Virology Testing

Your antimicrobial products need proven virucidal efficacy data for regulatory approval and market differentiation. Element's comprehensive GLP/cGMP virology testing delivers defensible results for global regulatory submissions—with expert guidance, accelerated timelines, and custom protocols tailored to your specific products. Our 30+ years of experience and regulatory defense support successful product registrations.

Comprehensive GLP virology efficacy testing to EPA, FDA, TGA & Health Canada requirements
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What is Virology Testing at Element?

Virology testing evaluates how effectively products reduce, destroy, or inactivate viruses on surfaces, in materials, or in suspension. At Element, we provide complete virucidal efficacy testing services for antimicrobial products, pharmaceuticals, disinfectants, sanitizers, and treated articles. Our GLP and cGMP-compliant laboratories test against a wide array of BSL2 and BSL3 human and veterinary viruses, including SARS-CoV-2 variants, with specialized expertise in testing emerging viral threats, to support your product claims and regulatory submissions worldwide.

Element life sciences testing expert in lab

What Can Element Offer You For Virology Testing?

Key Tests Offered

Your regulatory submissions demand comprehensive testing services tailored to your specific product claims. Element's complete virucidal testing portfolio supports your entire product development journey from initial screening to final submission. Our industry-leading virologists deliver testing for standard and specialized claims, including virucidal efficacy for direct-contact disinfection, residual protection, treated articles, and more. 

  • GLP virucidal efficacy testing for regulatory submissions 
  • Residual virucidal efficacy testing for long-lasting claims 
  • Treated article virucidal testing (fabrics, surfaces) 
  • Disinfectant and sanitizer virucidal testing 
  • EN virucidal testing for European regulatory compliance 
  • cGMP virology testing for pharmaceutical products 
  • Custom protocol development for unique applications 

Products We Test

Your antimicrobial products require different testing approaches based on their formulation and application method. We test liquid disinfectants, aerosol sprays, pre-saturated towelettes, treated fabrics and surfaces, residual/long-lasting antimicrobial products, and pharmaceutical products. Our testing capabilities extend across household, hospital, and veterinary applications, ensuring your product efficacy data meets the specific requirements for your intended market. 

  • Hard surface disinfectants (liquids, sprays, wipes) 
  • Soft surface antimicrobials (fabric treatments, laundry additives) 
  • Long-lasting residual products (coatings, treated surfaces) 
  • Copper-containing antimicrobial surfaces 
  • Antimicrobial pesticide devices

Methods And Solutions Offered

Your product's unique formulation and application require specialized testing methodologies tailored to its specific characteristics. We offer comprehensive testing approaches including suspension-based methods, hard and soft surface evaluations, residual efficacy with wear simulation, surrogate virus testing, and specialized techniques for pharmaceuticals. Our methods support both standard and custom testing protocols across all major regulatory frameworks. Additionally, we provide specialized methodologies for assessing the degree of homogeneity and distribution of virucidal active ingredients, and testing for viral contamination in cell cultures and cell banks compliant with 21 CFR Part 58. 

  • Suspension-based testing (ASTM E1052, BS EN 14476, BS EN 14675) 
  • Hard surface testing (ASTM E1053, BS EN 16777) 
  • Soft surface testing (fabric, laundry additive) 
  • Residual efficacy testing with wear simulation 
  • Surrogate virus testing for difficult pathogens 
  • Topical skin products using ex-vivo models 
  • Disinfection validation/qualification (USP 1072) 
  • Custom protocol development for specialized applications 

Regulatory expertise advantage

Your products face complex regulatory hurdles that vary across global markets. Our consultative experts stay current with evolving requirements from major regulatory bodies worldwide, helping you navigate the specific data needs for your product claims. We provide complete regulatory dossier preparation and submission support, and we stand by your side throughout the review process to defend results if questions arise.

