Medical Device Microbiology Testing Lab Services

Why Companies Trust NAMSA

NAMSA is the pioneer of the medical device testing industry and continues to serve as the global marketplace leader for trusted microbiology testing services. We take pride in managing your testing program, supporting accelerated project timelines, and delivering consistent, expert results that are highly recognized and accepted by global regulatory authorities.

  • Expertise: Our team has extensive experience in microbiology testing for medical devices.
  • Quality: We adhere to the highest standards of quality and accuracy in all our testing services.
  • Customer Focus: We work closely with you to understand your needs and provide personalized solutions.
  • Timely Results: Our efficient processes ensure you receive timely, reliable results.

Deep Expertise in Microbiological Testing

NAMSA’s world-class facilities and laboratories are where our team conducts all facets of microbiological quality assurance. Our labs host bacteriology and sterility testing, clean rooms, aging chambers, and media preparation areas to provide our clients with the most holistic and thorough testing services.

Bioburden Testing

Every year NAMSA laboratories in the US and Europe conduct more than 100,000 tests measuring biocompatibility, package integrity, microbiology, and sterility. Bioburden testing is among the most important of those tests, measuring microbial contaminants that originate from the final cleaning, human handling, airborne particulate, of microbes bacteria found in and around the manufacturing environment. NAMSA can analyze the bioburden of your devices, assist in the determination of the root cause for excursions, and help you lower it to acceptable CFU levels.

LAL Endotoxin Testing

LAL (Limulus Amebocyte Lysate) testing, also known as bacterial endotoxin testing, is crucial for medical device manufacturers to ensure the safety and efficacy of their products by detecting bacterial endotoxins. These endotoxins, found in the cell walls of gram-negative bacteria, can cause severe reactions if present in medical devices. The LAL test includes the Kinetic Turbidimetric, and Kinetic Chromogenic methods, each offering high sensitivity and regulatory compliance. By incorporating LAL testing, manufacturers can meet stringent safety standards and protect patients from harmful endotoxins.

Any device that comes in direct or indirect contact with the cardiovascular system, cerebrospinal fluid, or lymphatic system must undergo bacterial endotoxin testing to confirm the device’s endotoxin content is below the device specification.

Biofilm Testing

Microorganisms like bacteria, fungi, and yeast can exist as free-floating planktonic entities or attach to a surface — or one another — to form microbial biofilms. These biofilms can form anywhere — including on medical devices, which introduces risks to both patient health and treatment efficacy. Standard microbiological testing focuses almost exclusively on planktonic bacteria. As such, current standard testing often underestimates the quantity of active agents required to effectively remove a microbial biofilm. At NAMSA, we understand the significance of biofilms as a worldwide health issue, which is why we strive to ensure the reliability, accuracy, and competence of all our biofilm testing.

  • Minimum Biofilm Eradication Concentration (MBEC)
  • CDC Biofilm Reactor
  • Ex vivo Burn Wound Model
  • Drip Flow Biofilm Reactor
  • Single Tube Method

Shelf-Life Testing

Shelf life testing is a crucial process used to determine how long a product remains safe, effective, and suitable for use.  Accelerated aging studies are designed to increase the rate of chemical degradation or physical change of a substance or product by using exaggerated storage conditions as part of the formal stability study. Data from these studies, in addition to long-term stability studies, can be used to assess longer-term chemical effects of non-accelerated conditions and to evaluate the effect of short-term excursions outside the label storage conditions.

Intermediate accelerated aging studies conducted at 30°C and 65% relative humidity (RH) are designed to moderately increase the rate of chemical degradation or physical changes for a substance or product intended to be stored in hotter climatic zones. Long-term studies designed to represent real-time use as required by the FDA are also available under the recommended storage conditions for the shelf life proposed (or approved) in the label claim.

Environmental Monitoring

When it comes to meeting quality system regulations, especially when specific environmental conditions could impact medical device performance, environmental monitoring services are essential. At NAMSA, our team of medical device testing experts brings extensive experience to efficiently provide you with comprehensive testing protocols and data management. Our services support your full sterility assurance program, ensuring your products meet the highest standards of safety and compliance. We offer a wide range of tests, including airborne particle counts, microbial identification, water testing, and many more. By leveraging our expertise, you can confidently maintain the quality and effectiveness of your medical devices, ensuring they perform reliably under various environmental conditions.

Trust NAMSA to deliver precise and reliable environmental monitoring services that help you achieve regulatory compliance and uphold the highest standards of product safety and quality.

