Measurement and qualification activities for regulated areas of production, filling, storage facilities, stability chambers, as well as on equipment such as isolators sampling cabinets and laminar flow cabins, autoclaves, etc.
How we can help?
Our experts perform initial and recurring measurements for clean room qualification:
- DEHS-Challenge Test (Filter-Leak-Test)
- Particle measurement
- Differential pressure measurement of HEPA Filter
- Velocity measurement of Laminar-Flow-Units
- Air Sampling for Cross Contamination Prevention Concept
- Particle measurements in process gases
- Temperature- humidity and pressure validation studies for initial or re-qualification on autoclaves, cooling storage rooms, climate chambers and refrigeratores
- calibration on different sensors
How do we create value for you?
The main responsibility of this team is to perform measurements. In general, the customers, operators of the mentioned plants, but also validation coordinators are supported in all topics concerning measurement and qualification:
- Determination of acceptance criteria for qualification documentation (URS, RA, OQ, PQ)
- Positioning of measurement points
- support and advice before and during audits
- support during reviews of SOPs
- Assistance in the preparation of regulations
- Investigation of causes of technical problems as well as their solution (Root Cause, CAPA's ...)