Copyright ©2009 by Gary Fromert, M.S.
PETRI Project, Northampton Community College
After completing this exercise, you should be able to:
1. Explain what is meant by donning.
2. Explain what is meant by doffing.
3. Show an understanding of the gowning procedure.
4. Show a basic proficiency for gloving.
5. 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 consistancy 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.
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. 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 from the dirty zone into the clean zone movement back to the dirty zone should be avoided.
The types of garments 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
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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.
1. Remove street clothing, jewelry, watches, cosmetics etc. Put on 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 packaging is intact
5. Wash hands according to the SOP for the facility. Hand washing procedures are more stringent for facilities trying to control contamination by microbial agents. 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 clean room.
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Figure 1. Cleanroom attire. (www.coleparmer.com/techinfo/techinfo.asp)
The hands are a major source for microbial contaminants. The use of sterile gloves reduces the chance of microbial contamination. Proper gloving technique requires that the glove’s exterior not be touched by bare skin. Most sterile gloves come packaged with cuffs folded down so that they can be put on without touching the outsides.
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
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3. Pick up the first glove with the dominant hand (glove picked up should be for the nondominant 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 your non-dominant hand into the glove. Point the fingers of the glove toward the floor to keep the fingers open. Do not to touch anything and hold the gloves above your waist level. 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. 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 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)
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.
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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.
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:
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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 and gloving is complete (and prior to spraying gloves with sterile
70% IPA), the hands. 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.
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 group)
A set of cleanroom garments
A long bench
Full length mirror
Procedure
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 the donning/doffing procedure.
Materials (per student)
Package of sterile gloves
Procedure
Practice donning sterile gloves following the General Protocol for Gloving above and Figure 2.
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Laboratory Review
1. Explain what is meant by donning of cleanroom garments:
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2. Explain what is meant by doffing of cleanroom garments:
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3. Speculate as to why there is a specific order for donning and doffing cleanroom garments:
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4. Why are specialized garments required to be worn in the cleanroom environment:
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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.
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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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