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 :

 

  1. Don dedicated cleanroom shoes while entering the clean room
  2. Don bouffant
  3. Don face mask
  4. Wash hands and forearms at sink for at least 30 seconds, using scrub brush and nail pick
  5. Don cleanroom gown and boots
  6. Don goggles
  7. Use sterile alcohol to sanitize hands and allow to fully dry
  8. Don first pair of gloves – nonsterile chemotherapy gloves
  9. Disinfect gloves with sterile alcohol
  1. Don second pair of booties (remove prior to exiting HD room)
  2. Don chemotherapy gown upon entering HD room (remove prior to exiting HD room)
  3. Don second pair of gloves in HD room – sterile chemotherapy gloves (remove prior to exiting HD room)
  4. Disinfect gloves with sterile alcohol

 



Keywords:
PPE, Garb 
Doc ID:
130914
Owned by:
Jenny C. in UofI College of Veterinary Medicine Teaching Hospital
Created:
2023-09-06
Updated:
2023-09-07
Sites:
University of Illinois College of Veterinary Medicine Teaching Hospital