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Cleanroom Qualification

We qualify your cleanroom and provide complete, GMP compliant documentation.
As a TUV certified company, we offer extensive and high-quality qualifications of all cleanroom technical appliances and equipment in accordance with all established guidelines.
Our qualified and experienced technicians and engineers work with state-of-the-art and calibrated measuring equipment and realise all phases of cleanroom qualification. All measurements are carried out in a predefined operating condition (“at rest” or “in operation”) and are documented consistently and professionally, based entirely on preassigned approved inspection protocols. The results will then be evaluated using a specific report.

Afterwards, you will receive a clear, complete, comprehensive and standard-compliant documentation - of course also GMP compliant using validated test plans.

We offer:

Certified according to DIN EN ISO 9001

TÜV certified quality management system

according to DIN EN ISO 9001: 2008

cleanroom qualifications

Comprehensive and high-quality qualification services

of cleanroom equipment and systems in accordance with all standard guidelines, in the scope of DQ, IQ, OQ, PQ

Dokumentation of Cleanrooms

Comprehensive and professional documentation

in accordance with the EC GMP Guideline, DIN EN ISO 14644 or VDI 2083

cleanroom training

Support by

regularly trained, qualified and experienced technicians and engineers

Quaification of compressed air

Quaification of compressed air

Prozessvalidation

Prozessvalidation

Smoke studies

Smoke studies

visualization of product and personal protection

Illuminance

Illuminance

Cleanroom class determination

Cleanroom class determination

according DIN EN ISO 14644 or EG-GMP-Guideline

Filter integrity test

Filter integrity test

Determination of bacterial count

Determination of bacterial count

Airborne bacteria and Surface bacteria

Hygiene inspection according to VDI 6022

Hygiene inspection according to VDI 6022

Calibration of sensors

Calibration of sensors

for air flow, differential pressure, tepmerature, humidity

Measurement of air volume flow

Measurement of air volume flow

Recovery test

Recovery test

Dust quantity measurement

Dust quantity measurement

Room differential pressure

Room differential pressure

In collaboration with our customers, we determine which legal standards and specifications respectively apply in relation to the process and product.

We offer cleanroom qualifications, among others:

  • ISO 14644
  • VDI 2083
  • EC-GMP-Guideline
  • PIC/S
  • VDMA 24186
  • ISO 8573
  • VDMA 15390

 

Take advantage of our extensive experience and expertise

As a partner in consulting, planning and execution, we offer you the complete and fully documented qualification of your cleanroom systems from the first to the last step.

Please contact us. We are pleased to advise you.

The phases of a cleanroom qualification

The aim of a cleanroom qualification is to verify the requirements of the environmental conditions that are necessary from a manufacturing point of view. A cleanroom qualification is an elementary component of quality assurance.

 

Qualification Master Plan (QMP)

Document that documents the procedure throughout the qualification

 

Failure Mode and Effects Analysis (FMEA)

Conducting a risk analysis.

 

Design Qualification (DQ)

This is actually the first qualification phase for checking the planning documents for conformity with the requirements of the operator (specifications) as well as the official requirements and guidelines.

 

Installation Qualification (IQ)

This phase is used to review and define the requirements and acceptance criteria for installing a plant.

 

Operational Qualification (OQ)

The OQ uses different measurements to verify that the installed equipment meets the requirements for the previously defined parameters. All measurements are carried out "at rest".

We carry out the following measurements in the context of Operational Qualification (OQ):

  • Air flow velocity

  • Determination of the air change rate

  • Determination of the air flow volume

  • Measuring the room differential pressure

  • Filter integrity test

  • Measuring the filter differential pressure

  • Determination of the purity class

  • Recovery test

  • Measuring the temperature and humidity

  • Microbiological tests and determination of the bacteria count

Performance Qualification (PQ)

The PQ provides the documented proof that the plant or the device is producing under defined production parameters within specified parameters. All measurements are performed "in operation".