Facility and Utility Engineering

Kymanox experts collaborate with clients to define requirements and develop customized plans for the design and implementation of Facilities and Utilities. Our team works closely with our clients and their vendors to develop specifications, assess & develop plans for suitability and compliance with cGMP and Annex 1 requirements, and more. Our goal is to help ensure a robust infrastructure to support manufacturing operations.

Skilled services in the following:

  • Site Evaluation and Needs
  • Specifications
  • Assessment of Regulations
  • Collaboration
  • Project Management
  • Facilities & Utility Capabilities

    Kymanox has the expertise and experience to qualify a wide range of facilities and utilities, including: cleanrooms, clean utilities, Aseptic manufacturing equipment, custom manufacturing equipment and control systems, drug product packaging equipment, controlled storage equipment and facilities, computerized software systems, building management systems (BMS), and environmental monitoring systems (EMS).
    01

    End-to-End Experience

    We are involved from early stages of design and construction to align with all groups and trades to ensure seamless transition from engineering turnover through commissioning, qualification, and into production.
    02

    Robust Qualification Packages

    Using a combination of traditional validation methods and risk-based strategies, Kymanox works with each client to ensure robust qualification packages.
    03

    Partnership Model

    We partner with client system owners and quality teams in qualification planning to ensure an appropriate level of testing is decided and executed, and that all documentation meets regulatory expectations.
    04

    Integrated Approach with a Project Management Focus

    Kymanox ensures efficient and successful qualification by providing engineering and regulatory resources while using an integrated team approach, including project management.

    Voice of the Customer

    "We went with Kymanox because of their experience and knowledge."
    DIRECTOR OF DEVICE ENGINEERING
    GLOBAL BIOPHARMACEUTICAL COMPANY
    "They understand my needs."
    DIRECTOR OF VALIDATION
    PHARMACEUTICAL COMPANY
    “Kymanox has continuously stepped in to provide the expertise that we have needed exactly when we need it”
    DIRECTOR, QUALITY CONTROL
    BIOTECH COMPANY