Disinfectants and sanitizers are chemicals that reduce, 摧毁, or inactivate microorganisms including bacteria, 真菌, 酵母, 和病毒. Disinfectant and sanitizing claims are regulated by the EPA in the US, and data demonstrating antiviral activity must be generated to support these claims.

这些产品在预防疾病方面起着至关重要的作用,可以通过各种方法应用于表面. These application methods can include liquids applied by mopping or soaking, trigger/pump or aerosol spray, or pre-saturated towelettes. These products can be used on hard surfaces as well as soft surfaces, and may also contain residual properties or be used in antimicrobial coatings.

For more than three decades, im体育APP has supported product formulators, 制造商, 营销人员评估消毒和消毒产品对微生物和病毒的功效. 我们的咨询监管和科学团队致力于为既定方法提供最高质量的数据. We have the experience and expertise to develop custom protocols to meet your needs. 我们的病毒学家有几十年的经验,根据既定的方法和定制的协议测试产品. If you don't see the method you are interested in, im体育APP 今天 今天 to explore alternative methods. We are confident that we can meet your specific disinfectant/sanitizer testing needs.

悬架测试

ASTM E1052 Standard Practice for Efficacy of 抗菌 Agents Against Viruses in Suspension - 这种做法 is used primarily as a screening tool to assess efficacy of a product. It may also be used for hand sanitizer type products. 用这种方法, 用试验病毒接种试验物质的等分物,并保持所需的暴露时间。. At each predetermined exposure time an aliquot is removed, neutralized by serial dilution, and assayed for viral infectivity by an assay method specific for the test virus. 适当的病毒, test substance cytotoxicity, and 中和 controls are run concurrently. 与相应的病毒控制相比,计算病毒传染性降低的百分比和对数. 通常, for a product to be considered as being efficacious, least a 1 log reduction (90.0%) of the virus should be demonstrated. For registration with US EPA against a hard surface, a product must demonstrate a 3 log reduction (99.9%) following a hard surface test method.

硬表面试验

ASTM E1053用于无生命环境表面的杀毒剂功效的标准实施规程。液体/喷雾/湿巾 - In 这个方法, 在玻璃培养皿(“载体”)中接种有代表性的试验病毒,并将病毒干燥到载体上. 接种载体暴露于测试物质(液体产品)的等量稀释物中。, 或在使用条件下释放的喷雾量(喷雾产品)或按使用说明擦拭(预饱和毛巾). The carrier is held for the requested exposure time at the requested exposure temperature. 曝光后, 将载体的内容物中和,并对中和的试验物质进行连续稀释. 然后用测试病毒特有的测定方法测定稀释后的病毒感染性. 适当的病毒, test substance cytotoxicity, and 中和 controls are run concurrently. 通常, 大多数监管机构要求病毒至少减少3倍,才能声称在坚硬的表面上有效.

无生命环境表面消毒剂的杀病毒效果。替代病毒。液体/喷雾/湿巾 - ASTM E1053 standard practice is used for testing, however two replicate carriers are required to be tested for the virus control and test lots. Surrogate viruses accepted by US EPA are:

利用鸭乙肝病毒替代人乙肝病毒清洁消毒血糖监测仪外表面消毒剂的杀病毒效果验证 -每种材料, compromising the exterior of the device, is inoculated with the test virus and the virus is dried. 按照主办方的说明,用消毒剂擦拭接种的材料,并在要求的暴露温度下保持消毒剂标签上列出的暴露时间. 曝光后, 将接种的材料单独中和,并对中和的试验物质进行连续稀释. 然后用测试病毒特有的测定方法测定稀释后的病毒感染性. 适当的病毒, test substance cytotoxicity, 中和, and negative (cell) controls are run concurrently. 美国 FDA要求 complete inactivation of the virus in all dilutions assayed.

