LexaMed Laboratories 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.

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Please email your specific request, including name, company name, and desired time frame to LexaMed’s team of experts at sales@lexamed.net.

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Sterility, USP <71>

Biological Indicator Sterility Testing, USP/ISO


(All products should be initially validated with a B/F test, which is also a USP requirement)

  • USP – SCD and FTM (6 Organisms)
  • AAMI/ISO – SCD only (3 Organisms)

Product Sterility Testing

Product Immersion Testing

  • <200 mL media
  • 200-500 mL media
  • 600-900 mL media

Membrane Filtration

Media Fill Sterility

Bioburden, ISO 11731

Bioburden testing determines the total number of microorganisms on or in your pharmaceutical product, components, or medical devices that have not been sterilized.  Bioburden testing can be conducted in part with a sterilization plan.  LexaMed conducts bioburden testing in accordance to ISO 11731-1.

Validation of Bioburden Method

  • Exhaustive Recovery
  • Spore Inoculation and Recovery

Bioburden Determinations (Standard Plate Count or Membrane Filtration Available):

  • Total Aerobic
  • Total Aerobic and Spores
  • Total Aerobic and Anaerobic
  • Total Aerobic and Fungi
  • Total Aerobic, Anaerobic, and Spores
  • Total Aerobic, Spores, and Fungi
  • Total Arobic, Anaerobic, Spores, and Fungi

USP Chapter <61/62>

USP Chapter <61> Microbiological Examination of non-sterile products: Microbial Enumeration Tests and USP Chapter <62> Microbial Examination of Non-Sterile Products: Test for Specified microorganisms (Previously known as USP Microbial Limits)

System Suitability:

  • System Suitability, 1 organism
  • System Suitability, 2 organisms
  • System Suitability, 3 organisms
  • System Suitability, 4 organisms
  • System Suitability, 5 organisms
  • System Suitability, 6 organisms
  • System Suitability, 7 organisms

Routine Screening:

  • Routine Screening with Total Plate Count, 1 organism
  • Routine Screening with Total Plate Count, 2 organisms
  • Routine Screening with Total Plate Count, 3 organisms
  • Routine Screening with Total Plate Count, 4 organisms
  • Routine Screening with Total Plate Count, 5 organisms
  • Routine Screening with Total Plate Count, 6 organisms
  • Routine Screening with Total Plate Count, 7 organisms

Antimicrobial Effectiveness Test

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

Environmental Monitoring

Viable and/or non-viable monitoring at your site. LexaMed can provide the equipment for you to sample at your site. Plates and/or swabs will be incubated, enumerated, and a final report will be published.  For more information please visit our environmental monitoring webpage

Product Inoculation

Total Plate Count

Water Testing

Filter Integrity

Organism ID

Antimicrobial Preservative Effectiveness, USP

Barrier Material Testing

Surgical Drapes and Gowns

Package Testing

Particulate Analysis