Personal Hygiene and Garbing USP 800
Sterile Hazardous Compounding <800>
Personal Hygiene and Garbing
Sterile Hazardous Compounding <800>
Purpose/ Applicability: To provide guidelines for personal hygiene and garbing for sterile compounding hazardous preparations.
Scope: Applies to all personnel who handle and perform sterile compounded hazardous preparations.
Definition(s):
ISO: International Standards Organization
DP: Designated Person
HD: Hazardous Drugs
Equipment: N/A
Procedure:
Background
- Hand hygiene, garbing procedures, and other activities that generate high particulate levels must be performed in an ISO Class 7 or higher area
- The anteroom is the transition room between the unclassified area and the buffer room and is where these procedures should take place
- Products that should be utilized for hand hygiene include antimicrobial soap, a nail pick and scrub, lint free wipes, and an alcohol-based rub or spray
- The dispensary coordinator or DP will identify potential sources of contamination within the cleanroom and distinguish necessary behaviors for cleanroom personnel
- During certification, staff will be assessed for proper hand hygiene technique
- Personnel should always be considerate of not touching anything nonsterile after completing hand hygiene processes
- Avoid touching face, adjusting mask/hair cover, or adjusting glasses/goggles
- Items not necessary for compounding must be left outside of the cleanroom (books, papers, electronic devices)
- While in the cleanroom, limit unnecessary movement
- Personnel with health conditions that could compromise the environment should not go into the cleanroom – active infections, open lesions, rashes, sunburns
Personal Hygiene Procedures
Prior to entering the cleanroom:
- Remove –
- Personal outer garments
- All cosmetics
- Garments made of high-shedding fabrics
- All hand, wrist, and other exposed jewelry or piercings that can interfere with PPE (Cover all jewelry that cannot be removed)
- Ear buds, headphones, cell phones or similar devices
- Nail polish, artificial nails, extenders (keep natural nails clean and neatly trimmed)
In anteroom:
- Perform hand hygiene appropriately
- Required before entering buffer room and is completed after donning bouffant, and mask but before donning remainder of sterile garb and gloves
- Hand hygiene procedure:
- Remove all personal outer garments, high shedding materials, cosmetics and jewelry
- Don head cover and face mask
- Turn on warm water and remove debris from underneath fingernails using a nail cleaner
- Wash hands and forearms up to the elbows with unscented antimicrobial soap and water for at least 30 seconds
- Pay special attention to the spaces between the fingers, around the thumbs, palms and back of hand
- Dry hands and forearms completely with low-lint disposal towels or wipes
- Don remainder of PPE and garb
- Reusable suit and boot and gloves
- Immediately prior to donning sterile gloves, apply an alcohol-based hand rub with sustained antimicrobial activity and allow to completely dry
- Don sterile gloves
- Follow the gowning procedures for the Hazardous Cleanroom :
- Don dedicated cleanroom shoes while entering the clean room
- Don bouffant
- Don face mask
- Wash hands and forearms at sink for at least 30 seconds, using scrub brush and nail pick
- Don cleanroom gown and boots
- Don goggles
- Use sterile alcohol to sanitize hands and allow to fully dry
- Don first pair of gloves – nonsterile chemotherapy gloves
- Disinfect gloves with sterile alcohol
- Don second pair of booties (remove prior to exiting HD room)
- Don chemotherapy gown upon entering HD room (remove prior to exiting HD room)
- Don second pair of gloves in HD room – sterile chemotherapy gloves (remove prior to exiting HD room)
- Disinfect gloves with sterile alcohol