Product Safety Labs (PSL) performs sanitizing, disinfection and antimicrobial efficacy studies on active ingredients and formulations for global regulatory submission.
These services are available as screening tests for research and development purposes or can be conducted under GLP to meet your registration requirements (OECD, EPA, FDA).
Testing services provided by PSL include:
- Disinfectant and sanitizing efficacy tests on antimicrobials following appropriate guidelines (OPPTS 810.2000 to 2300) and according to the relevant ASTM and AOAC efficacy methods and the EPA OPP microbial SOPs.
- ASTM and EN efficacy tests on volunteers to evaluate efficacy on hand sanitizers (against bacteria, fungi and viruses).
- Disinfection and sterilization studies on compounds used on medical equipment as required by FDA (510k or PMA).
- MIC (minimum inhibitory concentration), MBC (Minimum Bactericidal Concentration), time-kill tests on new substances and mixtures at R&D stage.
In addition to being able to conduct studies that conform to standard regulatory test requirements, PSL is also capable of designing customized test methods to evaluate efficacy against a large portfolio of BL2 and BL3* bacteria, yeasts, molds spores, bacterial spores, mycobacteria, viruses and algae, in order to support specific marketing claims. Our capabilities cover a range of efficacy services including tests conducted in vitro, on carriers which simulate the product’s actual use as well as on human volunteers (up to BL2 safety level) and –if necessary– under ethical committee supervision depending on the specific product application.
For European registration, PSL can also assist with all CEN and ISO efficacy test methods necessary for the registration of CE disinfectants, biocides (disinfectants classified as PT1 to PT5 in EU Biocidal Product Regulation), preservatives and surface antimicrobials (classified as PT6 to PT13 in EU Biocidal Product Regulation).
The extensive expertise our team has developed allows us to actively support our client’s development of formulations for disinfection and sanitization of skin, surfaces, equipment as well as filtration efficacy validation of water and air filtration systems.
Call us at Product Safety Labs to speak with one of our experts about your research needs.