Overview of Gowning and a Gloving Practicum
Copyright ©2009 by Gary Fromert, M.S. & Helen Scheerens, M.S.
PETRI Project, Northampton Community College
After completing this exercise, you should be able to:
1. Explain what is meant by donning and by doffing.
2. Show an understanding of the gowning procedure.
3. Show a basic proficiency in sterile gloving.
4. Explain why specialized garments are required to be worn in a cleanroom environment.
The human body is a rich source of viable and nonviable particles. It is widely considered that the
human body is the principle source of contamination in a cleanroom[1]. Flakes of skin, hair, body
microflora and aerosolized droplets from the mouth and nose are all sources of contaminants.
Reducing contamination of the cleanroom requires that anyone entering the cleanroom wear
specialized clothing while in the cleanroom. To ensure that there is consistency in minimizing
cleanroom particle contamination by human entrance into the cleanroom, gowning and gloving
procedures have been developed and must be followed.
It is the responsibility of manufacturing and QC personnel to follow these procedures and for
supervisory personnel to ensure compliance with these procedures. Though most cleanroom
facilities follow a standard set of rules for preparing to enter the cleanroom, most employers
develop a standard operating procedure (SOP) for washing, dressing, gloving and undressing
based on the design of the facility, the desired level of contamination control and the employer’s
preference. Different work areas in the same facility may have different SOPs. Employees must
follow SOPs for the facility, or area within the facility, in which they work in order to prevent
contamination and maintain compliance with regulations from the US Food and Drug
Administration (FDA) and/or the United States Pharmacopeia (USP). Proper gowning of
personnel is critical to the successful operation of a cleanroom.
Gowning
Reducing contamination through the use of specialized clothing starts with a gowning room design
that meets the same cleanliness specifications of the clean room itself. Air entering the gowning
area should be a flow of HEPA-filtered air to immediately remove personnel-emitted contaminants
and particles present in clean room garments. HEPA stands for High Efficiency Particulate Air.
HEPA filters remove large particles and decrease the overall number of particles in the air.
Gowning rooms contain two distinct areas that may be divided by either an imaginary line of
separation or a physical barrier, such as a bench, that must be crossed over to move from one area
to another. This line of demarcation separates the room into a dirty zone and a clean zone. After
crossing into the clean zone movement back into the dirty zone should be avoided.
The types of garments used vary from one cleanroom to another and procedures for donning each
type of garment will be different. However, some general guidelines for gowning pertain to most
types of clothing worn in cleanrooms. Dressing is almost always done from the head down, with
hoods or caps being put on first, then the gown or suit, then footwear. Throughout the gowning
procedure care must be taken not to touch the outside of any of the garments or let them touch the
floor or other potentially contaminated surfaces.
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A General Protocol for Gowning (See Figure 1.)
1. Remove street clothing, jewelry, watches, cosmetics etc. Put on scrubs, “blues” or other
designated clean room undergarments.
2. Put on a disposable bouffant hat or hairnet. Put on a beard cover, if required.
3. Put on disposable footwear coverings, or clean room footwear.
4. Gather the garments to be worn checking to ensure the appropriate size is selected and that the
protective packaging is intact
5. Wash hands according to the SOP for the facility. Hand washing procedures are more stringent
for facilities trying to control microbial contamination. Some facilities require employees to
put on “donning gloves” after hand washing and before putting on clean room garments.
6. Put on face mask and hood (or cap).
7. Unwrap and unfold the garment without letting it touch the floor, then put on the garment
without letting it touch the floor.
8. Fasten all garment closures and tuck in hood or yoke (if used)
9. If a crossover bench separates the changing area from the entrance area it will be used in
conjunction with donning footwear. Sit on the bench, lift one food and put on clean room
footwear. Lift same leg over to the “clean” side of the bench. Repeat the procedure with the other
foot. Stand up on the clean side. Be careful not to put your foot down on the “dirty” side at all
once you have donned the footwear.
10. Dispose of donning gloves (if used). Rewash or disinfect hands then put on powder free sterile
gloves using appropriate techniques with gloves covering the cuffs of the clean room garment.
11. The employee should check their appearance in a full length mirror to ensure that all garments
are worn correctly before entering the clean room.
12. Proceed to the entrance of the clean room.
Figure 1. Cleanroom attire.