无生命环境表面消毒剂的杀病毒效果。静电喷雾器的应用 -在玻璃培养皿(“载体”)中接种有代表性的测试病毒,并将病毒干燥到载体上. 接种载体以最小和最大距离暴露于在使用条件(喷雾产品)下释放的喷雾量. The carrier is held for the requested exposure time at the requested exposure temperature. 曝光后, 将载体的内容物中和,并对中和的试验物质进行连续稀释. 然后用测试病毒特有的测定方法测定稀释后的病毒感染性. 适当的病毒, test substance cytotoxicity, and 中和 controls are run concurrently. 一般, 大多数监管机构要求病毒至少减少3倍才能声称有效. EPA testing and regulatory submission information can be found 在这里.

软表面试验

Virucidal Efficacy of a Laundry Additive -用这种方法, a series of fabric swatches are inoculated with the test virus and are dried. 含有干燥试验病毒的样本被放置在织物包裹的纺锤内,并在模拟洗衣设备中进行处理. 治疗后, the swatches and a sample of the wash water are removed, neutralized and are assayed for viral infectivity by an assay method specific for the test virus. 适当的病毒, test substance cytotoxicity, and 中和 controls are run concurrently. 通常, 与病毒对照相比,必须证明处理过的织物样本和处理过的洗涤水的功效至少减少3倍.

Virucidal Efficacy of a Disinfectant for Use on Soft Surfaces- liquid or spray products -织物(软)表面(“载体”)接种具有代表性的测试病毒,并将病毒干燥到载体上. 接种载体暴露于测试物质(液体产品)的等量稀释物中。, or to the amount of spray released under use conditions (spray products). The carrier is held for the requested exposure time at the requested exposure temperature. 曝光后, 将载体的内容物中和,并对中和的试验物质进行连续稀释. 然后用测试病毒特有的测定方法测定稀释后的病毒感染性. 适当的病毒, test substance cytotoxicity, and 中和 controls are run concurrently. 通常, 大多数监管机构要求病毒至少减少3倍才能声称有效.

Disinfection qualification testing

Disinfection Validation/Qualification Against Viruses (USP 1072) -用这种方法, 使用赞助商设施中可能遇到的代表性表面和测试物质(消毒剂)评估使用目标病毒的消毒程序. This testing is described in the United States Pharmacopeia (USP) Chapter 1072. Minimum log reduction requirements are determined by the Sponsor.

Topical skin products testing 

Virucidal Efficacy of Topical Skin 产品s Utilizing an Ex-Vivo Skin Model -将具有代表性的试验病毒接种于皮肤基质(“载体”),并将病毒干燥到载体上. 接种载体暴露于测试物质(液体产品)的等量稀释物中。, 或在使用条件下释放的喷雾量(喷雾产品)或按使用说明擦拭(预饱和毛巾). The carrier is held for the requested exposure time at the requested exposure temperature. 曝光后, 将载体的内容物中和,并对中和的试验物质进行连续稀释. 然后用测试病毒特有的测定方法测定稀释后的病毒感染性. 适当的病毒, test substance cytotoxicity, and 中和 controls are run concurrently. Percent and log reductions are calculated based on the virus control.

另外, 可将试验物质涂于代替病毒的皮肤基质(“载体”)上并在其上干燥. 然后,将携带者暴露于等量的测试病毒中,并在要求的暴露温度下保持所需的暴露时间. 曝光后, 将载体的内容物中和,并对中和的试验物质进行连续稀释. 然后用测试病毒特有的测定方法测定稀释后的病毒感染性. 适当的病毒, test substance cytotoxicity, and 中和 controls are run concurrently. Percent and log reductions are calculated based on the virus control.

我们的团队可以与您一起开发定制协议,以满足您的消毒剂/消毒剂测试需求.

im体育APP优势 

使用im体育APP全面的消毒剂和消毒剂功效测试服务,确保消毒剂和消毒剂的杀毒功效声明符合法规要求. Partner with im体育APP for testing to established methods, as well as for customized protocols tailored to meet your specific needs. Our team stands by the data we develop, 我们将与您和监管机构合作,回答有关您的产品测试的任何问题. We are also prepared to defend the testing and the data developed if the need arises.

If you are interested in methodology not listed on this page, please reach out to us. For more information about im体育APP’s virucidal disinfectant efficacy testing services, im体育APP 今天.

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