Abstract
Aims: The representativeness of European standards phase 2, step 1 regarding bactericidal and yeasticidal activities was used for the comparison of two marketed antiseptic solutions, one containing chlorhexidine digluconate (0.5%) and the other combining chlorhexidine digluconate (0.25%), benzalkonium chloride (0.025%) and benzylic alcohol (4%). Methods: The bactericidal activity of the antiseptic solutions used pure or diluted was assessed according to the European standards NF EN 13727 and NF EN 13624 for the bactericidal and yeasticidal activity respectively. The contact time was 1 min at 20°C. Interfering substances used correspond to soiling conditions i.e. bovine serum albumin and sheep erythrocytes. A reduction of colony-forming units by ≥5 log10 was deemed to meet the requirements to conclude bactericidal activity and ≥4 log10 for yeasticidal activity. Results: Regarding all the mandatory strains, both solutions are bactericidal and yeasticidal even after a 40% dilution and even under “dirty” conditions. Conclusions: The present study demonstrated the efficient bactericidal and yeasticidal activity of aqueous solutions containing chlorhexidine digluconate either alone at a concentration of 0.5% (w/v) or at a concentration of 0.25% (w/v) when combined with benzalkonium chloride at 0.025% (w/v) and benzylic alcohol 4%. These results have to be considered regarding the respective formulations and potent allergy risks.
Highlights
Over the past decade, antiseptics have been increasingly used for prophylactic or therapeutic purposes, in healthcare setting [1]
The representativeness of European standards phase 2, step 1 regarding bactericidal and yeasticidal activities was used for the comparison of two marketed antiseptic solutions, one containing chlorhexidine digluconate (0.5%) and the other combining chlorhexidine digluconate (0.25%), benzalkonium chloride (0.025%) and benzylic alcohol (4%)
The bactericidal activity of the antiseptic solutions used pure or diluted was assessed according to the European standards NF EN 13727 and NF EN 13624 for the bactericidal and yeasticidal activity respectively
Summary
Antiseptics have been increasingly used for prophylactic or therapeutic purposes, in healthcare setting [1]. There are currently various cutaneous solutions being used for antisepsis, including soaps, alcohol-based solutions, iodine-based solutions, and chlorhexidine agents [4] with the aim to control cutaneous or mucocutaneous microbial colonization resulting in a reduction of the transient or commensal flora [3]. The NF EN 13727 [17] and NF EN 13624 [18] standards are phase 2 step 1 standards required for respectively the in vitro bactericidal and yeasticidal assessment of final formulations/to-be-marketed antiseptic products with the aim of establishing the bactericidal/yeasticidal activity under simulated practical conditions appropriate to its intended use. Practical conditions correspond to dilutions and time points relevant to the actual use pattern of the final antiseptic preparation and in the presence of adapted interfering substances
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