Regulatory agencies require proof of efficacy against specified pathogens before approving label claims. This proof of efficacy is especially important during the current global COVID-19 pandemic.

Element offers GLP virology testing options to serve our clients in the antimicrobial industry, including disinfectant products tested against SARS-CoV-2 and the Alpha (B.1.1.7) and Delta variants, causative agents of COVID-19. Our scientists possess years of virology experience, working with a variety of viruses and methods to meet clients’ needs with high quality results in a timely fashion. We can help you expand your product efficacy claims. Our GLP-compliant virology testing complements our antimicrobial efficacy testing services through product tests against viruses commonly requested for use in household, hospital and veterinary spaces.

We also provide cGMP molecular cell biology and virology testing services for pharmaceutical products, including cell banking and product safety testing. Our testing provides additional peace of mind that your products are free from contamination and safe for use. 

For more information about our GLP or cGMP virology testing services or to request a quote, contact us today.

COVID-19 viral

GLP Virology Testing Services

Our GLP-compliant virology testing complements our antimicrobial efficacy testing services through product tests against viruses commonly requested for use in household, hospital and veterinary spaces.

Tests we offer
  • ASTM E1053 Standard Test Method for Efficacy of Virucidal Agents Intended for Inanimate Environmental Surfaces
  • ASTM E1052 Standard Test Method for Efficacy of Antimicrobial Agents Against Viruses in Suspension
  • Virucidal Efficacy Validation of a Disinfectant Used to Clean and Disinfect the Exterior Surface of Blood Glucose Monitoring Devices Utilizing Duck Hepatitis B Virus as a Surrogate for Human Hepatitis B Virus
  • Electrostatic Sprayer Testing
  • Virucidal Efficacy of a Disinfectant Applied to a Room via a Fogger or Misting Device
  • Disinfectant Qualification Testing for Antiviral Activity
  • AATCC 100 Assessment of Antibacterial Finishes on Textile Materials Modified for Virucidal Efficacy
  • Residual Viral Efficacy per EPA Interim Guidance
Biofilm
cGMP virology testing

cGMP Virology Testing Services

Our cGMP-compliant molecular cell biology and virology testing complements our pharmaceutical product testing and includes mycoplasma, cytotoxin and endotoxin testing, among other services.

Tests we offer

USP <63>, EP 2.6.7 Mycoplasma Tests

USP <87> Biological Reactivity Tests, ISO 10993-5, Cytotoxicity

Custom Studies

  • Assay Development and Validation
  • Cell Line Generation
  • Potency and Safety
  • Impurity

cGMP Cell Bank Production and Characterization

  • Mammalian Cell Bank
  • Microbial Cell Bank

Safety Testing

  • Microbiological Contaminants, including Sterility and Mycoplasma tests
  • Retroviruses
  • Adventitious Viruses
  • Endotoxin: LAL
  • Residual DNase, RNase and Protease Activities
  • Cells at the limit of in vitro cell age or end of production cells
  • Unprocessed Bulk
  • Final Filled Product

 

Cytotoxicity testing

Viral Library

Nearly 190 Years of Making Certain

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