(www.coleparmer.com/techinfo/techinfo.asp)
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Sterile Gloving
The hands can be a major source of microbial contaminants. The use of sterile gloves reduces the
chance of microbial contamination. Proper gloving technique requires that bare skin never touch
the glove’s exterior. To facilitate this, most sterile gloves come packaged with cuffs folded down
so that they can be put on without touching the outsides.
A General Protocol for Gloving (See Figure 2.)
1. Choose gloves of the appropriate size then open the outer package on a clean flat surface. Wash
your hands according to the SOP for the facility.
2. Open the inner glove wrapper, and then identify the left and right glove
3. Pick up the first glove with the dominant hand (glove picked up should be for the non-dominant
hand) by the cuff using the thumb and index finger. Touch the inside portion of the cuff only
(the side that will be touching your skin when the glove is on).
4. While holding the cuff, slip the non-dominant hand into the glove. Point the fingers of the
glove toward the floor to keep fingers open. Hold gloves above waist level and do not touch
anything else. Do not make any adjustments to the glove until the second glove is in place.
5. To pick up the second glove slide the fingers of the gloved hand under the cuff of the second
glove and slide the second hand inside. Do not touch the gloved hand with the ungloved hand
while putting on the second glove.
6. Put the second glove on the ungloved hand by pulling through the cuff. After gloves are both in
place make any necessary adjustments. Gloves should be pulled over the cuffs of the gowning
garment.
Figure 2. Gloving procedure. (www.engenderhealth.org/ip/surgical/sum4.html)
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USP Hand Hygiene and Gowning Procedures
The United States Pharmacopeia (USP) has established enforceable and detailed procedures and
requirements for Compounding Sterile Preparations (CSP). The intent is to reduce or prevent harm
to patients resulting from microbial contamination, bacterial endotoxins, and contamination of
Compounded Sterile Preparations.
The following is an excerpt from USP < 797> Pharmaceutical Compounding—Sterile
Preparations [2].
The Importance of Appropriate Hand Hygiene and Gowning
To minimize possible contamination of CSPs, it is important to ensure appropriate
personnel hand hygiene, garbing, and movement within the cleanroom/sterile compounding areas.
It is imperative that compounding personnel follow strict hygiene and aseptic
technique requirements. This is the first line of defense to prevent microbial contamination of
CSPs and the surrounding work areas and to minimize the introduction of particulate matter into
compounding areas. Because particles in the air or on work surfaces provide a vehicle for
microorganisms to be introduced into CSPs, it is necessary to cover as many exposed surfaces as
possible on compounding employees. With normal movements, the human body sheds squamous
cells at a rate of at least 106 per hour and each particle has the potential to transport
microorganisms. Proper garbing and hand hygiene do not totally eliminate all particles, but they
can decrease the particulate burden in the controlled environment.
Garbing Procedure
The following steps constitute a recommended and USP <797> compliant garbing procedure:
Remove outer garments (including coats or jackets, hats, scarves, and sweaters), cosmetics, and
visible jewelry, prior to entry into the cleanroom or compounding area. Scrubs are not required,
but donning clean scrubs will likely increase employee comfort during the compounding process,
since scrubs are generally cooler and lighter than street clothes. An additional best practice
suggestion is to change into the scrubs after entering the work facility to reduce the chance of
introducing bacterial and fungal contamination.
Artificial nails or extenders are prohibited and should not be worn. Natural nails must be kept neat
and trimmed.
Garbing order should be dirtiest to cleanest (as detailed below) and based on current facility layout
for storage of supplies and entries into anteroom and cleanroom areas.
Donning (Gowning) Sequence
1. Don dedicated shoes or shoe covers. If dedicated shoes are used, they should be resistant to
disinfectants and stored in the anteroom or changing area. They should be cleaned on a regular
basis and should not be worn outside the cleanroom/anteroom area. Shoe covers are should be
worn once and removed after exiting the cleanroom.
2. Don head cover and facial hair cover, if applicable.
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3. Don face mask and eye shield. An eye shield is optional, except during cleanroom disinfection
activities and preparation of hazardous drugs.
4. Cleanse hands as follows:
Hand Hygiene Procedure
After donning head cover, shoe covers, and face mask, careful and thorough hand cleansing is
next. The first steps of hand hygiene should be performed in the anteroom and prior to donning the
non-shedding gown. Because tap water can be a source of microbial contamination, the gown
should be donned after hand washing, thus minimizing the chance of water-borne bacteria
splashing on the gown.
