At NNE, we offer cleanroom test and validation support to make sure that your cleanroom is inspection-ready. Applying more than 25 years of experience, we offer a range of services, such as:
- Training in aseptic handling in a real-life environment at NNE’s premises in Virum, Denmark
- Preparation of protocols, test plans and test forms
- Test execution, conclusion and cGMP-compliant test documentation
- Advice and guidance concerning current local and international regulatory requirements
- Training in general cleanroom technology
- Smoke study, visualization and video recording
Always according to industry standards
Testing and validation of cleanroom ventilation is one of the most critical parameters in ensuring GMP compliance. Most pharma companies find it challenging to achieve the expected particle classification grade. Our team performs the tests listed below using equipment calibrated according to industry standards (ISO 14644-3):
- Measurement and analysis of airflow velocity and volumes in cleanrooms
- Calculation of room air changes
- Measurement and analysis of room pressure differential
- HEPA / ULPA filter leak test
- Non-viable airborne particulate counts for room classification
- Airflow pattern test/smoke visualization and video recording
- Room recovery test
- Test of unidirectional flow units (LAF)
- Test of c-RABS (gloveboxes), isolators, cleanbenches and work stations, biosafety cabinets, fume hoods and vacuum cleaners
- Factory acceptance tests (FAT)
- Site acceptance tests (SAT)
The only cleanroom service provider you need
With more than 15 cleanroom testers in-house, NNE is a one-stop shop for cleanroom testing services. Every year, we execute more than 300 projects and perform more than 28,000 test hours related to HVAC cleanroom testing and qualification worldwide.
Our cleanroom engineers work closely with other engineering disciplines to make sure that you get a solution that fits into the context of the rest of your facility, from building shell to automation system.
NNE is your guarantee that all regulatory requirements are met. We have been examined and accredited by the American National Environmental Balancing Bureau (NEBB) and R3 Nordic for cleanroom testing.