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+49 711 36591990
E-Mail
info@catgmbh.de

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

Contact

Any questions? Simply contact us without any obligation. We will be happy to assist you with our reliable expertise.

  • CAT GROUP:
    CAT Clean Air Technology GmbH
    Motorstr. 51 | 70499 Stuttgart
    CAT e-tec GmbH
    Motorstr. 51 | 70499 Stuttgart
    CAT m-tec GmbH
    Motorstr. 51 | 70499 Stuttgart
  • info@catgmbh.de
  • Tel: +49 711 3659199 – 0
    Fax: +49 711 3659199 – 99

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