In cleanroom settings, it is necessary to follow the proper protocols to maintain the integrity of the cleanroom and prevent contaminants from entering the controlled environment. Proper cleanroom gowning protocol is one of the most critical guidelines to follow, since contamination via personnel is among the primary risks in the cleanroom.
Following the correct cleanroom gowning steps and procedures can make the difference between safe cleanroom processes that meet the necessary standards and requirements, and contamination that can compromise testing, research and results. Contaminated cleanrooms almost always lead to lost time and effort and require cleaning, downtime and rework.
Cleanroom Gowning Requirements
To meet the needs of the cleanroom, proper gowning processes and requirements must be met. This involves the correct materials, donning and doffing procedures, and processes within the cleanroom. Here, we will look at the principles of each of these areas.
Cleanroom Equipment — What Do You Need?
Having the necessary cleanroom equipment on hand is the first step toward successful cleanroom procedures.
The basics of proper cleanroom attire may include:
- Bouffant cap for head and hair
- Beard cover
- Gown, frock, smock, or coverall
- Sterile gloves
- Shoe covers
- Second sterile gloves
- Second shoe covers
In addition, paper towels, soap, disinfectants, hand sanitizer and sterile alcohol should be available.
With the proper gowning equipment on hand, you are ready to follow the correct donning procedures.
- Use the mat: As you enter the gowning area, be sure to step on the tacky mat just outside the entry door with both feet to remove gross contamination from both shoes.
- Work from top to bottom: Because contaminants can loosen and fall as cleanroom gowning equipment is donned, you should work from the top of your body to the bottom so that sterile garments are not contaminated. It would also be counterproductive to touch your dirty shoes right before touching your hair and face.
- Proper fit: All gowning equipment should be properly sized, and personnel should not “make do” with an improperly sized piece of equipment, which can result in a loose fit and increased risk of contamination. PPE that is too small tears open, PPE that is too large wrinkles for friction points and acts as a bellows as you move, spreading your contamination through any possible opening.
- Full coverage of “outside” clothing: No outside clothing should be visible or accessible through gowning equipment.
- Do not contact clean garments with bare hands: Gloves should always be used, and should be sanitized between every step of donning cleanroom equipment.
- Double when necessary: For example, two pairs of sterile gloves are required for aseptic procedures.
- Do a visual check: Always check your gowning equipment in the mirror before entering the cleanroom, so you can be further assured that you have donned all necessary equipment with a proper fit.
Cleanroom Best Practices
As you prepare to enter the cleanroom and carry out work within it, it is important to adhere to the following best practices (and more):
- Cleanroom safety starts before arriving at the facility: Cleanroom personnel should be showered and well-kempt to minimize the risk of outside contaminants being transferred into the cleanroom. In addition, make-up, colognes, perfumes, aftershaves, and other aerosols or atomized materials should not be used, since these can be difficult to contain.
- Clean frequently: Gloves and other equipment should be sanitized regularly while working in the cleanroom so that potential contaminants are minimized and eliminated.
- Move slowly: Fast movements carry a much higher risk of disturbing particles that can compromise the cleanroom. Slow, deliberate movements not only reduce the risk of accidents, they help to prevent contaminants from moving through the air.
- No external materials: Jewelry, keys, cellphones, and other devices and materials should remain outside the cleanroom in a secure area. These are not necessary for cleanroom processes and carry an immense risk of compromising materials and equipment. If a cellphone is needed in a cleanroom, it must be placed inside a bag and the bag must be cleaned.