Cleanroom Qualification

Our new service: requalification of cleanrooms according to GMP and ISO

We offer you professional support with all GMP and ISO 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 support you in creating or reviewing your requalification plan in accordance with current standards and guidelines. We also carry out measurements in your cleanroom and create detailed documentation for both internal and external audits.

We are always available to answer any questions you may have about requalifying your cleanroom. With us, you have a partner at your side who, in addition to servicing safety cabinets and isolators, also looks after all aspects of your cleanroom area.

Together, we will achieve a high level of quality and performance to ensure a safe working environment.

Our portfolio:

• Creation/testing of requalification plans in accordance with ISO or GMP
• Visual inspection of the room closing surfaces
• Volume flow measurement and determination of the
• air exchange rate
• Temperature and relative humidity measurements
• Room differential pressure measurements (positive and negative pressure)
• Filter integrity test in accordance with DIN EN ISO 14644-3
• Determination of cleanroom class in accordance with DIN 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
• In-place calibration of display devices and sensors
• Flow visualization
• Filter change
• Detailed documentation for high transparency and basis for external and internal audits
• Adaptation of measuring point plans and additional room diagrams