Microbiology and Efficacy Testing

An antimicrobial or preservative is defined as a chemical agent that will kill or inhibit the growth of microorganisms. Disinfectant efficacy testing is utilized to measure the effectiveness of chemicals that are used to clean or disinfect surfaces. It confirms that disinfectant agents used are active against organisms isolated during the environmental monitoring program and/or against other relevant organisms.

Eurofins BioPharma Product Testing Italy performs sanitizing, disinfection and anti­microbial efficacy studies on active ingredients and formulations for EPA, FDA, EU BPR and MDR submission, in the medical, veterinary, industrial, or domestic areas according to national and international standards. Services offered are available, as screening tests during R&D phase, or can be conducted under ISO17025 or GLP to meet your registration requirements (OECD, EPA, FDA).

• We have the experience to perform official and customized test methods against a huge portfolio of BL2 bacteria, yeasts, moulds spores, bacterial spores, mycobac-teria, mycoplasmas and algae and biofilm in order to comply with regulatory requirements and also support specific marketing claims
• Our expertise allows us to support our client developing, implementing and performing customized testing on different types of formulations for disinfection/sanitization, surface disinfection including airborne disinfection and sanitization of surfaces/equipment
• All microorganisms may be tested in vitro, on carriers, simulating the products actual use and on human volunteers (up to BL2 safety level)
• We are also capable to carry on all CEN and ISO efficacy test methods necessary to the registration of CE disinfectants (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) in the European Union.
• Our expertise can support you at all stages of the design, trial and manufacturing process for medical devices, coatings, packaging, textiles, industrial surface disinfectants, cosmetics and other healthcare products.

   

Eurofins BioPharma Product Testing Italy offers a comprehensive range of antimicrobial efficacy testing for a range of products such as medical devices, textiles, industrial surface disinfectants, cosmetics and healthcare products. These services are aligned to support our clients at all stages of the design, trial and manufacturing process.

Our microbiology services include:

• Sterilant, disinfectant and sanitizing efficacy tests on antimicrobials both at R&D and regulatory stage according to EPA OCSPP 810, 2000 to 2300 series
• ASTM efficacy tests on volunteers to evaluate efficacy on hand sanitizers (against bacteria, fungi and viruses)
• Disinfection and sterilization studies on disinfectants and sterilants for medical equipment for FDA (510k or PMA) submission
• MIC (minimum inhibitory concentration), MBC (Minimum Bactericidal Concentra-tion), time-kill tests on new substances and mixtures at R&D stage.
• Antimicrobial Coating efficacy testing (surfaces, textile etc..)

All of our disinfectant efficacy tests are tailored to each of our clients individually. Our experience with performing this range of testing ensures that you receive results specific to your environment and your disinfectants.