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Medical Device Testing

Medical Device Microbiology Testing for Ultimate Quality Assurance


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NAMSA’s world-class Contract Research Organization (CRO) testing capabilities include all areas of microbiological quality assurance. Our facilities contain laboratories for bacteriology and sterility testing, clean rooms, aging chambers and media preparation areas.

Beyond sterility assurance programs, we also offer the following medical device microbiology testing services to clients worldwide:

  • Antimicrobial Testing
  • Bacterial Endotoxin (LAL)
  • Cleaning Efficacy Studies
  • Comparative Resistance Studies
  • Microbial Identification
  • Genotypic/MicroSEQ®
  • Microbiological Examination of Non-Sterile Products, USP <61> and USP <62>
  • Product Inoculation Testing
  • Raw Material Bioburden
  • Reusable Device Studies (cleaning, disinfection and sterilization)
  • Surface Disinfection Studies
  • Test Development
  • Validation of Microbial Recovery
  • Microscopy Techniques
  • Physical property assessment

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.

Microorganisms such as bacteria, fungi and yeast can exist as free-floating planktonic entities or they can attach to a surface (or one another) to form a microbial biofilm. Microorganisms living beneath a biofilm are significantly less susceptible to antimicrobial agents (and the host’s immune system). Standard microbiological testing, however, focuses almost exclusively on planktonic bacteria. As such, current standard testing may underestimate the quantity of active agent required to remove a microbial biofilm effectively.

Chronic wounds are a worldwide health issue. Studies have found that treating biofilms has a beneficial impact on chronic wound healing. Accredited biofilm test models allow benchmark testing of new and existing wound care technology. Perfectus Biomed, acquired by NAMSA, was the first CRO to receive UKAS 17025 accreditations for biofilm methods, including both in vitro and ex vivo test models. Models include MBEC, CDC reactor, drip flow model and single tube method, ex vivo porcine lung model and ex vivo burn wound model. These models are highly customizable and can be adapted to reflect real-world use of the device.

What we offer:
ISO 17025 Accredited Methods:

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

ISO 9001 Methods:

  • Colony Drip Flow Reactor Model
  • Porcine Skin Explant Drip Flow Model
  • Ex Vivo Human Skin Model
  • Single and Multi-Species Biofilm Assays
  • Bacterial and fungal biofilm assays
  • Microtitre Plate Assay
  • Flow Cell Reactor Model
  • In line ‘Robbin’s Device’ Biofilms Models

Viricidal efficacy testing is imperative to assess the activity of a variety of products against viruses. Infection prevention is a key topic for clinicians, and methods such as viral barrier testing for wound dressings and viral cleaning studies for medical devices can support anti-viral claims. Methods can be customized to mimic real-life scenarios, and produce robust data that supports regulatory claims.

What we offer:

  • TCID50 (Median Tissue Culture Infectious Dose)
  • ISO 18184 – Determination of Antiviral Activity of Textile Products
  • ASTM E1052 – Standard Test Method for Efficacy of Antimicrobial Agents Against Viruses in Suspension
  • ASTM E1053 – Standard Test Method to Assess Virucidal Activity of Chemicals Intended for Disinfection of Inanimate, Nonporous Environmental Surfaces
  • ASTM E2197 – Standard Quantitative Disk Carrier Test Method for Determining the Virucidal Activities of Liquid Chemical Germicides
  • EN 16777 – Chemical Disinfectants and Antiseptics- Quantitative Non-Porous Surface Test Without Mechanical Action for the Evaluation of Virucidal Activity of Chemical Disinfectants Used in the Medical Area
  • EN 14476 – Chemical Disinfectants and Antiseptics – Quantitative Suspension Test for the Evaluation of Virucidal Activity in the Medical Area
  • EN 22442: Medical devices utilizing animal tissues – Viral inactivation studies
  • ISO 21702 – Antimicrobial Surface Test
  • EN 17272 – Airborne Room Disinfection
  • Durability Assessments
  • Virus Infected 3D Reconstructed Airway Models
  • Aerosolised Virus Testing
  • Pre-Saturated Towelettes Virucidal Effectiveness Test
  • Viral Barrier Testing


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