Cleaning and Clean Room Disinfectant Validation

Disinfectant Validation and Efficacy Testing

Disinfectant Validation Studies are an FDA requirement to demonstrate the broad-spectrum antimicrobial efficacy of one or more disinfectant products employed for pharmaceutical production area qualification prior to use. Test designs are custom to the specific disinfectant(s) chosen by the facility, application method, contact time, surface materials cleaned and relevant microbes (some isolated from the validation site). Every pharmaceutical manufacturing facility is unique, which is why we tailor our approach to meet your specific needs. Our comprehensive clean room disinfectant validation service supports your precise process validation needs.

Microbial Inactivation, Removal, and Contamination Control

Cleaning validation assures the effectiveness of site-specific methods and materials to assure the inactivation or removal of microorganisms. Our laboratory offers an extensive library of organisms to help you reduce the risk of microbial contamination. Organism types we routinely validate against include:

• Viruses (Including BSL-3 Strains)

• Bacteria (Including Resistant Isolates)

• Fungi

• Bacterial Spores

Biofilm and Biosafety Level - 3 Capabilities

Our Bozeman, MT facility offers further specialized validations against specific problem microorganisms. We host a state-of-the-art, Biosafety Level -3 laboratory in which we validate disinfectant efficacy against the most relevant pathogens today. Strains including Sars-CoV-2, H7N9, and Moneypox virus are all offered as validation targets for your process and disinfection.

Along BSL-3, Nelson Labs Bozeman also offers an industry leading Biofilm efficacy validation service. Our team of experts offer a comprehensive validation service to ensure your processes effectiveness of Biofilm inactivation and removal. Supported by decades of complex study design experience, our team is prepared to design the study to meet your facilities contamination control needs.

Key elements of the study include:

• Specific surface materials and disinfectants associated with your site
• Microbiological testing for both antimicrobial and antiviral efficacy
• QAU oversight and review to ensure data quality
• Over 30 years of experience and numerous FDA efficacy validation submissions.
• Nelson Labs Bozeman is an EPA registered, GLP and ISO accredited laboratory.

In-Vitro Testing Laboratory

Scientists in our In-Vitro testing labs are well trained on ASTM, AATCC, AOAC, CLSI and EN standard methods. The efficacy testing services of this laboratory include MIC/MBC, ...