USP 797 – Garbing and Donning

It is the responsibility of each facility to define and prioritize gowning order SOPs in a way that best reduces contamination risks.

USP 797 2019 – Garment Requirements – (Revision Bulletin) (Pg. 7)

Any person entering a compounding area must be properly garbed in accordance with the facility’s SOPs. Garb must be donned and doffed in an order that reduces the risk of contamination.

The order of garbing must be determined by the facility and documented in the facility’s SOP.

Sterile gloves must be donned in a classified room or SCA.

Skin must not be exposed inside the ISO Class 5 PEC (e.g., gloves must not be donned or doffed inside the ISO Class 5 PEC exposing bare hands).

Donning and doffing garb should not occur in the ante-room or the SCA at the same time. The minimum garbing requirements include:

• Low-lint garment with sleeves that fit snugly around the wrists and that is enclosed at the neck (e.g., gowns or coveralls)

• Low-lint, disposable covers for shoes

• Low-lint, disposable covers for head that cover the hair and ears, and if applicable, disposable cover for facial hair

• Face mask

• Sterile powder-free gloves

• If using a RABS, such as a CAI or CACI, disposable gloves (e.g., cotton, nonsterile, sterile) should be worn inside gloves attached to the RABS sleeves. Sterile gloves must be worn over gloves attached to the RABS sleeve.

Garb must be replaced immediately if it becomes visibly soiled or if its integrity is compromised.

Gowns and other garb must be stored in a manner that minimizes contamination (e.g., away from sinks to avoid splashing). When personnel exit the compounding area, garb except for gowns cannot be reused and must be discarded.

Gowns may be re-used within the same shift if the gown is maintained in a classified area or inside the perimeter of an SCA.USP 797 2008 (Revision Bulletin) (Pg. 29

Order of Compounding Garb and Cleansing: (Outdated)

Personnel shall don the following PPE in an order that proceeds from those activities considered the dirtiest to those considered the cleanest. Garbing activities considered the dirtiest include donning of dedicated shoes or shoe covers, head and facial hair covers (e.g., beard covers in addition to face masks), and face masks/eye shields. Eye shields are optional unless working with irritants such as germicidal disinfecting agents or when preparing hazardous drugs.

Personnel shall don the following PPE in an order that proceeds from those activities considered the dirtiest to those considered the cleanest. Garbing activities considered the dirtiest include donning of dedicated shoes or shoe covers, head and facial hair covers (e.g., beard covers in addition to face masks), and face masks/eye shields. Eye shields are optional unless working with irritants such as germicidal disinfecting agents or when preparing hazardous drugs.

After donning dedicated shoes or shoe covers, head and facial hair covers, and face masks, a hand cleansing procedure shall be performed by removing debris from underneath fingernails using a nail cleaner under running warm water followed by vigorous hand washing. Hands and forearms shall be washed to the elbows for at least 30 seconds with soap (either nonantimicrobial or antimicrobial) and water while in the ante-area. The use of antimicrobial scrub brushes is not recommended because they can cause skin irritation and skin damage. Hands and forearms to the elbows will be completely dried using either lint-free disposable towels or an electronic hand dryer.

After completion of hand washing, a nonshedding gown with sleeves that fit snugly around the wrists and enclosed at the neck is donned. Gowns designated for buffer area use shall be worn, and preferably they should be disposable. If reusable gowns are worn, they should be laundered appropriately for buffer area use.

• Dedicated cleanroom shoes or shoe covers

• Head and facial hair covers

• Face mask

• Fingernail cleansing

• Hand and forearm washing and drying

• Donn non-shedding gown

• Use water less alcohol-based surgical scrub

• Allow hands to fully dry

• Don sterile, powder-free gloves

• Disinfect gloves with sterile IPA, allow to fully dry

• Inspect for holes immediately and throughout

Personal Hygiene and Gowning Procedures

〈797〉 Pharmaceutical Compounding—Sterile Preparations Revision Bulletin 2008

<797> Pharmaceutical Compounding—Sterile Preparations 2019

Subject to Change

USP specifications are subject to change, as are organizational SOPs, and state by state requirements. For help regarding localized requirements, most locations benefit from contacting their State Board of Pharmacy. The content herein does not constitute a recommendation for your facility. 

The proper cleanroom gowning room design, gowning supplies and equipment are essential for cleanroom contamination control. This informational guide should never take precedence over consulting with a cleanroom contamination specialist who is familiar with your specific equipment and classification needs. For help with cleanroom construction, gowning selection, or furniture purchases, our controlled environment specialists are available for a zero-cost consultation by phone or email.