Custom Study Set-Up
Custom virucidal studies can be performed for device testing, on-site antimicrobial active ingredient generators, and many other product types. All studies can be conducted according to EPA and FDA regulatory efficacy requirements, and customized according to the unique needs and timelines of the Study Sponsor with the confidentiality and professionalism that is respected industry-wide.
In every case, the test methods to be implemented is carefully considered and tailored, employing modifications to standard test methods, controls, and techniques as appropriate. Common areas of custom testing modification include:
- Carrier Type and Dimensions
- Inoculation Area and Inoculation Volume
- Dry Times, Dry Temperatures, and the Inclusion of Interfering Substances Such as Serum or Blood
- Exposure Time
- Exposure Distance
- And More!
Scientists at Microchem Laboratory will work with you to establish a scientifically defensible and efficient study that provides you with the data you need, when you need it.
Custom Study Regulatory Guidelines
The US EPA and FDA require that the following criteria (among others) be met in order for the test substance/device to be considered for a disinfectant label claim:
- Complete inactivation of the test virus, to the limit of detection for the selected assay
- If cytotoxicity is observed, the test product demonstrates ≥3.00 log10 reduction.
Why Use Microchem Laboratory for Your Custom Study?
- Experienced, expert staff
- Streamlined and cost effective study designs
- Expedited study timelines
- Robust, reproducible virological science
Custom virucidal efficacy studies performed in accordance with US EPA and FDA criteria are one of our specialities!Antimicrobial