In a cleanroom environment, microbial control is of utmost importance. Presence of contaminants can result in product recalls and even the death of a consumer. The primary source of contamination in a cleanroom is the people.
To protect the products from contamination, personnel should use aseptic gowning techniques and the proper gowning supplies. By doing so, it helps to reduce contamination and maintain compliance with various standards such as usp 797 and usp 800.
Aseptic Gowning Supplies
Protective apparel for aseptic environments can be purchased as sterile for one time use or reusable. If garments are reusable the washing process must be validated.
The following supplies must be sterile and non-shedding:
- Face mask
- Hood
- Protective goggles
- Gloves
- Coveralls
- Boot covers
Aseptic / Sterile Gowning Procedure
Its important to follow a specific sequence when gowning for a sterile environment. Application of protective apparel should start from the top down starting with covering the head. Good hygiene including properly washed hands, hair, body and the removal of jewelry and makeup are also critical to maintaining a clean environment.
Pre-entry
- Bouffant/ Hair net. Contain all hair within the hair net.
- Shoe covers. Contain laces within the shoe covers.
Gowning
- Sterile gloves. Put on sterile gloves after thoroughly washing hands with antibacterial soap. Dry hands after washing. Put on gloves by only touching the inside of the glove. Sanitize each glove after donning (if required).
- Face mask. Cover the nose and mouth and adjust the mask to a snug fit. Wear a bear cover if needed.
- Hood. Make sure the elastic closure fits snug around the face.
- Coverall. Carefully unpack the cover and make sure it does not touch the floor or other surrounding furniture. Step into the cover starting with both feet and then arms.
- Boot covers. Place boot covers over coveralls. This should be done in the clean area of the gowning room.
- Goggles
- Second set of sterile gloves. Place the second set of sterile gloves making sure they fit securely over the sleeves of the coverall.
Aseptic / Sterile Garment Removal Procedure
Garment should be removed in the reversed order that they were donned.
Outer set of gloves > Goggles > Boot covers > Coverall > Hood > Face Mask > Gloves >Shoe Covers > Hair Net
Establishing an Aseptic Gowning Qualification Program
Employee Training
To ensure your employees understand proper aseptic gowning techniques, carry out user training. The best way to achieve this is through video technology. The use of video demonstrates to your personnel the correct aseptic gowning techniques.
Videos also enable the trainer to note any flaws in the techniques. If these flaws go unnoticed, it can result in contamination. Identifying the flaws early helps the trainer to make changes to the techniques.
There are companies which have taken training a notch higher and built an Aseptic Training Suite.
Observation and Practice
In this stage, the trainer observes the personnel as they gown in a safe and noncritical area. The first thing the personnel ought to do is observe good hygiene. They should also remove any makeup, jewelry, and don shoe covers, place a hairnet and gown for Grade C areas.
If the employee demonstrates experience and knowledge in gowning for Grade C areas, you can proceed with the practice for Grade B areas. For this area, the employee will have to put on an extra hairnet.
It is important to inspect the gowning components while in their packaging. The employee has to check the expiry date and the integrity of the packaging. When it comes to the coveralls, they should not touch the floor and after gowning, sanitize the gloves.
In cleanroom gowning, the personnel has to tighten and snap all closures.
Using Contact Plates
In stage three, contact plates help to determine if the personnel gowned according to the cleanroom standards. The trainer checks the contact plates to ensure the trainee gowned without contaminating:
-
- Sterile gloves
- Sterile head cover
- Sterile outer gown
The trainer has to ensure that the trainee undergoes three gowning processes. These processes have to be successive. Afterward, the employee has to undergo microbiological sampling. The sites to sample include:
- Shoulders
- Hoods
- Boots
- Thighs
- Chest
- Forearms
- Gloved fingers
- Facemask
It is important to ensure that any employee does not proceed to Grade A areas if they have not participated in a media fill. The trainer must also carry out program maintenance, re-qualification, routine monitoring, and disqualifications.
In re qualification, personnel must take part in refresher courses, and annual media fill.
More Aseptic Gowning Guidelines
In aseptic gowning, trainers and personnel must protect the cleanroom equipment and the integrity of the cleanroom supplies. This is typically accomplished through retraining. Remember, proper gowning helps to prevent contamination by personnel.
As such, it’s essential to practice proper cleanroom behavior and gowning practices.
Additional Information
Cleanroom Apparel Product Category
Cleanroom Clothing Requirements and Selection Guide
Non-Sterile Cleanroom Gowning Procedure
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