Disinfection Qualification

You need confidence in the ability of your antimicrobial products and procedures to eliminate contaminants in your facility. With more than 30 years of experience performing disinfectant efficacy studies and disinfection qualification studies, our experienced, consultative team will partner with you to ensure safety is never compromised.

Disinfectant efficacy and disinfectant qualification for controlled manufacturing environments 

Disinfection qualification formally evaluates the efficacy and suitability of antimicrobial products and procedures used to eliminate contaminant microorganisms and viruses on various surface types and components within an aseptic, sterile or otherwise controlled manufacturing environment. Using GLP methods, disinfectant efficacy testing formally evaluates the efficacy and suitability of antimicrobial products used to eliminate contaminant microorganisms on various surface types and components.

Element complies with USP <1072> disinfectant qualification methods and will partner with you to help you develop an effective cleaning/disinfection regimen for your controlled spaces. We can test your surfaces, using the application methods and products that will be used in your facility against Sponsor provided or Element acquired microorganisms and viruses to generate data to support your practices. Our disinfectant efficacy studies evaluate the effectiveness of disinfectants used in your facilities and provide you with solid GLP or cGMP data.

To learn more about our services, contact us today. 

Disinfectant qualification test methods

Disinfectant Qualification for Bacteria, Yeast, and Spores - Representative surfaces found in the GMP manufacturing facility are inoculated with test organisms utilized in the manufacturing production plus any routine microbiological contaminants isolated by the facility during the manufacturing process. The surfaces are disinfected using the disinfection practices commonly used at the facility. Following treatment, the surfaces are assayed for surviving organism. The level of reduction deemed necessary for appropriate disinfection is determined by the GMP facility performing the qualification testing.

Disinfectant Qualification Testing for Antiviral Activity - Representative surfaces found in the GMP manufacturing facility are inoculated with test viruses utilized in the manufacturing production plus any routine viral contaminants isolated by the facility during the manufacturing process. The surfaces are disinfected using the disinfection practices commonly used at the facility. Following treatment, the surfaces are assayed for surviving viruses by an assay method specific for the test virus. The level of reduction deemed necessary for appropriate disinfection is determined by the GMP facility performing the qualification testing.

Disinfection qualification for the pharmaceutical industry 

Using cGMP methods, Element's antimicrobial experts evaluate the efficacy and suitability of antimicrobial products and procedures used to eliminate contaminant microorganisms on various surfaces and items within an aseptic, sterile or controlled manufacturing environment. Our comprehensive disinfection qualification services comply with USP <1072> disinfection qualification methods. Our consultative team will partner with you to develop an effective cleaning regimen for your controlled manufacturing spaces. 

To learn more about our services, contact us today.

The Element advantage

Partner with Element today to ensure the safety of aseptic, sterile, and controlled environments with our comprehensive disinfection qualification services. With more than 30 years of experience serving as the premier partner to manufacturing organizations with controlled environments, our disinfectant efficacy studies evaluate the effectiveness of disinfectants and procedures used in facilities and provide solid GLP or cGMP data.

To learn more about our disinfection qualification services, learn about additional methods available or to speak with an expert, get in touch with us today.