Antimicrobial Activity Testing

The development and registration of medical devices demand rigorous evaluation of safety and efficacy, with antimicrobial performance being a critical aspect for products that contact patients, healthcare workers, or the environment. Antimicrobial activity testing is specifically designed to assess the ability of a medical device or its materials to inhibit the growth of microorganisms or to kill them. The primary purpose of this testing is to validate any antimicrobial claims, ensure product safety by reducing the risk of healthcare-associated infections (HAIs), and comply with regulatory requirements set forth by agencies such as the FDA (U.S. Food and Drug Administration) and EMA (European Medicines Agency). For device manufacturers, conducting robust antimicrobial testing is not merely a regulatory hurdle; it is a necessary step to demonstrate product effectiveness, build market confidence, and ultimately safeguard public health.

Our Service

Meditronics (a brand of STEMart) offers a comprehensive suite of antimicrobial activity testing services tailored to meet diverse regulatory and product-specific needs. Our testing protocols strictly adhere to internationally recognized standards, including ISO, ASTM, AATCC, and USP, ensuring globally acceptable data for your submissions. We utilize a wide range of representative microbial strains to challenge your products, such as Staphylococcus aureus (ATCC 6538), Escherichia coli (ATCC 8739), Escherichia coli (ATCC 11229), Klebsiella pneumonia (ATCC 4352), Bacillus atrophaeus (ATCC 9372), Pseudomonas aeruginosa (ATCC 9027), Aspergillus brasiliensis (ATCC 16404), Candida albicans (ATCC 10231), Zygosaccharomyces rouxii (NCYC 381), and others depending on the intended use and standard.

Our capabilities include but are not limited to:

• ISO Standards:
  • ISO 20645: Used for testing textile fabrics and other planar materials by agar diffusion plate method, suitable for assessing antibacterial activity.
  • ISO 22196: Designed for measuring antibacterial activity on plastics and other non-porous surfaces. It is highly suitable for hard surfaces of medical devices.
  • ISO 20743: Applicable to antibacterial finished textile products, including fabrics and fibers used in medical textiles.
• ASTM Standards:
  • ASTM E2149: A dynamic shake flask test for determining the antimicrobial activity of agents under dynamic contact conditions, ideal for soluble agents, powders, and treated fabrics.
  • ASTM E2180: A modified shake flask test suitable for assessing the antimicrobial activity of hydrophobic or polymeric materials, coatings, and ion-exchange resins.
  • ASTM F1608: Standard test for evaluating the inherent resistance of porous packaging materials to microbial penetration, which is essential for maintaining the sterility of packaged medical devices over time.
• AATCC Standards:
  • AATCC TM100: A quantitative assessment method for antibacterial finishes on textiles, often used for medical apparel and fabrics.
  • AATCC TM147: A qualitative agar diffusion method (parallel streak) for preliminary evaluation of antibacterial activity on textiles and other materials.
  • AATCC TM174: Specifically for assessing antimicrobial activity of carpets, which could be relevant for certain healthcare settings.
• USP 51: The Preservative Effectiveness Test (PET) is critical for evaluating the efficacy of antimicrobial preservatives in multi-dose parenteral, ophthalmic, oral, and topical products to ensure they remain free from microbial contamination during use.

Fig. 1 Common methods used to evaluate antimicrobial activity ¹

Why Choose Meditronics?

At Meditronics, we deliver a comprehensive antimicrobial efficacy assessment strategy that is critical for your product's regulatory success and market acceptance. Our service is designed to be a seamless and invaluable extension of your R&D and quality assurance process, offering distinct advantages that set us apart.

✔ Expert Guidance on Method Selection

Our team of seasoned microbiologists and regulatory specialists perform a thorough analysis of your device's components, its clinical application, and intended end use to ensure the chosen test methods (e.g., ISO, ASTM, USP) are perfectly aligned with regulatory expectations and product claims.

✔ Unmatched Technical and Methodological Diversity

Our state-of-the-art laboratories are equipped with advanced instrumentation to execute a vast portfolio of standardized and customized assays. This allows us to efficiently test an unparalleled range of materials, from metals, polymers, and ceramics to textiles, liquids, coatings, and porous packaging materials.

✔ Regulatory Compliance and Data Defensibility

With an deep understanding of the global regulatory landscape for medical devices (including FDA, EMA, and other major markets), we ensure that all studies are designed and conducted to generate high-quality, defensible, and audit-ready data. Our rigorous quality control and documentation practices provide the robust evidence needed to support your 510(k), PMA, or CE marking submissions with confidence.

✔ Efficiency and Project Management

Our dedicated project managers ensure transparent communication, provide clear timelines, and deliver timely results, helping to accelerate your regulatory pathway and time-to-market without compromising on data quality or integrity.

Contact us today to discuss your testing needs and request a quote. Let Meditronics be your trusted partner in medical device quality and patient safety.

Reference

• Rebeca G. P., etc. (2023). "Current landscape of methods to evaluate antimicrobial activity of natural extracts." Molecules. 28(3), 1068. Published under an open access Creative Common CC BY 4.0 license.