Type A cleanroom for medical equipment manufacturing (low risk)
Type B cleanroom for medical equipment manufacturing (medium-low risk)
Type C cleanroom for medical equipment manufacturing (medium-high risk)
Type D cleanroom for medical equipment manufacturing (high risk)
– Have a changing room for workers to change into protective clothing before entering the production area.
– Separate packaging room arrangement.
– Have internal air conditioning (preferably).
– Before entering the room, there should be an area for hand washing and disinfecting workers’ hands before packaging products (preferably separate for the packaging room).
– Have a separate room for storing materials/supplies/chemicals.
– Have a separate, sealed warehouse for finished products.
– Have a separate area/room for storing packaging materials.
– The floor, walls, and ceiling of the packaging room should be smooth, clean, easy to clean, resistant to dirt and dust.
– The production area should be sealed, and minimize dust infiltration.
The cleanrooms for medical equipment manufacturing are classified into levels B, C, and D, which correspond to class 1,000, class 10,000, and class 100,000, respectively, depending on the requirements of the manufactured products.
