Lab Services Overview

Laboratory Routine Testing, Specific Project Testing, Client R&D, Sterilization, and Packaging:

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

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
  • Sterilization Consulting
  • VHP
  • Novel Processes
  • 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 Innoculation

  • Based on concentration and substrate

Chemistry

  • USP Physiochemical Test-Plastics
  • USP Physiochemical Test-Elastometric Closures
  • Wet Chemistry
  • pH Determination
  • Conductivity
  • Ethylene Oxide Residuals
  • ISO Prediction Limit
  • Limulus Amoebocyte Lysate (LAL)
  • HPLC / GC

In Vitro Toxicology

  • Cytotoxicity
  • Hemolysis (Screening Method)

Additional Tests and Services

Laboratory Services

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 and ethylene oxide 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. Sample Submission Form      

LexaMed has established strategic relationships with several contract laboratories and can, therefore, address a wide range of testing requirement. Specifically, LexaMed and Spectrum Plastics Group are strategically aligned to provide you with a total molded product and packaging solution that includes product development, manufacturing, sterilization, testing, packaging and distribution. LexaMed also has a working relationship with Steel Rule Diemasters (www.steel-rule-die-fda.com) to provide certified clean, packaged and sterilized dies for medical applications. Please contact us with your specific requirements.

Customized R&D and Laboratory Studies

We have laboratory space for your project.

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 or chemical indicators or medical device design, etc. LexaMed also has medical device manufacturing space available for prototype assembly and testing.

             

Please contact us to discuss your specific requirements. We are not subleasing any laboratory space at this time.

Company Brochure                    Sample Submission Form                          Fee Schedule 

 

In addition to certified laboratory services, LexaMed  also offers a full range of related consulting, validation, health care facility practice support, regulatory assistance, nutraceutical, quality system management, auditing,  environmental monitoring, quality, and training services, as well as a microbial suspension product line.

 

Assembly and Packaging

  • Assembly of Medical Devices
  • Packaging - Pouch, Bag, CSR Wrap
  • Packaging Validation per AAMI / ISO
  • Package Integrity Testing
  • Seal Peel Test
  • Burst Test
  • Sterilization Validation

    ►Radiation

    ►Moist Heat

    ►Novel

  • Bacterial Filtration Efficiency (BFE) per ASTM