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Bio-Cleanroom Aseptic Area Design Guidelines

  • 2024-02-02
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Bio-Cleanroom Design Guidelines should support the process contained within the cleanroom While a rectangular shape is easiest to accommodate, other shapes may be incorporated into the facility as long as appropriate attention is paid to airflow patterns. The facility should be able to accommodate movement of equipment, material and personnel into and out of the cleanroom. The layout of the clean suite should facilitate maintaining cleanliness class, pressure differentials, and temperature/humidity conditions by isolating critical spaces and by excluding non-clean operations.


Bio-Cleanroom Aseptic Area Design Guidelines

1.Secure lockers for clothing and personal property

2.Shoe cleaner, with rotating brushes to remove gross contaminants

3.Walk-off adhesive Sticky mat

4.Air Shower, with HEPA filtered air jets to remove loose contaminants

5.Hand washing station, no-touch operation

6.Hand dryer (if not incorporated into washer), HEPA/ULPA-filtered air, no touch

7.Glove dispenser for glove liner or underglove

8.Glove washing/drying station (if gloves not clean)

9.Glove washing/drying station (if gloves not clean)

10.Headwear dispenser

11.Face mask dispenser

12.Waste receptacle—should be installed wherever packaging is removed

13.Garment Storage Facility—depends on garment type

    a.Open garment rack for reusable garments

    b.Enclosed garment cabinet for reusable garments (includes HEPA blower)

    c.Garment storage shelves for packaged disposable garments, Overstock Cabinet

    d.Cleanroom table for organization

14.Waste receptacle

15.Ergonomic lean rails support personnel while donning coveralls

16.Gowning platform provides a noncontaminated surface to prevent violation of garment

17.Wiper dispenser—used to clean bench prior to putting on booties

18.Bootie rack and shoe cover dispenser (may also be incorporated into benches)

19.Waste Receptacle

20.Gowning benches, used when putting on booties. Booties stay on "clean" side

21.Cleanroom mirror for final self-inspection (side-by-side w/poster showing correctly garbed model)

22.Safety glass dispenser and overglove dispensers

23.Air shower—may be required in cleanroom entrance

24.Garment hamper for reusable garments to be laundered

25.Waste receptacle for disposable garments

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