Regulatory Open Forum

 View Only

  • 1.  clean room

    Posted 17-Sep-2021 03:32
    Hello to all,

    Hope you all are doing great!

    I wanted to know about the cross over bench does it is required in medical device industry(dental aligners)? as the change room must to be requirements.

    Thank you in advance
    Regards


    ------------------------------
    Shivani Chawda
    Quality Assurance Executive
    ------------------------------


  • 2.  RE: clean room

    Posted 19-Sep-2021 07:51
    Hello Shivani,

    It is pretty common in a gowning room, pre-entry room, ante room, etc., to include a cross-over bench.  This just helps to create a more physical barrier so people remember the sequence of gowning up for the clean room.  Though I have been in my places which just have an indicator or marker on the wall/floor for when gowning should be in place or removed.

    ------------------------------
    Richard Vincins RAC
    Vice President Global Regulatory Affairs
    ------------------------------

    Original Message


  • 3.  RE: clean room

    Posted 19-Sep-2021 08:31
    The cross over benches (also referred as step over bench or swing over bench) serves multiple reasons - first of all it serves as a physical barrier to prevent any accidental stepping into 'cleaner' area; and also provide a comfortable sitting area for the personnel either to don the shoe covers or company-provided footwear.

    ------------------------------
    Ajit Basrur
    Worcester MA
    United States
    ------------------------------

    Original Message


  • 4.  RE: clean room

    Posted 20-Sep-2021 05:17
    In line with Richard and Ajit, if your changing room separates a clean area from a dirtier area, a line of demarcation is required. The bench, when placed and clearly marked for this purpose, will do. Although any clearly posted line of demarcation will suffice, it is my experience a bench is necessary to aid the operator gown safely. If you decide to use a bench it should be made of an easy-to-clean material and rust-resistant.

    ------------------------------
    Rolando Garcia
    Vega Alta PR
    United States
    ------------------------------

    Original Message


  • 5.  RE: clean room

    Posted 20-Sep-2021 07:58
    Dear All,

    Thank you so much for the replies as per the understanding is the dimension of 55cm height and 35cm breath is adequate for the bench?

    regards
    Shivani

    ------------------------------
    Shivani Chawda
    Quality Assurance Executive
    ------------------------------

    Original Message


  • 6.  RE: clean room

    Posted 20-Sep-2021 09:12
    Usually 18 inches high. Length should be commensurate with the dimensions of the room and your process. I find 16 inches wide provides better stability when sitting.
    From VWR:

    Length

    Width

    Supplier No.

    VWR Catalog Number

    36"

    16"

    GB1636S

    19766-776

    48"

    16"

    GB1648S

    19766-778

    60"

    16"

    GB1660S

    19766-780

    72"

    16"

    GB1672S

    19766-782


    ------------------------------
    Rolando Garcia
    Vega Alta PR
    United States
    ------------------------------

    Original Message


Related Content