Cleanroom Qualification

New! Berner cleanroom requalification

Berner offers you professional support for all GMP measures in the area of cleanroom requalification.

By complying with the requirements of EU GMP Annex 1 & EC guidelines, VDI 2083, ISO 14644 and DIN 1946-4, we ensure that your facilities meet the highest standards. We accompany you from the creation or review of the requalification plan for currently valid standards and guidelines to measurements in your cleanroom and detailed documentation for both external and internal audits.

In addition, we are always on hand to answer any questions you may have regarding the requalification of your cleanroom. With Berner, you have a partner at your side who not only offers you service via Berner safety cabinets, but also covers the entire cleanroom sector. Everything from a single source. 




Contact us!

Telefon+49 4121-43560






Our portfolio:

  • Creation/testing of requalification plans in accordance with ISO or GMP
  • Visual inspection of the room enclosure surfaces
  • Volume flow rate measurements and air change rate determinations
  • Temperature and relative humidity measurements
  • Room differential pressure measurements (positive pressure and negative pressure)
  • Filter integrity test (DEHS test)
  • Determination of cleanroom class in accordance with EN ISO 14644-1, GMP/EC guidelines and VDI 2083, Sheet 1
  • Recovery time measurements 100:1/10:1/clean-up phase
  • Sound level measurements
  • Illuminance measurements
  • KI-Diskus
  • In-place calibration of display units and sensors
  • Flow visualisation
  • Filter change
  • Detailed documentation for high transparency and basis for external and internal audits.


Fields of activity:

  • Laboratories
  • Pharmaceutical industry
  • Manufacturing pharmacies
  • Microelectronics and semiconductor industry
  • Medical technology
  • biotechnology
  • Drying rooms
  • Optics and precision mechanics












Your benefit:

  • One contact for workbenches and requalification
  • Reduction in organisation and downtimes, as workbenches and cleanroom requalification are carried out together.
  • Highly qualified service technicians 
  • Customised requalification plans
  • Compliance with all relevant standards and specifications for your process 
  • Thorough and precise measurements
  • All-round support from planning to implementation and documentation
  • Complete and traceable documentation