Here's a quick quiz!
Look carefully.
Which of these poses the greatest threat to a sensitive biomanufacturing process?
Give Up?
She does!
People – even the cleanest of people
are naturally...well, naturally dirty or contaminated.
In addition to constantly shedding loads of hair and skin cells
and breathing out a plume of diverse microorganisms,
our bodies are natural hosts to undesirable bacteria, and
if we’re infected or sick- dangerous viruses and fungi as well.
Today's life science companies work tirelessly to prevent any kind of biological,
chemical or physical contamination during the manufacturing process.
Product contamination is a high-stakes issue.
If it's detected during manufacturing,
the loss of a single batch could cost millions.
If a contaminated product escaped detection and was distributed,
it could cause illness or death
and the costs of litigation and compensation may be incalculable.
One of the primary safeguards that life science companies use to help prevent contamination
in cleanroom operations is Gowning.
Gowning is basically putting on clothing
In this case layers of specially designed garments, covers, masks and gloves
that isolates your body from the clean room environment.
Gowning is more involved than just slipping on a coverall and going to work.
Gowning is itself a process,
with carefully sequenced steps to ensure that your body is fully covered,
and that the protective garb remains free of contamination.
The complexity of the gowning process is determined by the company;
but it's based on the sensitivity of the work environment.
For example, gowning for a Grade A pharmaceutical Fill Suite operation
is going to be much more rigorous than gowning for a Grade D packaging operation.
There are a few gowning concepts that are universal.
Such as being as clean as possible before even starting the process;
clean body, hair, clothes and shoes.
Removing everything that is not required in the clean room area.
This would include all personal items, jewelry, electronics...even makeup!
Avoiding contact with environmental surfaces while gowning; such as walls, lockers and
floors.
And avoiding contact with the outside of garments, gloves, masks and covers.
There are three basic gowning approaches;
top-down, bottom-up and inside-out.
This relates to the order in which garments are put on.
Top-down helps ensure that the lower garments and shoes don't pick up extra contamination...
Bottom-up helps to keep the upper garments as clean as possible...
And Inside-out covers the largest portion of your body first.
We’re going to use the top-down approach.
We'll begin by demonstrating some General Gowning
that's the basic garb for almost any processing area,
Then we'll continue on through Aseptic Gowning
that's the protection level required for most critical processing.
For General Gowning we'll be using:
Scrubs or facility suits
A Hairnet – sometimes called a bouffant -and a Beard cover
Safety Glasses
Shoe Covers
And sterile Gloves.
The process begins as you enter the locker room
or Staging Area - of the Gowning suite…
And put on your hairnet – and if needed – beard cover.
All personal items go in your locker, including any jewelry.
Then – if you’re wearing any makeup -it's time to remove it...
And wash your hands, scrubbing your arms up to the elbow.
After you select the right-size scrubs...
You can remove your street clothes down to your underwear and socks...
And put them in your locker.
After sanitizing your hands and arms with alcohol foam...
Take your scrub top and slip it on.
Followed by your scrub bottoms.
Be sure to keep the garment from touching the bench, lockers, wall…and especially
the floor!
For some operations it may be necessary to also don a lab coat at this point.
If you're just doing General Gowning for a grade D area,
it would be time to put on your dedicated footwear...
And shoe covers.
If you're gowning for Aseptic operations,
additional footwear will come later during Stage 2 gowning in the Aseptic Entry area.
After washing your hands again...
Take a pair of sterile gloves...
And open the package without touching the outer surface of the glove.
When you handle gloves with your bare hands,
always contact the inside surface.
Proper gloving technique requires practice,
but it's a skill that aseptic technicians must use several times each day.
We'll cover it in detail later.
Once the gloves are on, disinfect them with alcohol foam...
And then, after you've put on your safety glasses, you're finished.
General – or Stage 1- gowning is complete!
We're ready to move on to Aseptic Gowning.
The Aseptic Gowning Area – sometimes called the Aseptic Entry
is restricted to operators who have completed General Gowning.
Safety glasses will be replaced with a higher grade of protective eyewear at the end of
the gowning process.
Before beginning, remove all gowning overwrap and other litter,
throw it away and then clean your gloves.
The next person to gown will do the same for you.
This is good aseptic practice.
The room has a dirty – or un-gowned – side, and a clean – or gowned – side.
The sides are separated by a bench or a line,
a clear reminder of the transition from un-gowned to fully gowned.
As you enter, your gowning supplies are right by the door.
Each article is in a separate, airtight over wrap and has been irradiated to maintain sterility.
For Stage 2 gowning you'll need
Sterile gloves...
