Bio-Cleanroom Aseptic Area Design Guidelines
- 2024-02-02
- View 12
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