Visualisation study

Applications

Primarily safety cabinets. Also possible on fume cupboards, ceiling modules, clean rooms and laminar flow

Frequently asked questions

• What must be guaranteed according to GMP Annex 1?

  The revision of EU GMP Annex 1 focuses on the ‘Contamination Control Strategy’.
  This describes, for example, that the air flow within clean areas must be visualised.

  Extract from EU GMP Annex 1 (section 4.15):
  “Airflow patterns within cleanrooms and zones should be visualized to demonstrate that there is no ingress from lower grade areas and that air does not travel from less clean areas (such as the floor) or over operators or equipment that may transfer contamination to the higher grade areas.”

• Which smoke generators are used?

  We use smoke generators from Topas. The smoke fluid is a mixture of polyhydric alcohols and water and is vaporised.

• How does a flow visualisation work?

  We distinguish between studies and visualisations. Studies are carried out according to a ‘script’ provided by the customer and can take 3-4 hours. Visualisations, on the other hand, document the correct air flow of the displacement flow and the inlet flow. Both options are recorded on video.

• What is included in a qualification?

  During qualification, we record the correct air flow of displacement flow and inlet velocity with a video sequence of approx. 10 seconds.

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