LexaMed is ISO 13485 Certified, holds a State of Ohio drug license and DEA registration, and maintains a FDA registration for both medical devices and pharmaceuticals. LexaMed offers a full complement of microbiology and chemistry services in our corporate laboratories in Toledo, Ohio. We offer tests to support routine release testing such as sterility tests – product and biological indicator and LAL pyrogen testing. We further offer qualification testing such as disinfectant efficacy, preservative effectiveness and microbial limits testing (USP), D and z-value, steam BIER unit exposures, package and container closure integrity, and tissue culture. We also provide testing to support sterilization cycle validations such as bioburden quantitation, sterilant resistance, ethylene oxide residues and microbial identifications. LexaMed has established strategic relationships with several contract laboratories and can, therefore, address a wide range of testing requirement.

Download our certifications:

.

Laboratory Testing Overview

Microbiology

        • Validation of Bioburden Method
        • Bioburden Determinations
        • Environmental Monitoring
        • Total Plate Count
        • Organism Identification
        • Microbial Limits Test, USP
        • Particulate Analysis/Microscopic Count
        • Water Testing
        • Antimicrobial Preservative Effectiveness USP
        • Disinfectant Efficacy
        • Container Closure Integrity
        • Filter Integrity

Sterility Testing

        • BI Sterility Testing, USP/ISO
        • Bacteriostasis/Fungistasis
        • Product Sterility Testing: immersion, membrane filtration, other

Sterilization Cycle Development & Validation

        • Radiation Sterilization Validation
        • EO Sterilization Development & Validation
        • Moist Heat Sterilization Development & Validation
        • VHP
        • Novel Sterilization Process Validation
        • Liquid Sterilants
        • Validation of Sterilization Processes for Reusable Devices: Steam, EO, Liquid

Biological Indicator Performance Tests

        • BI/CI Resistometer: Steam, EO
        • Label Confirmation/Certification
        • Biological Indicator Population Determination
        • Performance Verification
        • D-value – Fraction Negative
        • D-value – Survival Curve
        • z-value
        • Report Generation

Product Inoculation

        • Based on concentration and substrate

Chemistry

        • USP Physiochemical Test-Plastics
        • Wet Chemistry
        • pH Determination
        • Conductivity
        • Ethylene Oxide Residuals
        • ISO Prediction Limit
        • Limulus Amoebocyte Lysate (LAL)
        • HPLC / GC
        • Organic Body Fluid and Detergent Residuals
        • Total Organic Carbon (TOC) Analysis

In Vitro Toxicology

        • Cytotoxicity
        • Hemolysis (Screening Method)

Additional Tests and Services

        • Coordination of Sterilization Exposures
        • Coordination of Hospital Simulated Use and Maintenance of Sterility Testing/Shelf Life
        • Accelerated Aging and Shelf Life Studies
        • Customized Lab Evaluations/Tests
        • Surgical Fabric Testing
        • Cleaning Validation of Reusable Devices
        • Disinfectant Evaluation and Testing

Customized R&D and Laboratory Studies

LexaMed offers dedicated laboratory space, services and professional staff to conduct customized Research and Development evaluations and protocols. Our experienced staff can assist with defining the project and experimental approach and design, author the test protocols, execute the protocols and author the final report. We can also assist with any regulatory submissions as required. These confidential studies offer a unique, cost-effective opportunity for those companies who do not have the dedicated laboratory space or personnel resources to pursue new product or process opportunities. These studies can involve microbiology, chemistry, sterilization, biological and chemical indicators, medical device design, etc. LexaMed also has medical device manufacturing space available for prototype assembly and testing.

Assembly and Packaging

LexaMed has established strategic relationships with several companies and therefore can address a wide range of manufacturing requirements. LexaMed can provide you with a total molded product and packaging solution that includes product development, manufacturing, sterilization, testing, packaging and distribution. Our capabilities include, but are not limited to:

  • Cleaning, packaging and sterilization of manufacturing appliances and aids
  • Assembly of Medical Devices
  • Packaging – Pouch, Bag, CSR Wrap
  • Packaging Validation per AAMI / ISO
  • Package Integrity Testing
  • Seal Peel Test
  • Burst Test
  • Sterilization Validation
  • Bacterial Filtration Efficiency (BFE) per ASTM

Please contact us with your specific requirements. For more information, please download our company brochure.

Need a Quick Quote?

Please email your specific request, including name, company name, and desired time frame to info@lexamed.net.

Sample Submission Form

For routine laboratory testing, please download our Sample Submission Form below and submit it with your sample(s).