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.
Cleanroom Monitoring
Cleanrooms certified/commissioned and validated to ISO 14644-1,14644-3, EU Guide and IEST-RP-CC-006.3 practices.
Cleanroom 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
Cleanroom Tests carried out:
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Microbiological Safety Devices
Microbiological Safety devices certified/commissioned and validated to EN 12469
Cleanroom Tests carried out:
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Isolators
Isolators certified/commisioned and validated to IEST-RP-CC-006.3,ISO14644-1 and EU Guide
Cleanroom Tests carried out:
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Fume Hoods
Fume Hoods certified/commissioned and validated to EN 14175
Cleanroom 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 Cleanroom Monitoring 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