Validation

  • Validation & commissioning

Validation & commissioning

ABN Cleanroom Technology helps you to verify if your cleanrooms, production rooms and operating theaters meet international regulations (EU, FDA, ISO) or GMP requirements.

We always set up a detailed program for the periodic monitoring or (re) qualification of your cleanrooms.

commissioning1Following components are part of it:

  • air volumes
  • pressure differences
  • filter integrity (DOP test)
  • velocities
  • particle classification
  • microbiological sampling
  • air flow patterns: visualization and registration
  • recovery
  • temperature
  • relative humidity
  • light
  • sound

Advanced measuring equipment

On the basis of a pre-approved protocol, we analyze whether your cleanroom complies with the acceptance criteria. After the measurement, the final report is discussed. If needed, this is done in consultation with the responsible services or suppliers. In addition to the results of the measurements, the report also includes recommendations to address any comments or deviations.

Overview validation classifications

cleanroom classification and validation

Cleanroom filter test-methods

cleanroom filter tests

Examples

 

Vraag het onze specialisten

Graag laten wij u kennis met ABN's cleanroom technologie. Geniet van advies op maat door een van onze specialisten.

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