Cleanrooms are designed and constructed to prevent contamination from airborne particles. The elimination or ability to minimize these harmful particles from getting into your cleanroom is imperative to your manufacturing processes and ultimately to the safety of your products.

But a cleanroom alone isn’t enough. What you wear — and how you wear it when entering and working in the cleanroom is equally as important to safeguard against contaminants. This article outlines why cleanroom gowning is necessary and the steps to take for proper cleanroom gowning. We’ve also highlighted some of the helpful features you’ll find in Vestis™ products that are designed to make it easier to adhere to cleanroom gowning procedures.

Why Cleanroom Gowning is So Important

While cleanrooms must control contamination, there are different classifications of cleanrooms. The International Standards Organization (ISO) defines the level of clean based on the number of particles per cubic foot of air allowed in the cleanroom. ISO 5 cleanroom requirements list 3,500 particles of 0.5 microns per cubic meter.

Maintaining ISO 5 cleanroom conditions are required in the fields of biotechnology, pharmaceutical, and various cleantech manufacturing applications. The biggest source for potential contamination in your ISO 5 cleanroom comes from the people who work in those controlled spaces. If your product is produced under aseptic conditions, sterile gowning and appropriate gowning procedures are paramount to the cleanliness and success of your cleanroom.

As soon as a person enters a sterile cleanroom, the chances of contamination increases. Humans host up to 5 billion microorganisms per square centimeter on their skin. Every time a person goes into a cleanroom, their skin cells and those microorganisms are shedding. The potential for microorganisms getting into the sterile environment poses a very real threat to the production of the end product. Aseptic gowning practices help minimize the chance of microbial contamination migrating from the person into the product in the cleanroom.

Cleanroom Gowning Requirements

Before an employee steps into a gownroom and starts cleanroom gowning, they must take precautions to help maintain cleanroom requirements.

Best practices to be performed prior to starting the cleanroom gowning process include:

• Showering
• Washing hair
• Removing makeup and nail polish
• Donning clean clothing
• Wearing socks that cover ankles
• Washing hands

Prior to entering the locker room, outer clothing should be removed and replaced with cleanroom-processed scrubs. Scrub tops must be tucked into scrub pants. Eyeglasses are to be cleaned. Skin and hair must be covered with a bouffant cap and beard cover to prevent hair/microorganisms from shedding inside the cleanroom. If dedicated plant shoes are worn, street shoes are removed in the locker room and replaced with the dedicated shoes. Shoe covers are worn over the shoes while transferring from the locker room to the gown room.

Cleanroom Gowning Procedures

What you wear in the cleanroom impacts cleanliness in the cleanroom. You should look for garments that have added features that make aseptic gowning easier. We’ll cover some of those features later.

Common types of cleanroom garments include:

• Disposable cap for head and hair
• Beard cover when necessary
• Apparel to cover the body such as a gown, frock, smock or coverall
• Mask
• Hood
• Gloves
• Shoe or boot covers

It’s not enough to simply don cleanroom apparel. There are strict cleanroom gowning procedures that must be followed. Cleanroom gowning should be practiced multiple times until a level of confidence or certification is achieved. The wrong time to start practicing is when you have to go into the cleanroom.

Aseptic gowning begins in the pre-gown room. Prior to entering, employees should wash their hands. Once inside the gown room, a second hairnet/beard cover needs to be placed over the existing ones. Sit on the bench and place new shoe covers over the locker room shoe covers.

Gloves

Employees may walk to the clean side of the room after washing hands one more time. Two pairs of sterile gloves should be selected. The outer wrap of the glove package should be removed and the wallet placed on a dedicated shelf. The outer wrap can be discarded. The wallet should be carefully opened without touching the outer surface of the gloves.

To put the gloves on, grasp one glove at the top where it is folded. Only the inner portion of the glove should be touched. Insert the hand and pull the glove on. Using the gloved hand, several fingers can be inserted under the folded cuff of the second glove. Insert the ungloved hand into the glove without allowing the outer part of the glove to contact skin. Unfold the glove cuffs and pull over the scrub sleeves. Repeat the process with a second pair of gloves.

Be sure to sanitize the entire bench surface, wiping in one direction only with overlapping strokes. Sanitize gloves before moving to the next step.

