We conduct microbiological testing to evaluate potential contamination sources across manufacturing systems and controlled environments. Test design accounts for production methods, material attributes, and the regulatory standards that govern each process.
We provide:
- Microbial identification using systems such as the Bruker Biotyper® MALDI-TOF and 3130XL Genetic Analyzer
- Bacterial endotoxin testing (USP <85>) to verify product and process safety
- Bioburden and sterility testing for medical devices and materials
- Microbiological support for pharmaceutical testing, including method verification and in-process controls
- Environmental monitoring and cleanroom validation for controlled environments
- Contamination response investigation, including root cause analysis, corrective action planning, and post-cleaning verification