Get More Done. Stay In Control
MICROBIOLOGY, ENVIRONMENTAL MONITORING, & PERSONNEL MONITORING

Our Expertise
At Kymanox, our risk-based approach to Microbiology, Environmental Monitoring (EM), and Personnel Monitoring (PM) ensures facilities and personnel operate in a state of control — ultimately ensuring patient safety. We understand the interaction between the manufacturing environment and the production process for life science products.
We provide expertise and support in the following areas:

- Bioburden, Endotoxin, Sterility, and Antimicrobial Effectiveness Testing (AET) Verification
- Microbiology Equipment and Lab Instrument Selection and Qualification
- Routine EM Site Selection, Justification, and EM Trend Reports
- Environmental Monitoring Performance Qualification (EMPQ)
- Out-of-Specification (OOS) and Root Cause Investigation
- Corrective and Preventative Action (CAPA) Closure
- Pre-Approval Inspection (PAI) Readiness Gap Assessment
- Disinfectant Efficacy Testing
- Rapid Sterility and Alternative Endotoxin Methods
- Growth Promotion and Media Qualification
- Sample Hold Time and Low
Endotoxin Recovery Studies
- Aseptic Processing (e.g., Media Fill) Support
- Analyst Training and Personnel Gowning
- Clean Utilities Testing
MICROBIOLOGY, ENVIRONMENTAL MONITORING, & PERSONNEL MONITORING

Our Expertise
At Kymanox, our risk-based approach to Microbiology, Environmental Monitoring (EM), and Personnel Monitoring (PM) ensures facilities and personnel operate in a state of control — ultimately ensuring patient safety. We understand the interaction between the manufacturing environment and the production process for life science products.
We provide expertise and support in the following areas:
- Bioburden, Endotoxin, Sterility, and Antimicrobial Effectiveness Testing (AET) Verification
- Microbiology Equipment and Lab Instrument Selection and Qualification
- Routine EM Site Selection, Justification, and EM Trend Reports

- Environmental Monitoring Performance Qualification (EMPQ)
- Out-of-Specification (OOS) and Root Cause Investigation
- Corrective and Preventative Action (CAPA) Closure
- Pre-Approval Inspection (PAI) Readiness Gap Assessment
- Disinfectant Efficacy Testing
- Rapid Sterility and Alternative Endotoxin Methods
- Growth Promotion and Media Qualification
- Sample Hold Time and Low Endotoxin Recovery Studies
- Aseptic Processing (e.g., Media Fill) Support
- Analyst Training and Personnel Gowning
- Clean Utilities Testing

Synergy with Key Kymanox Services
Kymanox has scientific, technical, and regulatory expertise to ensure client projects are done Right First Time. Kymanox holds a 360º view of all quality monitoring services and support these services with the following additional capabilities:
- Quality Assurance, Quality Control, and Global Auditing
- Chemistry, Manufacturing, and Controls (CMC) and Analytical Services
- Turnkey Program and Project Management
- Regulatory Affairs
- Commissioning, Qualification, and Validation
- Training

Synergy with Key Kymanox Services
Kymanox has scientific, technical, and regulatory expertise to ensure client projects are done Right First Time. Kymanox holds a 360º view of all quality monitoring services and support these services with the following additional capabilities:
- Quality Assurance, Quality Control, and Global Auditing
- Chemistry, Manufacturing, and Controls (CMC) and Analytical Services
- Turnkey Program and Project Management
- Regulatory Affairs
- Commissioning, Qualification, and Validation
- Training
Your Life Science Solutions Partner For Staying In Control
Your Life Science Solutions Partner For Staying In Control