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Technician doing a visualisation study on a safety cabinet
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Device services, Cleanroom services, GMP doc & quality assurance

Visualisation study

Brings the invisible to light

Lifecycle
Maintenance

Visualisation of air flows in clean areas as a central aspect of EU GMP Annex 1

Targeted checks ensure that air from less clean areas does not enter, thus preventing potential contamination. This measure is essential to ensure the integrity of the production environment and the quality of the products.

Field of application

Versatile application: The visualisation study is tailored for:

  • Primarily

    Safety cabinets

  • Secondary

    Fume cupboards, ceiling modules, cleanrooms and laminar flows

Benefits

Your advantages with the visualisation study

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    Contamination safety

    Airflows in cleanrooms, fume cupboards, or safety cabinets are precisely visualized to ensure that no air from less clean zones enters the critical area. This guarantees that the production environment remains clean and protected.

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    Compliance documentation

    In accordance with EU GMP Annex 1 (Section 4.15): Our studies provide video sequences and detailed reports as valid proof of proper airflow and contamination control.

  • Detailed process transparency

    The study uses targeted smoke generator visualizations and delivers video and photo documentation. This allows you to clearly see and understand airflow and particle movements, ensuring full transparency of your processes.

SKAN technican at customers site shaking hands

Frequently asked questions

  • 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.”

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

  • 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.

  • 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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Whether you have a question about our products, need technical support or would like to find out more about our solutions.

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