes efficacy tests for use outside healthcare facilities.
Users: professionals and the general public.

Directions for use

Apply the dose of product, as supplied, to the hands, massage all hand surfaces for the full contact time, then rinse with water. After surgical disinfection, dry hands with a sterile towel.

Method 1

Hygienic hand disinfection

5 mL of product, by washing.
Contact time: 60 seconds.

Method 2

Surgical hand disinfection

2 × 5 mL of product, by washing – immediate effect.
Contact time: 2 × 30 seconds.

Method 3

With limited virucidal activity

Hygienic: 5 mL; surgical: 2 × 5 mL, undiluted (tested on Vaccinia virus).
Contact time: 2 minutes.

Tested efficacy

Disinfection in healthcare facilities

Activity	Standard and conditions	Test organisms	Concentration / dose	Contact time
Bactericidal¹	EN 1499:2013 (hygienic handwash)	Escherichia coli K12 NCTC 10538	5 mL, as supplied	60 seconds
Bactericidal¹	EN 12791:2016+A1:2017 (surgical hand disinfection)	Normal hand flora	2 × 5 mL, as supplied	2 × 30 seconds (immediate effect)
Bactericidal¹	EN 13727:2012+A2:2015 dirty conditions	Pseudomonas aeruginosa ATCC 15442 Staphylococcus aureus ATCC 6538 Enterococcus hirae ATCC 10541 Escherichia coli K12 ATCC 10538	50%	1 minute
Yeasticidal¹	EN 13624:2021 dirty conditions	Candida albicans ATCC 10231	50%	1 minute
Virucidal²	EN 14476:2013+A2:2019 dirty conditions	Vaccinia virus, Elstree strain ATCC VR-1549	50%	2 minutes

According to the EN 12791 test report, an immediate effect was demonstrated; a sustained effect was not demonstrated.
¹ Efficacy in healthcare facilities valid until 06.02.2029. ² Virucidal efficacy valid until 29.02.2029.

Other areas, outside healthcare facilities

Activity	Standard and conditions	Test organisms	Concentration / dose	Contact time
Bactericidal	EN 1499:2013	Escherichia coli K12 NCTC 10538	5 mL, 100%	30 seconds
Bactericidal	EN 13727:2012+A2:2015 dirty conditions	Pseudomonas aeruginosa ATCC 15442 Staphylococcus aureus ATCC 6538 Enterococcus hirae ATCC 10541 Escherichia coli K12 NCTC 10538	20%, 50%, 100%	1 minute; 3 minutes
Yeasticidal	EN 13624:2013 dirty conditions	Candida albicans ATCC 10231	20%, 50%, 100%	1 minute; 3 minutes
Virucidal (virus inactivation)	UNE-EN 14476:2014+A1:2015	Vaccinia virus (ATCC VR-1508)	50%, 25%, 0.01%	30 seconds

According to the test report, Prestisept is active against enveloped viruses (HIV, HCV, HBV, Herpesviridae, coronaviruses).

Skin tolerance

Prestisept was assessed in an open skin test under dermatological supervision on 25 healthy adult volunteers (J.S. Hamilton Poland, report No. 371713/19/JSHR of 21.08.2019). The mean irritation index was 0.00: no irritation or allergic reactions occurred in the tested group, and the product was classified as non-irritating. The result does not apply to people allergic to any of the ingredients.

Composition

Active substance	EC No.	CAS No.	Concentration
Chlorhexidine digluconate (D-gluconic acid, compound with N,N″-bis(4-chlorophenyl)-3,12-diimino-2,4,11,13-tetraazatetradecanediamidine (2:1))	242-354-0	18472-51-0	4%

Formulation: ready-to-use liquid.
Biocidal product type: main group 1, PT1 – human hygiene.
Labelling: no hazard pictograms or hazard statements. P102 – Keep out of reach of children. P305 + P351 + P338 – If in eyes: rinse cautiously with water for several minutes; remove contact lenses, if present and easy to do, and continue rinsing.

Available packaging

Bottles

500 mL, 1 L

For professional users

5 L canister

The approval also covers 100 mL and 300 mL bottles. Contact us for other formats.

Use biocides safely. Always read the label and product information before use.

Documents and useful information

Ministry of Health Approval No. 3980BIO/01/12.24 – PT1 (PDF, in Romanian)
Extension approval No. 3980BIO/01/12.30 (PDF), valid until 31.12.2030
Dermatological test report (PDF, Romanian translation)
Prestisept safety data sheet (PDF)
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