Laboratory Services

We offer hundreds of Microbiology and Chemistry tests performed by highly educated and trained technical staff.  Examples of what we offer are as follows:
Microbiology Assays
  • USP and ISO compliant Product and ISO compliant Sterility Testing and Method Validation performed in a Class 5 Cleanroom
  • USP and ISO compliant Bioburden Determination and Method Validation
  • USP Chapter <55> Biological Population Verification and D-value Determination
  • USP and ISO compliant Endotoxin Determination, Kinetic and Gel-Clot Method
  • USP Chapter <61> and <62> Microbial Limits
  • USP Chapter <55> AET
  • Microorganism Identification – Biolog
  • Filter Validation of Sterilization Filers – PDA Method
  • ISO and USP Cytotoxicity Assays
  • USP Particulate Matter Determination
  • Environmental Monitoring Plate Incubation and Enumeration
Chemistry Assays
  • Ethylene Oxide Residuals Analysis
  • USP Probalistic Container Closure Integrity (CCI) – Tracer Method
  • USP monograph testing such as Sodium Assay, Chloride Assay, Iron Assay
  • UV Analysis for Protein, Hemoglobin and Carbohydrate
  • TOC Analysis
  • USP Water Analysis including Conductivity, pH, TOC, Oxidizable Substances
  • PB70 Gown Testing – AATCC 27 and AATCC 127 analysis
Special Studies

 Listed below is an example of just some of the studies we conduct under protocol, we are continually developing new studies based on client’s needs.

  • Microbial Stability Study (MSS) of reconstituted drug products
  • Disinfectant Efficacy Study for Manufacturing Site Disinfectants
  • Cleaning and Disinfectant Validations for Reusable Devices
  • Cleaning and Disinfection Validations for Heater Cooler Systems
  • Accelerated Aging Programs for Shelf-life determination
  • Sterilant Penetration Studies
  • Microbial Aerosol Challenge Studies
  • Sterilization Cycle Development   
  • Sterilization Cycle Validation
  • Stability Testing of Pharmaceuticals
Packaging Services

LexaMed offers packaging services for Class 1 Medical Devices in our controlled environment assembly and packaging suite of rooms.  We can perform small scale assembly and packaging of devices into pouches with the seal of validated and calibrated Band and Bar Sealers.  Activities are performed in a clean environment which is monitored as part of our laboratory environmental monitoring program.   Batch records a Certificate Of Processing are generated, reviewed and approved by Quality Assurance for each lot produced.  

This function is supported with the performance of the following package performance tests:

  • ASTM Dye Penetration
  • ASTM Burst Test
  • ASTM Seal Peel Evaluation

If you would like to discuss your project with one of our experts, please fill out our contact form, and we will be with you immediately.