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Microbiology Testing

PPD's cGMP lab provides a full range of microbiological testing. All testing is performed under cGMP requirements and complies with applicable compendia (USP/EP/JP) requirements. We also accommodate specialty testing and projects of various sizes to suit a particular need.  PPD’s state-of-the-art facility includes a 5,000-square foot HEPA filtered, restricted access microbiology lab with a separate ISO Class 8 sterility suite.

Microbiology testing services include:

  • Endotoxin testing (kinetic turbidimetric, chromogenic and gel clot)
  • Microbial limits testing (complies with USP <61><62>)
  • Bioburden testing
  • Water testing
  • Antimicrobial effectiveness (complies with USP <51>)
  • Antibiotic potency assay (per USP <81> or develop method)
  • Container closure integrity testing
  • Environmental monitoring (on-site testing, incubation and reading)
  • Media-fill support
  • BI sterility
  • Sterility testing (performed in an isolator per USP <71>)
  • Disinfectant efficacy testing
  • Minimum inhibitory concentration (MIC)

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