Select items to gown and check for the proper size. Vestis makes this easier with color-coded bias tape with visual cues that identify the size and type of garment you need without touching multiple packages.

Hoods and Masks

Select a hood and mask. Be sure to check the expiration date and package integrity and then sanitize the bag before placing it on the shelf. Remove the hood from the package and handling it only by the inside, place it over your head ensuring that the hairnet is completely covered and hood is centered around your face. Vestis hoods are designed with a tunneled elastic back with vertical and horizontal snaps for a snug fit and a larger opening in the back to make it easier to slip over the head. Gloves should be sanitized again. Do not speak during this process.

Remove the face mask from the package, hold it by the top and cover the nose and mouth. Pinch the nose bridge for a secure fit. Secure the ties without allowing them to contact the scrubs. Once again, sanitize your gloves.

Coveralls

Use a mirror to help you successfully perform cleanroom gowning. Open the coverall package and remove it by holding the label and allowing the garment to hang freely. Inspect for any damage. While there are a few ways to don a coverall, you should never allow the legs or sleeves to touch the floor or allow your gloved hand to contact your scrubs. Use care when containing the hood into the coverall. The front lapels should not touch your scrubs. To minimize contamination, handle only the zipper. Be sure all closures at the neck and ankles are secure. Check in the mirror to ensure that the garment is properly sealed and there is no visible damage to the garments. Again, sanitize your gloves.

While there are many coveralls that help maintain cleanliness in your cleanroom, there are inherent features built into some that make cleanroom gowning easier and decrease chances of contamination.

Vestis uses tunneled elastic cuffs, which provide a better barrier when compared to standard knit cuffs. This makes it easier to insert gloved hands. Thumb loops on Vestis coveralls reduce the need for adjustments and help secure sleeves from riding up the arm during routine activities. Also look for full-length front coil zippers which provide a wider opening for easier access to the entire body. This helps eliminate the awkward reaching and bunching you get from coveralls with a back zipper.

Boots

Open the boot package and remove the boot. Place the packaging behind you and sit on the bench. Handle from the inside and place one foot into the boot. Cross over the bench being careful to not allow the straps to touch the floor. Buckle the strap and remove the second boot and repeat the steps. Pull both boots to the knees and seal the closures. Sanitize your gloves.

Vestis uses tunneled elastic rather than standard elastic to help prevent elastic particles from shedding into the cleanroom, as well as an elastic top which helps ensure a complete closure around the calf. We also include a socket snap adjustment that’s easier to close than traditional laces or buckles.

Goggles

Remove the goggles from the bag and adjust the strap. Place the front onto your face, sealing the mask and hood for a total seal. Position the strap over the hood and secure. It’s important to note that a strap is more secure than elastic. The former may stretch or slip during donning. Sanitize your gloves.

Final Gloves

Select the proper glove size. Remove the outer wrap of the glove package and place the wallet on the shelf. Discard the outer wrap. Remove the outer pair of gloves and discard them. Place the loops on the thumbs and carefully open the wallet while being careful not to touch the outer gloves. Grasp one glove at the top where it is folded. Be sure to touch only the inner portion of the glove. Insert your gloved hand and pull on. Using the gloved hand, insert several fingers under the folded cuff of the second glove. Insert the single gloved hand into the glove. Unfold the gloved cuffs and pull over the coverall sleeves.

To end the cleanroom gowning procedure, take one final look in the mirror to ensure proper cleanroom gowning fit and configuration. You can now enter the cleanroom with your arms in an aseptic position.

Custom Folding for Efficient Aseptic Gowning

There’s no doubt that cleanroom gowning procedures can be a tedious, albeit necessary, process. But there are ways to make it more efficient and easier for the wearer.

Vestis can customize folding of pre-packaged cleanroom gowning. With standard folding, wearers have to be careful not to allow the gown to touch the floor. This often means they are taking time to roll up pant legs or make adjustments on their own. Vestis eliminates that step and helps prevent accidental floor contact by folding garments in our cleanroom to enhance gowning and sterilizing in customers’ cleanrooms. We’ll also package hoods and masks together to make them easier to put on and create less packaging.

For more information on how Vestis can help you address your cleanroom gowning needs, contact us today. Our industry experts can walk you through our cleanroom gowning and supplies.