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Representativeness of EN 1040/13727 Assay Conditions for Evaluating In Vitro the Bactericidal Activity of a Chlorhexidine Digluconate and Benzalkonium Chloride Antiseptic Preparation

Salvatico, Sylvie and Feuillolay, Catherine and Jabbour, Violaine and Gouhier-Kodas, Christelle and Roques, Christine Representativeness of EN 1040/13727 Assay Conditions for Evaluating In Vitro the Bactericidal Activity of a Chlorhexidine Digluconate and Benzalkonium Chloride Antiseptic Preparation. (2018) Open Journal of Medical Microbiology, 08 (03). 56-73. ISSN 2165-3372

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Official URL: https://doi.org/10.4236/ojmm.2018.83006

Abstract

The representativeness of the mandatory bacterial strains specified in European standards for in vitro assay of the bactericidal activity of antiseptics was evaluated by testing the activity of an antiseptic combining chlorhexidine digluconate 0.2% and benzalkonium chloride 0.5% against 21 additional bacterial strains, and the positive interaction between these two biocidal agents was assessed. Methods and Results: The bactericidal activity of the antiseptic solution used pure or diluted was assessed according to the European standards EN 1040 and EN 13727. The contact time was 1 min at 20°C. Interfering substances used in the EN 13727 assay were bovine serum albumin and sheep erythrocytes, simulating “dirty” conditions, and hard water. A reduction of colony-forming units by ≥5 log10 was deemed to meet the requirements to conclude bactericidal activity. Under “basic” conditions, the bactericidal activity of the antiseptic was observed against all four mandatory strains specified in the standards as well as against nearly all the additional strains tested, including most of those with acquired antibiotic-resistance. The positive interaction between the two biocidal agents was also confirmed. Under “dirty” conditions, the bactericidal activity of the antiseptic solution was maintained against all the mandatory strains and was reduced against only four of the additional strains tested. Conclusions: With regard to the antiseptic tested and under the experimental conditions described, bactericidal activity evidenced against the mandatory strains appeared to be representative of that manifested against a wide range of the main pathogenic bacteria. Reduced bacterial activity against some of the additional strains tested (e.g. Enterobacteriaceae) was observed under “dirty” conditions. Significance and Impact of the Study: EN 13727 with some experimental adjustments represents an additional appropriate standard that needs to be considered for mucocutaneous antiseptic assessment. However, it may be worth including other specific bacterial strains to those specified in the standard, when evaluating antiseptics intended for use in certain clinical situations

Item Type:Article
HAL Id:hal-02049491
Audience (journal):International peer-reviewed journal
Uncontrolled Keywords:
Institution:French research institutions > Centre National de la Recherche Scientifique - CNRS (FRANCE)
Université de Toulouse > Institut National Polytechnique de Toulouse - INPT (FRANCE)
Other partners > Laboratoire Innotech International (FRANCE)
Université de Toulouse > Université Toulouse III - Paul Sabatier - UPS (FRANCE)
Other partners > FONdation pour le DEveloppement de la REcherche PHARmaceutique- FONDEREPHAR (FRANCE)
Other partners > Centre Hospitalier Universitaire de Toulouse - CHU Toulouse (FRANCE)
Laboratory name:
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Deposited By: Loetitia MOYA
Deposited On:26 Feb 2019 13:27

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