Hospital Infection Research Laboratory, Queen Elizabeth Hospital Birmingham, Birmingham, UK.
Deb Group Ltd, Denby, UK.
J Hosp Infect. 2018 Apr;98(4):359-364. doi: 10.1016/j.jhin.2017.09.024. Epub 2017 Sep 30.
Hand rubs containing alcohols such as isopropanol (IPA) or ethanol (EtOH) are widely used for hygienic hand disinfection, and are presented in different formats (i.e. liquid, gel or foam).
To determine if there is any difference in efficacy between these two active ingredients in the three formats. In addition, an assessment of the drying time was undertaken. Two non-commercial, 'standard' formulations were tested in each format: one containing 60% IPA, and the other containing 80% EtOH.
EN 1500 tests were performed with 20 volunteers to assess efficacy. The reference product was 2 x 3 mL of 60% IPA for 60 s, as described in EN 1500 (2013). The test products were 3 mL of liquid, gel or foam format; one full EN 1500 test was performed for each formulation (60% IPA and 80% EtOH). To assess drying time, two different volumes (1.5 and 3.0 mL) of the test formulations in liquid, gel or foam format were applied to the hands of 15 volunteers. Volunteers self-reported when their hands were dry; at the end of the test, the volunteers were asked to rate the time taken to dry on a three-point scale (too short, OK, too long).
This study found no difference in antibacterial efficacy attributable to formulation or format for the two 'standard' ABHR formulations, as assessed by EN 1500. When measured objectively, the EtOH-based formulations dried more rapidly than the IPA-based formulations, and for both formulations, gels took longer to dry than other formats. User perception of drying time broadly agreed with objective measurement.
Given that there was no difference in efficacy and only moderate difference in drying time, it is proposed that ABHR in liquid, foam or gel format may be appropriate, provided that the specific product passes the required efficacy and safety standards.
含有异丙醇(IPA)或乙醇(EtOH)等醇类的手消毒剂广泛用于卫生手消毒,并且有不同的剂型(例如液体、凝胶或泡沫)。
确定这两种活性成分在三种剂型中的杀菌效果是否存在差异。此外,还评估了干燥时间。在每种剂型中测试了两种非商业的“标准”制剂:一种含有 60%IPA,另一种含有 80%EtOH。
使用 20 名志愿者进行 EN 1500 测试以评估功效。参考产品是 2 x 3 mL 的 60%IPA,持续 60 s,如 EN 1500(2013)所述。测试产品为液体、凝胶或泡沫剂型,每个制剂均进行了完整的 EN 1500 测试(60%IPA 和 80%EtOH)。为了评估干燥时间,将两种不同体积(1.5 和 3.0 mL)的测试制剂分别涂于 15 名志愿者的手上。志愿者自我报告何时手干燥;测试结束时,志愿者被要求在三点量表上对干燥时间进行评分(太短、可以、太长)。
本研究发现,在通过 EN 1500 评估的两种“标准”ABHR 制剂中,剂型或形式均未导致抗菌功效的差异。客观测量时,基于 EtOH 的制剂比基于 IPA 的制剂干燥更快,对于两种制剂,凝胶的干燥时间都比其他剂型长。干燥时间的用户感知与客观测量基本一致。
鉴于功效没有差异,且干燥时间仅存在适度差异,因此建议液体、泡沫或凝胶剂型的 ABHR 可能适用,只要特定产品通过了所需的功效和安全标准。