Proper gowning is one of the first lines of protection against contaminants and dust in your cleanroom, that could lead to a major defects in your cleanroom.
Setting up a proper gowning process depends on what type of cleanroom or process is conducted in the room and its ISO classification (ie. Semiconductor, electronics, pharmaceutical, etc).
Semiconductor Facilities may concentrate more on the dust particles whereas pharmaceutical facilities are more focused on bacteria and sterilization. A cleanroom classified as ISO Class 5 or ISO Class 6 (or cleaner) requires cleanroom coveralls, along with hoods, gloves, and booties (shoe covers). For sterile processing, additional precaution is needed to assure that no sterile surfaces contact non-sterile surfaces during gowning, processing, or cleaning.
Some cleanroom standards will require your gowning process to have your employees wash and clean up within a buffer room before entering the gowning room then wear proper PPE before entering the cleanroom. These buffer rooms can also be a great place to stage equipment and other preparations that can be done outside of the cleanroom environment.
You will also want to have a space in the preparation area just before entering the cleanroom where your employees can store personal items that are not allowed in the cleanroom as well as a place to store reusable PPE.
Pass throughs are another good example of necessary items in the gown room (depending upon your protocol procedures).
Proper placement of clean garments relative to soiled/dirty garments can also be a factor in maintaining proper procedure. Planning the flow of personnel entering the gowning room, leading to the cleanroom entrance, and the path of exiting from the cleanroom and to the gowning room must also be evaluated to avoid cross contamination.
Comments