Drug Development

Microbiology Testing and Support Services

Each DPT center of excellence is supported by a full-service, in-house microbiology laboratory. Microbiology testing and services performed by these labs include:

Microbial Limits Assay Development, Testing, and Validation

  • Microbial limit testing
  • Test method validation/suitability
  • Bioburden test validation/determination
  • Bacterial and fungal identification

Antimicrobial Effectiveness Testing

  • Minimum inhibitory concentration

Bacterial Endotoxin Testing

  • Gel clot method
  • Validation-inhibition enhancement

Isolator Sterility Testing

  • Direct inoculation or membrane filtration
  • Vaporized hydrogen peroxide sterilant
  • Bacteriostasis/fungistasis validation

Process/USP Purified Water Testing

  • Total count
  • Coliform screen
  • Pathogen screen
  • Endotoxin testing

Environmental Monitoring

  • Non-viable
  • Contact viable
  • Viable air
  • Swabbing

If you would like to learn more about our microbiology services, click "go."