Qualification / Validation of Clean Rooms
We provide comprehensive qualification and validation of clean rooms, laminar boxes, and compressed air systems according to international standards ISO 14644 and EU GMP.
Qualification confirms that the clean room and its equipment function correctly and according to specifications. It covers all critical phases:
- DQ – Design Qualification: verification that the room design meets client requirements and standards, ready for equipment installation
- IQ – Installation Qualification: inspection and documentation of proper installation of all systems, including ventilation, filtration, and instruments
- OQ – Operational Qualification: testing operational parameters such as airflow, pressure ratios, temperature, and humidity etc.
- PQ – Performance Qualification: verification that the room can consistently meet performance parameters during regular operation
Validation confirms that the clean room is suitable for intended use and meets all critical parameters for safe and efficient operation. Ensures that processes, equipment, and environment comply with expected cleanliness and quality levels, minimizing contamination risk and supporting reliable production or research.
We provide comprehensive inspection of clean rooms and healthcare areas, including operating theatres and sterilization units. Our services include:
- Visual inspection of environmental conditions
- Airborne particle measurement
- Airflow, air velocity and air change rate verification
- Differential pressure control
- Temperature and relative humidity control
- Leak test on the installed filter system
- Recovery time verification
We also perform professional inspection of clean rooms and HVAC systems:
- Clean room inspection ISO classes 8 to 5 according to ISO 14644
- GMP grade D to A clean room inspection
- Verification of physical parameters and hygiene in healthcare areas, operating rooms, and central sterilization units
- Hygienic inspection of HVAC systems
- Microbiological testing according to EU GMP based on ISO 8573-1:2010 and EN 17141:2020.
- Determination of airborne microorganisms using the impact method.
- Determination of airborne microorganisms using the sedimentation method.
- Surface microbiological examination using the imprint method.
- Compressed air inspection according to ISO 8573-1:2010 (particles, water, oil content, microorganism count).
Are you interested in our services or have any questions? Do not hesitate to contact us; we will gladly provide all necessary information.
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