The regulation of pesticide or antimicrobial devices that produce an antimicrobial product or act as the antimicrobial is complex, as regulation of these products in the US can fall under the FDA or EPA. Successfully navigate regulatory requirements and registration of these products with im体育APP’s consultative regulatory and scientific experts.
Examples of these types of devices include, 但不限于, 紫外线(UV), 消毒, 蒸汽, 臭氧, 红外, 还有电离装置. 抗菌 Pesticide Devices that work by physical means are regulated by the United States 环境 Protection Agency (EPA) and do not require registration. EPA农药法规 do require pesticide device producers to generate efficacy data in support of all claims. 例如, UV lights are considered to be an antimicrobial pesticide device, as the antimicrobial is generated and used on site.
For more than three decades, we have served as the premier partner to the industry. We have experience and expertise developing custom protocols and testing to numerous established methods. The most frequently asked for methodology has been listed here, so if you do not see the method you are interested in, 与我们联系.
蒸汽清洗装置试验
Virucidal Efficacy of a Steam Cleaning Device for Use on Inanimate 环境 Surfaces – When devices are tested using this method, an aliquot of virus is dried on a carrier surface (2” x 2” ceramic tiles) then exposed to the 蒸汽 device for the specified exposure time(s) or recommended method of application. 曝光后 or application, the virucidal and cytotoxic activities are removed from the virus-test substance mixture, and the mixture is assayed for viral infectivity by an accepted assay method. Appropriate virus, test substance cytotoxicity, and neutralization controls are run concurrently.
通常, for a device to be considered efficacious, least a 3 log reduction of the virus should be demonstrated.
紫外线装置测试
Evaluation of the Virucidal Activity of a UV Device for Use on Inanimate 环境 Surfaces - When 紫外线设备 are tested to this method, a film of virus dried on a glass surface (or other hard, non-porous surface) is exposed to the UV test device for the Sponsor specified exposure time, 距离, 和波长. 曝光后, the carriers are neutralized and assayed viral infectivity by an accepted assay method. Appropriate virus and cytotoxicity controls are run concurrently.
通常, for a device to be considered efficacious, least a 3 log reduction of the virus should be demonstrated.
Custom pesticide/antimicrobial device testing
In addition to testing antimicrobial pesticide devices to established methods, our team can work with you to develop custom protocols tailored to meet your specific device testing needs. We have worked with many devices including, but not limited to the following:
- 紫外线设备
- 蒸汽清洗/拖地装置
- 臭氧设备
- 红外光装置
- 离子发生器
- 消毒液产生装置
im体育APP优势
The regulations governing antimicrobial pesticide devices is complicated. With more than thirty years of experience supporting the successful registration of a multitude of products, our responsive teams can help you to determine how to generate needed data to comply with regulatory requirements for your antimicrobial pesticide device. Partner with im体育APP for testing to established methods, as well as for customized protocols tailored to meet your specific needs. We can partner with you to develop protocols that can be presented to regulatory agencies for approval in advance of testing to help ensure data acceptance.
For more information about im体育APP’s virucidal antimicrobial pesticide device testing services or methods not listed on this page, im体育APP 今天.
来自im体育APP的更多信息
微生物学检验
im体育APP offers a diverse array of microbiology testing services and can serve clients from early-stage antimicrobial product development and non-GLP screen testing all the way through GLP testing for submission.
病毒学检测
im体育APP offers GLP and cGMP virology testing options to serve our clients in the antimicrobial and pharmaceutical industries.
关于im体育APP Eagan
im体育APP Eagan is the premier contract antimicrobial testing laboratory and expert partner to the developers, manufacturers and users of antimicrobial pesticide and biocide products. We have more than 30 years of experience generating GLP-compliant data.
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