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

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