And Regulatory Compliance
Evaluating the degree of antimicrobial activity on a medical device is vital for ensuring safety, efficacy and compliance. The product must be free from microbial risk from the likes of bacteria, viruses, and fungi. But knowing when to engage with an external laboratory, what sample sizes are required, or which tests are relevant can be overwhelming, especially with timeline pressures and budget constraints. Delays caused by incomplete or repeat testing can result in additional costs, missed deadlines, and even regulatory setbacks.
Eurofins Medical Device Services network of laboratories provides the expertise, guidance, and testing solutions needed to keep your project on track. Our team of experienced microbiologists determine the most applicable antimicrobial solution to suit your medical device depending on components, application, and intended end use. With a full range of antimicrobial services to evaluate the effectiveness of medical devices against bacteria, fungi, mould, and viruses. Our capabilities are built to ensure your device is safe for use, effective in application, and compliant with all relevant regulations, no matter if you are testing antimicrobial finishes, preservatives, or surfaces. This testing helps to avoid microbial proliferation and biofilm formation on the device, amongst other concerns, and substantiate a claim.
Our labs use industry-standard and custom protocols tailored to the components and end-use of your device. Each method is performed using carefully selected strains, depending on your product's intended use. We offer guidance in assessing the impact of changes in materials, sterilisation, or manufacturing methods. Our commitment to open communication and regulatory insight ensures you avoid testing delays, stay ahead of compliance requirements, and eliminate uncertainty during development.
We use a microwell plate to test a dilution series of liquids and other soluble substances with possible antimicrobial activity with different bacterial or fungal test strains of interest. The plates are then incubated under appropriate conditions. Growth or no growth is a measure for the minimum inhibitory concentration. Additional plate counts help to determine the minimum bactericidal concentration.
Our experts perform a visual evaluation of the zone of inhibition around and under a sample of textile fabrics on an Agar diffusion plate. Test strains: Staphylococcus aureus (ATCC 6538), Escherichia coli (ATCC 11229), Klebsiella pneumonia (ATCC 4352).
Our scientists perform a dynamic shake flask test to determine the activity of antimicrobial agents in powder, paper, solid materials and/or surfaces under dynamic contact conditions. Test strain: Escherichia coli (ATCC 8739).
We will measure the activity of antibacterial-treated plastics, metals and other non-porous surface products, including intermediate products in direct contact. Products tested should be sterile or disinfected prior to testing as testing occurs on the exposed outer surface. Test strains: Staphylococcus aureus (ATCC 6538), Escherichia coli (ATCC 8739) and other species, if required.
Similar to ISO 22196, our experts determine the antimicrobial activity of textile products through absorption. Test strains: Staphylococcus aureus (ATCC 6538), Klebsiella pneumoniae (ATCC 4352).
Our testing determines the activity of incorporated antimicrobial agents in polymeric or hydrophobic materials through a direct contact method with solid materials. Test strains: Staphylococcus aureus (ATCC 6538), Pseudomonas aeruginosa (ATCC 15442), Klebsiella pneumoniae (ATCC 4352).
We perform this method as a quantitative procedure for the comparison and evaluation of the degree of antibacterial activity on a test fabric, compared against an untreated control. Test Strains: Staphylococcus aureus (ATCC 6538), Klebsiella pneumonia (ATCC 4352) and other species, if required.
Our experts determine the effectiveness of a medical device’s preservative system in preventing replication of microorganisms that may be introduced inadvertently to multiple-dose containers subsequent to manufacturing steps. The tests are generally conducted on products intended for parenteral, ophthalmic, oral, topical, or optic use. Depending on device classification, strains may include Staphylococcus aureus (ATCC 6538), Pseudomonas aeruginosa (ATCC 9027), Escherichia coli (ATCC 8739), Aspergillus brasiliensis (ATCC 16404), Candida albicans (ATCC 10231), Zygosaccharomyces rouxii (NCYC 381) and other species, if required.
Our experts utilise an internally developed method per ASTM 1608 to determine the passage of airborne bacteria through porous materials intended for sterile packaging. Samples of porous packaging materials are subjected to an aerosol of Bacillus atrophaeus (ATCC 9372) within the exposure chamber.