Microbiology Testing

Element has extensive experience performing efficacy testing to meet submission requirements for regulatory bodies worldwide, including the EPA, Health Canada, Australian Therapeutic Goods Administration (TGA), European Chemicals Agency, and the FDA.

We can partner with you to develop a testing plan with options ranging from preliminary screening to the required GLP tests for submission, and we offer a wide array of bacteria, fungi, and yeast to support your claims.

Element offers GLP microbiology testing options to serve our clients in the antimicrobial industry, including recent additions to EPA testing guidance (electrostatic spray testing, residual disinfection for 24-hour claims, residual long lasting claims for surface coatings, interim method for evaluation of bactericidal activity of copper containing surface products). Our test offerings also include biofilm testing, disinfectant efficacy testing against both C. difficile and C. auris, and residual sanitization.

We can help you with early-stage development and non-GLP screen testing all the way through GLP testing for submission. Our staff has years of experience with testing methods and regulatory agencies to deliver high quality results and superior customer service.

For more information about our antimicrobial microbiology testing services or to request a quote, contact us today.

Microbiology testing services

Disinfectants - Microorganisms including bacteria, fungi, yeast and viruses are reduced, destroyed, or inactivated by disinfectants and sanitizers. These products can be used on both soft and hard surfaces and may contain residual properties or be used in antimicrobial coatings. Element’s comprehensive disinfectant microbiology solutions include bacterial, fungicidal, tuberculocidal and sporicidal testing, as well as laundry testing, electrostatic sprayer testing, biofilm testing, MIC/MBC testing. We also have extensive experience testing antimicrobial preservatives for effectiveness.

Clostridium difficile (C. diff) and Candida auris (C. auris) testing - For registrants to make claims against C. diff or C. auris, the EPA requires registrants to quantify the ability of the Sponsor's product to produce reduction of C. diff or C. auris on hard environmental surfaces following EPA SOPs. Element has decades of experience supporting leading developers, manufacturers, and marketers of products with C. diff and C. auris disinfectant efficacy claims generate data that meets EPA disinfectant registration requirements.

Sanitizer antimicrobial testing - Sanitizers are typically categorized as either food contact or non-food contact. Element has deep expertise in testing both food contact and non-food contact sanitizers to established methodology that meets EPA published guidance for the testing and criteria required for registrants seeking claims for sanitizers.

Residual efficacy testing - Residual products can continuously provide bactericidal efficacy for days, weeks or months. As these products can provide additional disinfection or sanitization between the regular disinfection or cleaning cycles, products must undergo bactericidal efficacy testing and meet criteria set forth by the EPA before making bactericidal claims. Our consultative antimicrobial experts provide industry-leading antimicrobial testing services to support the registration of residual products.

Treated article testing - Objects treated with antimicrobial products intended to protect the article itself are treated articles. Examples of treated articles include textiles, paints, and rubber gloves. Element has extensive experience testing a wide variety of treated articles to established methodology, assisting product developers, manufacturers, and marketers ensure their products meet the criteria for making claims.

Microbiology EN testing - European countries and other jurisdictions require biocidal products regulated by the European Chemical Agency (ECHA) be tested to European Standards. Element offers microbiology EN testing in accordance with the in-depth requirements detailed within the Biocidal Products Regulation (BPR).

Microbiology pesticide/antimicrobial device testing - Devices that produce an antimicrobial product or act as the antimicrobial, such as UV, sterilizing, steam, ozone, and ionizing devices are antimicrobial pesticide devices. The regulation of these devices is complicated, as either the FDA or EPA can be responsible for regulation in the US. Successfully navigate the complex regulations for these devices and generate required efficacy data to support claims with the support of Element’s consultative regulatory and scientific experts.

For more information about our antimicrobial microbiology testing services or to request a quote, contact us today.