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Pharmacy CSP Preparation: Personnel Garbing and Gloving

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Pharmacy CSP Preparation: Personnel Garbing and Gloving

  1. 1. Personnel Garbing and Gloving for the Cleanroom
  2. 2. Of the many potential sources of contamination in cleanrooms and other clean manufacturing environments, none is more persistent, pervasive or pernicious than the human beings who occupy them. ~Jan Eudy “
  3. 3. Definitions: Term Definition Compounded Sterile Preparation (CSP) a sterile drug product that has been prepared by compounding by a qualified individual in a sterile environment. CSPs are not explicitly defined in USP <797>. However, USP <797> does state that certain dosage forms must be sterile when administered to patients. Ante-Area An ISO Class 8 or better area where personnel hand hygiene and garbing procedures, staging of components, order entry, CSP labeling, and other high-particulate-generating activities are performed. 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) reduces the need for the heating, ventilating, and air-conditioning (HVAC) control system to respond to large disturbances. Buffer Area An area where the primary engineering control (PEC) is physically located. Activities that occur in this area include the preparation and staging of components and supplies used when compounding CSPs. Cleanroom A room in which the concentration of airborne particles is controlled to meet a specified airborne particulate cleanliness class. Microorganisms in the environment are monitored so that a microbial level for air, surface, and personnel gear are not exceeded for a specified cleanliness class. Personal Protective Equipment (PPE) Equipment worn to minimize exposure to a variety of hazards. Examples of PPE include such items as gloves, foot and eye protection, protective hearing devices (earplugs, muffs) hard hats, respirators and full body suits.
  4. 4. Particles shed from compounding personnel pose an increased risk of microbial contamination of critical sites of CSPs.
  5. 5. Squamous cells are normally shed from the human body at a rate of 106 or more per hour, and those skin particles are laden with microorganisms.
  6. 6. Individuals with rashes, sunburn, weeping sores, conjunctivitis, active respiratory infection shed particles at even higher rates. Compounding personnel with these conditions shall be excluded from working in ISO Class 5 and ISO Class 7 compounding areas until their conditions are remedied.
  7. 7. Before entering the buffer area or segregated compounding area, compounding personnel shall remove personal outer garments*; all cosmetics; and all hand, wrist, and other visible jewelry or piercings+ that can interfere with the effectiveness of PPE (e.g., fit of gloves and cuffs of sleeves) *bandannas, coats, hats, jackets, scarves, sweaters, vests +earrings, lip or eyebrow piercings
  8. 8. The wearing of artificial nails or extenders is prohibited while working in the sterile compounding environment. Natural nails shall be kept neat and trimmed.
  9. 9. Garbing and Hand Hygiene in the Ante-area
  10. 10. Personnel shall don PPE in an order considered dirtiest to cleanest: head and facial hair covers (i.e. beard covers) face masks/eye shields* dedicated shoes or shoe covers * Eye shields are option unless working with irritants such as germicidal disinfecting agents or when preparing hazardous drugs 1 32 4
  11. 11. After donning dedicated shoes or shoe covers, head and facial hair covers, and face masks, perform hand hygiene. 2 31 4
  12. 12. Remove 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.* Hands and forearms to the elbows will be completely dried using either lint-free disposable towels or an electronic hand dryer.+ * The use of antimicrobial scrub brushes is not recommended because they can cause skin irritation and skin damage. + The use of hand dryers in the cleanroom is a topic of discussion as studies have shown that hand dryers may spread bacteria from hands into the air 2 31 4Hand hygiene:
  13. 13. 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. 321 4
  14. 14. You may now enter the buffer area or segregated compounding area
  15. 15. Once inside the buffer area or segregated compounding area, and prior to donning sterile powder-free gloves, antiseptic hand cleansing must be performed using a waterless alcohol-based surgical hand scrub with persistent activity following manufacturers‘ recommendations. 1 2
  16. 16. Allow hands to dry thoroughly following application of alcohol-based surgical hand scrub, then… Don sterile powder-free gloves. 21
  17. 17. You are now ready to begin sterile compounding using strict aseptic technique
  18. 18. Routinely disinfect gloves with sterile 70% Isopropyl alcohol (IPA) throughout the compounding process and after contacting nonsterile objects Only use gloves that have been tested for compatibility with alcohol disinfection by the manufacturer Inspect gloves for holes and replace when breaches are detected
  19. 19. Compounding personnel exiting compounding area during a work shift may remove and retain exterior gown in compounding area, if not visibly soiled, to be re-donned during the same work shift. Shoe covers, hair and facial hair covers, face masks/eye shields, and gloves must be replaced with new ones before re-entering compounding area. Compounding personnel exposed to air quality known or suspected to be worse than ISO Class 7 must re-garb PPE along with perform hand hygiene, including antiseptic hand cleansing with waterless alcohol- based surgical hand scrub, and don sterile gloves upon reentering buffer area.
  20. 20. When CAIs and CACIs are the source of the ISO Class 5 environment, the garbing and gloving requirements for compounding personnel should be as described, unless the isolator manufacturer can provide written documentation based on validated environmental testing that any component(s) of PPE or personnel cleansing are not required.
  21. 21. JERRY FAHRNI, PHARM.D.

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