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Clean room qualification by Testo Industrial Services

Safety and compliance for your cleanrooms

Qualification of cleanrooms.

Qualification

Qualification of cleanrooms

Safety and compliance for your cleanrooms

Controlled ambient conditions in production, laboratory and storage areas ensure product quality. The cleanroom qualification verifies that the ambient conditions do not affect the product quality, or have any influence is reduced to an acceptable level.

Testo Industrial Services can offer you technical and HR support for the extensive GMP measures in the field of cleanroom qualification. We carry out all qualification tests in accordance with Annex 1 of the EU GMP guidelines, DIN EN ISO 14644 and VDI 2083. In addition to cleanroom qualification, we also carry out tests and qualifications of safety cabinets, insulators and other clean air systems.
We will support you from the conception and planning of the qualification phases (DQ, IQ, OQ, PQ), the implementation of risk management in accordance with the requirements of ICH Q9/ EU-GMP guidelines through to maintenance services and re-qualification measures. In the process, we will support you with your individual measurements or take over the complete project management.

Reproducible climatic conditions are vital in the production of sensitive products in cleanrooms.
We will support you by ensuring constant temperature and humidity values in your cleanroom:
 

  • Individual measurements of temperature and relative air humidity
  • Implementation of climatic mapping in cleanroom areas
  • Definition of critical monitoring points
  • Commissioning, validation and calibration of monitoring systems

The protection of cleanroom areas against contamination from less clean areas is ensured by a differential pressure concept with controlled overpressure. By measuring the pressure and the air flow velocity, operational safety can be increased and the quality of the products ensured.
We will support you in your qualification measurements in your cleanrooms:
 

  • Verification of differential pressure cascades
  • Differential pressure measurement on the filter
Pressure measurement in clean rooms by Testo Industrial Services

Maintaining defined, cascaded overpressure chambers generates an air flow from areas of higher purity to areas of lower purity. By supplementing the pressure measurement by measuring the air flow velocity and direction of flow, operational reliability can be increased.
We will support you in your qualification measurements in your cleanrooms:

  • Determination of the incoming air volume flow
  • Calculation of the air exchange rate
  • Flow visualisation
  • Determination of the flow velocity of TAV flows

 

Flow measurements in clean rooms by Testo Industrial Services

In cleanrooms, the concentration of airborne particles is one of the decisive parameters for a suitable process environment. After qualification, particle monitoring ensures that the established air quality is maintained.
We will support you in your particle measurements in your cleanrooms:
 

  • Classification measurement/determination of the particulate purity class
  • Recovery time measurement/recovery test
  • Filter leak test/integrity test
Particle measurement in clean rooms by Testo Industrial Services

In addition to classification measurements, we carry out microbiological sampling. We will manage the entire monitoring process from planning to the final report. The limit values for this are laid down in the EU GMP Guideline, Annex 1.
Our services in the field of microbiological monitoring:
 

  • Classification measurement (microbiological)
  • Air testing (active air germ collection or sedimentation)
  • Surface testing (direct sampling/contact test)
  • Inspection of staff (in sterile areas)
  • Determination of sampling points, frequencies and action limits
  • Sampling
  • Analysis in a GMP-certified laboratory
  • Determination of total bacterial count
  • Identification of germs (up to genus or species)
  • Advice on OOS and OOT results
Microbiological monitoring in clean rooms by Testo Industrial Services

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Accreditation certificate testing laboratory - Testo Industrial Services

Highest quality standards

Accredited test laboratory

Testo Industrial Services is accredited as a test laboratory in accordance with ISO/IEC 17025 for testing in the field of qualification of cleanrooms. Testing is carried out in strict adherence to DIN EN ISO 14644, VDI 2083 and Annex 1 (EU GMP Guideline).

DAkkS has verified that Testo Industrial Services has the expertise to carry out the following cleanroom services:
 

  • Classification of air cleanliness by particle concentration
  • Flow test
  • Testing the differential pressure
  • Leak test on the installed filter system
  • Testing the direction of air flow and visualisation of the flow
  • Temperature testing
  • Humidity testing
  • Recovery time testing
  • Testing the differential pressure on the filter
Clean room qualification by Testo Industrial Serivces

More assurance, better service for your GMP compliance

What sets us apart

Expertise

Consulting, measurements, project management – our team with experience of the industry will support you precisely according to your needs

Technology

The use of our extensive test and measuring equipment with more than 4,500 references ensures reliable measurement and test results

Documentation

We will hand over the documentation to you in person upon completion of the order in audit-proven layout or customised to requirements

Qualification of cleanrooms

Our references

Know-how

Clean room

Your contact

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