Abstract
Aims: 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.
Highlights
Over the past decade, antiseptics have been increasingly used for prophylactic or therapeutic purposes, notably as a result of the continuing rise in the frequency of antibiotic resistance in the healthcare setting [1]
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
The bactericidal activity of the antiseptic solution used pure or diluted was assessed according to the European standards EN 1040 and EN 13727
Summary
Antiseptics have been increasingly used for prophylactic or therapeutic purposes, notably as a result of the continuing rise in the frequency of antibiotic resistance in the healthcare setting [1]. Many antiseptic formulations including active substances such as chlorhexidine, iodine or chlorine derivatives, or quaternary ammonium compounds (QACs), are currently available. Some mucocutaneous antiseptic agents, such as chlorhexidine or iodine derivatives, may have a broad spectrum of activity against the main bacteria, whereas others, like QACs, may kill a smaller range of disease-causing organisms depending on their membrane structure (Gram-positive or Gram-negative) [3]. The standard EN 14885 [4] describes the application of European standards to chemical disinfectants and antiseptics and indicates the recommended and/or mandatory assays for active substances and newly marketed products: basic in vitro bactericidal activity (phase 1), in vitro activity under the conditions of intended use (phase 2, step 1), in vivo activity after standardized bacterial inoculation on skin (phase 2 step 2) and in vivo activity
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