Qualification
&
validation
Before a
cleanroom
can be used for
production,
numerous
acceptance measurements
are necessary. This way, proof is provided to customers and authorities that the specifications and acceptance limits of the respective required standards and customer requirements have been met.
We execute these measurements reliably – in accordance with
EU-GMP,
DIN EN ISO 14644,
FDA,
VDI 2083
und
DIN EN ISO 8573.
Everything under control
Our services in cleanrooms and areas:
- Testing of terminal filters as well as filters installed in systems and devices
-
Measurement of air velocity and
air flow rate
-
Measurement of
pressure difference
- Measurement of temperature and humidity
- Measurement of recovery time and clean-up phase
- Measurement of sound pressure level and illuminance
-
Determination of air and
bacterial counts on surfaces
-
Determination of the
air purity class
Our services in the area of media qualification (excerpt):
With our specially developed
measuring systems
, we determine a wide range of parameters in technical gases, e.g.:
-
Particle concentration
-
Microbial count of airborne microorganisms
- Pressure dew point
- Residual oil content
- Residual oxygen content
But we do not limit ourselves to measurements alone. Because it goes without saying that we get to the bottom of any deviations, analyze the causes and search for optimization and solutions – by constantly communicating with you and utilizing our many years of experience.
Validation
The requirements for the quality of filtered air for sensitive production and work areas, as well as the highly specialized technology required for this purpose, are becoming increasingly stringent. With our holistic approach, which we apply long before actual production, we ensure highest production reliability. Because this way, we provide proof that the rooms, facilities and processes used for production and quality control are suitable for their intended purpose.
From consulting to the development and completion of individual qualifications according to the V model of validation – we support you to the fullest extent possible. Jointly defining a qualification strategy is just as much a part of our tasks as is creating a clear qualification structure with the individual documentation steps.
Our services (excerpt):
Validation of
- Air systems
- Cleanrooms
- Ultrapure water systems
-
Production facilities
- Gases
- Compressed air systems
- Process systems
Other competences
Consulting & planning 
Qualification & validation 
Calibration 
Flow visualization 
Cleanroom equipment and stainless steel products 
Site management & construction management 
Commissioning 
Electrical building services 
Heating | Cooling | Ventilation | Sanitary 
Maintenance | Repair | Service