Personal Hygiene and Garbing
Sterile Non-Hazardous Compounding <797>

Purpose/ Applicability:  To ensure that all personnel who prepare CSPs are trained conscientiously and skillfully by expert personnel and that proper hand hygiene is fully understood to prevent contamination while in the cleanroom.

Scope: Hygiene requirements are applicable to any personnel who intend to enter the medication dispensary cleanroom.

Definition(s):

USP : United States Pharmacopeia

CSP : Compounded Sterile Product

PPE : Personal Protective Equipment

ASHP : American Society of Health-System Pharmacists

Equipment:

Required PPE

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 or 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 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

Prior to Entering Cleanroom

• All personal outer garments must be removed
• All cosmetics should be taken off
• Garments that are made of high shedding fabrics should not be worn
• All hand, wrist, and other exposed jewelry should be removed if possible
  • If it cannot be removed, it should be covered up
• No ear buds, headphones, cell phones, or similar devices are allowed into the cleanroom
• Nails cannot be polished, must be trimmed, and cannot be artificial

Once 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 boots, goggles, etc.
  • Immediately prior to donning sterile gloves, apply an alcohol-based hand rub with sustained antimicrobial activity and allow to completely dry
  • Don sterile gloves