Testing Services - Microbiology

 LABS performs over 400 tests, so if you don't see what you need in the list below, please contact our Sales department (877-522-7088) for more information.

General Microbiology Testing


Pre-processing, In-process and Post-process

  • Bioburden testing
  • Environmental monitoring
  • Purified water Cultures
  • Blood and Platelet Cultures
  • Bacterial and yeast identification to species
  • Fungal identification to genus
  • VRE, MRSA, and Sensitivity Testing (CLSI Standards)
  • Sputum, Urine, and Perfusate Cultures
  • Biological Indicator (Spore Strip) Testing

Product Specific Microbiology Tests

  • Sterility USP <71>
  • Bioburden Recovery Validations
  • Recovery Cultures
  • Method Suitability USP <71>
  • Radiation Sterilization Validation
  • Radiation Sterilization Dose Audits
  • Residual Moisture
  • Method Development and Validation

 

Compendial Methods/Standards and Guidelines Used to Support LABS Test Methods

Radiation Sterilization
USP Chapters:

  • <1035> Biological Indicators for Sterilization
  • <1211> Sterilization and Sterility Assurance of Compendial Articles
  • ISO 11137 Radiation Sterilization Parts 1, 2 and 3

Microbial/Sterility Issues
USP Chapters:

  • <61> Microbial Enumeration-NonSterile Products
  • <71> Sterility Tests
  • <1211> Sterilization and Sterility Assurance of Compendial Articles

Steam Sterilization

  • ISO 17655 Moist Heat (Steam Sterilization)

Sterilization of Human Tissue

  • AAMI TIR 37 Guidance for radiation sterilization of Human Tissue

Cleanroom and Environmental Monitoring
USP Chapters:

  • <1116> Microbiological Evaluation of Cleanrooms
  • ISO 14644 Cleanrooms and Associated Controlled Environments Parts 1 – 7
     

 Microbial Recovery (Bioburden) Validation
USP Chapters:

  • <1227> Validation of Microbial Recovery
  • ISO 11737 Bioburden Testing

Other
USP Chapters:

  • <1072> Disinfectants and Antiseptics
  • <1117> Microbiological Best Laboratory Practices
  • <1223> Validation of Alternative Microbiological Methods

Clinical Laboratory Standards Institute

  • M02 Antimicrobial Disk Susceptibility Testing
  • M35 Identification of Yeast and Bacteria
  • M100 Performance Standards - Antimicrobial Susceptibility