EMS provide a complete Cleanroom certification service adhering to ISO and GMP industrial standards. All tests carried out by trained, responsible, competent and flexible staff working to documented test procedures.
Cleanrooms Monitoring
Clean-rooms certified/comissioned and validated to ISO 14644-1,14644-3,EU Guide and IEST-RP-CC-006.3 practices.
Tests carried out:
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Unidirectional Airflow Devices (LAFs)
Unidirectional airflow devices certified/commissioned and validated to IEST-RP-CC-002.2,EU Guide and
ISO 14644-1
Tests carried out:
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Microbiological Safety Devices
Microbiological Safety devices certified/commissioned and validated to EN 12469
Tests carried out:
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Isolators
Isolators certified/commisioned and validated to IEST-RP-CC-006.3,ISO14644-1 and EU Guide
Tests carried out:
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Fume Hoods
Fume Hoods certified/commissioned and validated to EN 14175
Tests carried out:
- Inward Velocity
- Visualisation
- Alarm Verification
Operating Theaters
Operating Theatres certified/commissioned and validated to IEST-RP-CC-002.2,EU Guide and ISO 14644-1
Tests carried out:
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Compressed Air/Nitrogen
The following are some of the clean-room tests we perform:
- Hepa Filter Leak Test
- Airborne Particle Count
- Air Change Rates
- Pressure Profiles
- Velocities
- Visualisation
- Recoveries
- Temp/Humidity
All tests carried out by trained, responsible, competent and flexible staff working to documented test procedures.
- ISO14644-1
- EU GUIDE TO GMP
ANNEX 1 - ISO 14644-3
- IEST-RP-CC006.3
- EN12469
- IEST-RP-CC002.2
- IEST-RP-CC034.2
- EN 141755
