Regulatory Open Forum

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  • 1.  medical devices

    Posted 03-Sep-2021 08:18
    Hi, can static pass box can be use for bidirectional flow of material in case of dental model and aligner sheet? 
    Thanks

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    Shivani Chawda
    Quality Assurance Executive
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  • 2.  RE: medical devices

    Posted 04-Sep-2021 09:13
    A key concern in the application of pass-throughs is the risk of contaminating a clean space by the opening of a
    pass-through to a less clean space. In this case, a "static" process would not be adequate. Depending on your facility's design passive ventilation could be an option.

    Passive Ventilation: Utilizes the pressure relationship between rooms, the airflow within rooms, and the
    opening and closing of pass-through doors to provide airflow as the motive force to transfer particles into, or
    out of, these boxes. Engineered leak paths can be fitted to passively ventilated pass-through boxes to allow
    room pressure difference to ventilate the box with sufficient volume to dilute internal contaminants. These
    defined leak paths may be unrestricted or filtered openings. More commonly, pass-through boxes are near
    airtight which reduces the passive ventilation to a minimal amount.

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    Rolando Garcia

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