&
Before a
can be used for
numerous
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
und
Everything under control
Our services in cleanrooms and areas:
Measurement of air velocity and
Measurement of
Determination of air and
Determination of the
Our services in the area of media qualification (excerpt):
With our specially developed
, we determine a wide range of parameters in technical gases, e.g.:
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.
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
YOU MIGHT ALSO BE INTERESTED IN THIS
Renewable energies
The Swiss group Meyer Burger AG has played a key role in shaping the development of the global photovoltaic industry in recent decades – at first as the supplier of production systems, and since 2021 also as the manufacturer of its high-performance photovoltaic cells and modules.
Pharmaceutical industry
Diagnostics is a subsidiary of the Swiss pharmaceutical group Roche Holding and is one of the world's leading suppliers of diagnostic systems for clinics, laboratories and doctors' practices. The company invests specifically in research and development for innovative tests/systems for the rapid and reliable diagnosis of diseases.
Hospital sector
The stem cell and immune laboratory of the University Hospital Tübingen not only supplies the hospital itself with stem cell transplants and preparations for cellular immunotherapy - the preparations go to hospitals all over the world.
Food industry
Increasing quality requirements in the food sector mean that filling plants also have to comply with ever stricter hygiene regulations. CAT Group qualifies filling plants for non-alcoholic beverages, e.g., at regular intervals for various customers in Germany and abroad.
Qualification demonstrates that rooms, facilities, and technical systems are designed, installed, and operated in accordance with defined requirements. Validation goes a step further by examining processes and procedures and demonstrating that they consistently produce the intended results.
Depending on the cleanroom and its requirements, measurements may include particle concentration, air velocity, air volume flow, pressure differentials, temperature, relative humidity, recovery time, and filter integrity. In addition, microbiological measurements and other application-specific tests may be required.
The requirements depend on the cleanroom’s intended use. Commonly relevant standards include DIN EN ISO 14644, the EU GMP Guidelines, VDI 2083, and other pharmaceutical and industry-specific regulations.
Cleanrooms must be re-evaluated at specified intervals and, if necessary, following relevant changes or modifications. The specific tests and intervals required depend on the cleanroom class, intended use, and regulatory requirements.
Yes. Existing cleanrooms can also be inspected, requalified, or re-qualified following changes. This may be necessary, for example, after renovations, technical modifications, or as part of regularly required inspections.
Yes, the CAT Group can assist with the qualification process - from developing a suitable qualification strategy to conducting the necessary measurements and preparing the documentation. We can handle both individual tests and complete qualification projects.
The CAT Group has decades of experience in the qualification and validation of cleanrooms, equipment, and technical systems. Our reference projects provide insight into various industries, cleanroom classes, and regulatory requirements.
View references for qualification & validation.
Other competences
Contact
Any questions? Simply contact us without any obligation. We will be happy to assist you with our reliable expertise.
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