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MICROBIOLOGY, ENVIRONMENTAL MONITORING, & PERSONNEL MONITORING


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.

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:



petri dish
  • 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


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.

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

    petri dish
    • 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

          Biotechnology | Pharmaceuticals | Medical Devices | Combination Products