Packaging Testing and Validation

Packaging validation and shelf life testing are essential components of any medical device sterility assurance program. NAMSA’s suite of validation tests ensure that sterility is maintained when a device is sealed until expiration. We follow stringent protocols to assess factors like sealing strength, barrier properties, and resistance to environmental stressors. We can assist with all testing required for materials, equipment and process qualification. Trust our expertise to maintain the highest standards of safety and compliance for your medical device packaging needs. Services include, but are not limited to:

  • Accelerated Aging (ASTM F1980 and AAMI TIR 17)
  • Barrier Properties (ASTM F1608)
  • Biocompatibility (ASTM F2475)
  • Burst Testing (ASTM F1140)
  • Dye Penetration (ASTM F 1929)
  • Gross Leak Test (ASTM F2096)
  • Seal Tensile Strength (ASTM F88)
  • Shipping Simulation (ASTM D4169, D7386 and ISTA or custom programs)
  • Vacuum Leak Bubble Emission (ASTM D3078)

Antimicrobial Testing

Antimicrobial testing is vital for ensuring the safety and effectiveness of medical devices. In addition to biocompatibility testing, the antimicrobial efficacy of your test article should be determined. NAMSA provides comprehensive services, including protocol and final summary report development as well as testing for feasibility and regulatory submission. Our expertise in antimicrobial testing supports your efforts to meet regulatory requirements and maintain high standards of product quality and safety.  This testing includes:

  • AATCC Test Method 100 (Standard microorganisms tested are Staphylococcus aureus and Klebsiella pneumonia but additional testing can be done for particular fungus and bacteria.)
  • AATCC Test Method 147
  • AATCC Test Method 174
  • ASTM E2149 Test Method
  • Minimum Inhibitory Concentration
  • Zone of Inhibition

Microbial Identification Testing

To monitor the type of living microorganisms on a medical device, identifications are required. But, several techniques can be used to identify the microorganisms. Medical device manufacturers are commonly challenged by Notified Bodies (NBs) to justify the technique for microbial identifications they are using, and the precision of the results obtained.

The most efficient strategy to analyze bioburden content is to determine which microorganism types are representative of each contamination source (not exhaustively: Gram-positive for environment, Gram-negative for water-mediated contamination, fungi for storage and moisture presence, etc.) and to focus only on the most challenging germs (hand-carried, radioresistant, etc.) for the manufacturer risk analysis.

With world-class microbiology testing capabilities, global state-of-the-art facilities, and unmatched expertise, NAMSA is well-equipped to support your microbial identifications and analyze the obtained results. Our experienced and dedicated team can help you navigate regulatory obstacles and recommend testing requirements according to the standards.

Why Companies Choose NAMSA

25K +

Bioburden Tests Conducted Last Year

13K +

Endotoxin Tests Conducted Last Year

425

Biofilm Tests Conducted Last Year

118K +

Medical Device Tests Conducted Last Year

Broad Range of Testing Available

Getting it right from the start translates into resource savings throughout the development continuum, allowing you to accelerate market introduction and to cost-effectively bring life-improving therapies to those who need them most. Our unmatched expertise ensures accurate testing and streamlined timelines, guaranteeing exceptional results.

Our state-of-the-art laboratories in the US and Europe offer the following medical device microbiology testing services to clients worldwide:

  • Antimicrobial Testing
  • Bioburden Testing
  • Bacterial Endotoxin (LAL)
  • Cleaning Efficacy Studies
  • Environmental Monitoring
  • Microbial Identification
  • Genotypic/MicroSEQ
  • Packaging Testing
  • Product Inoculation Testing
  • Physical Property Assessment
  • Reusable Device Studies
  • Shelf Life Testing
  • Surface Disinfection Studies
  • Test Development
  • Validation of Microbial Recovery

Custom Microbiology Testing Support

Medical devices are inherently variable and utilizing standard methods can be difficult when a product doesn’t fit the method or when the clinically relevant organisms are not standard (including fungi, yeast, and anaerobes). NAMSA aims to support the regulatory demand for clinically relevant in vitro data by developing and delivering high-end, regulatory-accepted, customized in vitro testing. Methods are developed to meet the project’s specific needs and reflect the real-world use of a device. These customized methods can be used to screen multiple formulations to identify leading products.

Regulatory Compliance

We are committed to helping you navigate the complex regulatory landscape. Our testing services comply with global standards, including ISO, USP, EP, and JP. We provide comprehensive documentation and support to ensure your products meet all regulatory requirements.

Meet Our Team of Microbiology Experts

Explore the depth of our team’s expertise in medical device testing.

Meet Our Full Team
  • Julie S. Tuinstra

    Validation Scientist
    View Bio
  • Marie-Eve Cluzel-Valentin

    Principal Biological Safety and Validation Scientist
    View Bio
  • Ed Arscott, BS

    Principal Strategy Consultant, Microbiology
    View Bio
  • Shazia A. Siddiqui, MS, NRCM

    Principal Microbiologist
    View Bio
  • Shelley L. Green, BS

    Senior Validation Scientist
    View Bio
  • Frédéric Cadoret, PhD

    Senior Study Director, Sterility Assurance
    View Bio

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