A Hood...
A Facemask...
Coveralls in your size...
Cleanroom Booties…
And goggles.
Once you've selected your garb, place it on the bench.
Lay it out rather than stacking it, so it doesn't slide off on to the floor.
After disinfecting your gloves with Isopropyl Alcohol foam or spray (IPA)
Take your hood and open the overwrap.
Handle the hood by its inside surfaces as you pull it over your head...
And then spread it across your shoulders.
Disinfect your gloved hands again with IPA…
And put on your facemask.
Tie it snugly to make sure that the mask conforms to the contours of your face.
And be sure to form the mask to the bridge of your nose…
After disinfecting your gloves again...
Open the bag containing the sterile coverall, and remove the garment.
It’s best to handle the coverall by its inside surfaces only...
And pull the garment on – one leg at a time – from a standing position.
Be very careful.
Ensure that the coverall NEVER touches the floor!
As you put your arms in the sleeves and pull the garment up over your torso,
be sure to capture the entire hood that's spread across your shoulders.
If you miss some of the hood or it bunches up,
tuck it into the coverall...
Before you zip it fully up to your neck.
Disinfect your gloves again...
And then sit on the bench to put on your footwear.
Whether you're using dedicated footwear with shoe covers
or just a provided cleanroom boot, the process is the same.
Fully extend the instep strap that goes over the top of the foot…
slide the buckle to the end…
and snap the two parts of the buckle together.
Then fold, gather or roll the top of the boot to shorten it…
Lift one foot off the floor...
And slip the boot on over your footwear.
Swing the booted leg over the bench...
And put the sterile boot down on the clean-side floor, straddling the bench.
Now repeat the process with the other boot.
Unfold the boot…
Fully extend the instep strap…
slide the buckle to the end…
Snap the buckle…
Gather the boot top…
Lift your second foot off the floor...
Slip on the boot...
Swing your leg across...
And put the sterile boot on the clean-side floor.
Now you can finish up by snapping the boot tops to your coverall…
Tightening and snapping the boot tops themselves…
And tightening the instep strap until it’s snug but comfortable.
Never put a sterile boot down on the dirty side of the bench,
and never put a dirty foot down on the clean side of the bench!
Now that you're on the clean side,
you can safely put on the rest of your required garb
goggles and a second pair of sterile gloves.
After disinfecting the gloves you’re wearing...
You're ready for your goggles.
As you place and adjust them, make sure that they:
Fit your face without leaving any gaps...
Overlap your facemask...
And overlap your hood.
There should be no skin visible around them.
Then disinfect your gloves once more
because it's time to put on some sterile outer gloves.
Proper gloving technique is critical with sterile gloves.
Your hands must only contact the inner surfaces of the gloves.
And the outer surfaces of the gloves must only contact other sterile surfaces.
Sterile gloving starts with opening the outer package on a clean work surface.
Be careful not to damage or contaminate the inner wrap.
While touching only the exterior of the inner wrap,
unfold the package and lay it out directly in front of you.
This exposes the gloves.
Each glove has a folded-up cuff.
This provides a way to grasp the glove without touching the exterior.
Grip the glove firmly by the inside surface at the fold with your right hand...
And slide your left hand inside the glove...
While you pull the glove up over your left wrist,
overlapping the cuff of the coverall.
Your left hand is now sterile,
and you can use it to handle the sterile outer surface of the second glove.
So slip the fingers of your sterile left hand into the pocket
formed by the folded-over cuff of the right glove.
Be careful to touch ONLY the exterior surface of the right glove.
Now you can slide your right hand into the glove
while only touching the interior surface.
As your left hand pulls the right glove up over your right wrist
and over the cuff of your coverall, the glove unfolds,
creating a solid overlap with the coverall.
Your sterile right hand can now slip into the fold
on the left glove and pull it the rest of the way up,
overlapping the sleeve of the coverall.
Aseptic gowning is complete,
and after a final application of alcohol to your gloved hands,
you're ready to enter the cleanroom!
And be sure to leave all your plastic overwrap
on the bench to help keep your hands sterile.
As you enter, be sure to protect your sterile gloves by opening the door with your elbow,
shoulder or hip rather than your hands.
What's so important about gowning?
Quite a bit!
In Biomanufacturing, gowning is our front-line defense against
the cloud of contamination that all of us naturally create.
It’s a fundamental skill that makes all other processes possible for our skilled workforce.
But gowning only works if the process is followed
each time and every time
precisely as it was designed, tested and validated.
In so many ways, each and every day,
proper gowning is helping to move North Carolina’s thriving life science industry forward.