  • US Environmental Protection Agency (EPA) submission support 
  • US Food and Drug Administration (FDA) requirements 
  • Health Canada registration guidance 
  • Australian Therapeutic Goods Administration (TGA) compliance 
  • European Chemicals Agency (ECHA) testing standards 
  • Support for both GLP and non-GLP testing requirements 
  • Assistance with treated article exemption and related claims 

Which Labs Offer This Service

Element’s Life Sciences network includes dedicated facilities for both antimicrobial and pharmaceutical testing. Element Eagan is recognised as a premier antimicrobial testing laboratory, while Element Concord is known for its expertise in pharmaceutical testing services. Beyond these key sites, our team operates from Life Sciences hubs across the world, providing global access to our expert capabilities. Find your nearest Life Sciences hub on our Locations Page.

Standards we test to and products we test

These are our most prevalent requests. Don't see what you're looking for? Contact us!
  • 21 CFR Part 58 (Good Laboratory Practice for Nonclinical Laboratory Studies)
  • ASTM E1052 (Efficacy of Antimicrobial Agents Against Viruses in Suspension)
  • ASTM E1053 (Efficacy of Virucidal Agents for Inanimate Environmental Surfaces)
  • BS EN 14476 (Virucidal Activity in the Medical Area)
  • BS EN 14675 (Virucidal Activity in the Veterinary Area)
  • BS EN 16777 (Non-Porous Surface Test for Medical Area)
  • TM 100/AATCC 100 Modified for Virucidal Efficacy
  • ISO 18184 (Determination of Antiviral Activity of Textile Products)
  • JIS Z 2801/ISO 21702 Modification (Antiviral Activity and Efficacy)
  • USP <63>, EP 2.6.7 (Mycoplasma Tests)
  • USP <87> (Biological Reactivity Tests)
  • USP 1072 (Disinfection Validation/Qualification)

Your Challenges, Our Solutions

Checklist

Complex regulations simplified for faster approvals

Your products must meet specific regulatory requirements across different agencies and markets. Our consultative experts continuously track EPA, FDA, TGA, Health Canada, and ECHA regulations, guiding you through the submission process with precision and defending your data if questions arise during review.
Checklist

Defensible efficacy data that strengthens your claims

Your antimicrobial products need scientifically sound evidence against specific pathogens to support marketing claims. Our GLP-compliant laboratories provide comprehensive testing against human and veterinary viruses including SARS-CoV-2 variants, delivering high-quality results that withstand regulatory scrutiny and market demands.
Checklist

Customized solutions for your unique products

Your specialized products—from residual disinfectants to treated articles—require tailored testing approaches. We develop and execute both standard and custom protocols to address your specific product characteristics, whether you need residual efficacy testing, treated article evaluation, or specialized pharmaceutical assessment.
Checklist

Accelerated timelines for faster market entry

You face pressure to launch products quickly, especially during public health emergencies. Our responsive teams deliver timely results with consistent turnaround times and options ranging from preliminary screening to required GLP submissions, helping you compress development cycles without compromising data quality or regulatory compliance—a capability we significantly expanded during the COVID-19 pandemic.

Why Choose Element

Element scientist in white lab coat working in life sciences testing laboratory

Virucidal testing expertise

Industry-leading virologists with decades of experience testing across all product categories and claim types.

Regulatory submission success

Proven track record supporting thousands of successfully registered antimicrobial products with defensible data.

Comprehensive virus capabilities

Testing against a wide array of BSL2 and BSL3 human and veterinary viruses, including SARS-CoV-2 variants.

Custom protocol development

Specialized testing methodologies tailored to your unique product formulations and application methods.

30+
years

generating GLP-compliant antimicrobial data

24/7

access to your test result information

28

Viruses in our viral library
Element laboratory scientist placing raw materials sample in test chamber for controlled testing conditions
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Speak to our team of experts

AMERICAS

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+1 888 786 7555

EUROPE

Contact our Central Team
UK

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+44 808 234 1667

Germany

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+49 800 000 5137

MIDDLE EAST

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+971 800 353 6368