Medical Device – Qualification of cleanrooms/facilities

Qualification of cleanrooms and related facilities/environmental monitoring must (depending on the classification) be carried out to secure an appropriate hygienic level in areas that are used for handling, production and testing off Medical Devices and to verify that all activities are carried out under controlled conditions.

AL Engineering is highly specialized within qualification of cleanrooms and related facilities. We therefore offer support on the following tasks. This is:

  • Planning and project management
  • Design of cleanrooms
  • Risk assessments
  • Validation documentation
    • Protocols
    • Reports
  • Trend reports and reporting

Contact

Please contact Tina Linders for a non-committal talk about how we can make a difference for your company.

+45 2913 2445