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.
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)