When starting up a new manufacturing area, the qualification of systems that support the drug production process (facilities, utilities, and equipment) is essential to ensure patient safety and product quality, and to meet regulatory requirements and business needs.  Qualification must be done quickly and correctly so the area can be used for production. In the life science industry, missing one day of production could mean major losses in product and opportunity costs.

Qualifying a new facility is a huge undertaking, and current employees may not have the time or knowledge needed to properly qualify the facility.  Kymanox has the expertise and experience to qualify a wide range of systems, including:

  • Cleanrooms
  • Clean utilities (e.g., nitrogen, compressed air, purified water, clean steam, HVAC)
  • Aseptic manufacturing equipment (e.g., sterilization, formulation & filling, lyophilization)
  • Custom manufacturing equipment and control systems
  • Drug product packaging equipment
  • Controlled storage equipment and facilities (e.g., refrigerators, freezers, incubators, warehouses)
  • Computerized software systems

We have successfully qualified these types of systems and more for a broad range of clients, from small start-ups entering clinical trials to Fortune 500 commercial manufacturers.

Kymanox ensures efficient and successful qualification by providing engineering and regulatory resources and using an integrated team approach.  System owners and quality units from the client are involved early in qualification planning to ensure that an appropriate level of testing is decided and executed, and that all documentation meets regulatory expectations.  Using a combination of traditional validation methods and risk-based strategies, Kymanox works with each client to ensure robust qualification packages.