A. Remove debris from underneath fingernails with a nail cleaner and warm water.
B. Wash hands and forearms to the elbow for at least 30 seconds with non-antimicrobial or
antimicrobial soap and water. Hand washing should be vigorous and thorough.
C. Do not use antimicrobial scrub brushes on the skin, as they can damage the skin and increase
skin shedding.
D. Completely dry the hands and forearms using lint-free disposable wipes or an electronic hand
dryer.
E. Continue with garbing process.
5. Don non-shedding gown with sleeves that fit snugly around the wrists and an enclosure at the
neck. Compounding personnel generally prefer gowns that snap or button in the front, for ease of
use, but USP Chapter <797> does not specify a required gown type. It is preferable to use a
disposable gown, which may be stored in the anteroom and reused for one shift, if not visibly
soiled or ripped. If reusable gowns are worn, they should be laundered appropriately for
cleanroom use.
6. Enter the cleanroom or segregated compounding area. Use a waterless alcohol-based surgical
hand scrub to further cleansing. Initial gloving is completed by spraying the gloves with sterile
70% IPA. Allow hands to dry prior to donning sterile gloves.
7. Don sterile, powder-free gloves.
8. Sterile gloves should be disinfected by wiping or rubbing sterile 70% isopropyl alcohol (IPA)
on all surfaces of the gloves after they make contact with non-sterile surfaces, as well as routinely
throughout the compounding process. The IPA should be allowed to fully dry before
compounding duties are resumed. Continue to inspect gloves for holes or tears throughout the
compounding process.
After donning cleanroom garments personnel may walk through air showers or other pressurized,
interlocked air locks to protect the integrity of the cleanroom from cross-contamination of lesser
cleanroom areas.
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Doffing (Gowning Removal)
After compounding is complete and personnel exit the cleanroom/compounding area, all garb
items, except the gown, must be disposed of.
Reverse the above procedure. Place disposable items in trash. Place reusable coverall, hood, and
boots in proper receptacle. Place goggles in separate receptacle. Exit gowning area. In cases of
emergency evacuation, personnel are instructed to immediately leave the cleanroom without
doffing cleanroom garments.
Re-entry
For re-entry into the cleanroom/compounding area, don new garb (except the gown as previously
mentioned) and perform hand hygiene.
Gowning Demonstration and Gloving Practicum
In this laboratory exercise you will be given a demonstration of gowning or performing a gowning
practicum and performing a sterile gloving practicum.
Materials (per class)
At least one set of cleanroom garments
A long bench
Full length mirror
Packages of sterile gloves (assorted sizes)
Procedure for Gowning Demonstration
Your instructor or a student will demonstrate the proper technique for donning cleanroom
garments. In addition to the demonstration, your instructor may require that each student perform a
donning/doffing procedure.
Procedure for Gloving Practicum
Each student should practice donning sterile gloves following the General Protocol for Gloving
above and using Figure 2 as a guide. Lab partners can critiques each other’s gloving technique.
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Laboratory Review
1. Explain what is meant by donning of cleanroom garments:
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
2. Explain what is meant by doffing of cleanroom garments:
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
3. Speculate as to why there is a specific order for donning and doffing cleanroom garments:
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
4. Why are specialized garments required to be worn in the cleanroom environment:
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
5. Why is it important to have a line of demarcation in the gowning area?
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
6. When gloving, why is it important to pull the sterile gloves over the cuffs of the sleeves of the
cleanroom gown or suit?
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
7. Why should both gloves be fully donned before making any adjustments to the fit?
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
_______________________________________________________________________________
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Gowning Glossary
Anteroom - An anteroom is an ISO Class 8 or better area where personnel
perform hand hygiene and garbing procedures, staging of components, order entry, CSP labeling,
and other high-particulate generating activities. It is also a transition area that 1) provides
assurance that pressure relationships are constantly maintained so that air flows from clean to
dirty areas and 2) that reduces the need for the heating, ventilating and air conditioning (HVAC)
control system to respond to large disturbances.
Doffing - To take off cleanroom garments in designated "degowning areas" in anterooms to the
cleanrooms.
Donning - To put on cleanroom garments in designated "gowning areas" in anterooms to the
cleanrooms.
References
[1] Carlberg, David M., Cleanroom Microbiology for the Non-Microbiologist, 2nd Ed., CRC
Press, Boca Raton, FL, 2005
[2] U.S. Pharmacopeia 27NF22, Chapter < 797> Pharmaceutical Compounding—Sterile
Preparations. Rockville, MD 2008
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