Sterile Compounding and the ICC

 

• Sterile Compounding Facility

• Compounding facilities are designed to minimize airborne contamination.

  High-efficiency particulate airflow (HEPA) filter – minimizes airborne contamination.

  International Organization for Standardization (ISO) – define the amount of particulate matter allowed in room air where CSPs are prepared. The lower the ISO number, the less particulate matter is present in the air.

  
  

• Sterile Compounding Areas

• Personnel are responsible for maintaining the overall cleanliness of these areas.

  Anteroom – where personnel perform aseptic hand washing and garbing procedures, gather supplies and check expiration dates, etc.; ISO Class 8.

  Clean room – IV room or buffer area, the inner most room within the pharmacy; houses the laminar airflow hoods; ISO Class 7.Only furniture, equipment, and supplies necessary for the preparation of CSPs should be allowed in defined compounding areas; long-term storage is not permitted.

  Laminar Airflow Hoods: HEPA-filtered air to create an ISO Class 5 environment in the direct compounding area (DCA) of the hood.
  

• • Sterile Compounding Personnel

  • • Clean room access is limited to those personnel trained to prepare CSPs.
    • No cosmetics, perfume, hair spray, artificial nails, or nail polish can be worn while performing sterile compounding procedures.
    • Individuals with certain medical conditions (respiratory infections, weeping sores, rashes, and sunburn) are banned from the sterile compounding area.
    • No food or beverages in the anteroom or clean room; no horseplay and no gum.
    • Strict sequence, moving from the most dirtiest (shoe covers on shoes) to the cleanest item (donning sterile gloves).
    • Personnel must remove all outwear (coats, sweaters, hats, etc.), prior to entering the ante area.
    • Shoe Covers: placed over the technician’s closed-toed shoes to keep dirt and other substances from contaminating the floor of the clean room.

  • Garbing of Sterile Compounding Personnel

  • Hair Cover: secured to the head; avoids contamination of the hood or CSP.

    Face Mask: covers nose and mouth during compounding; catches bacteria contained in the liquid droplets and aerosols that emanate from the nose and mouth.

    

    
    
•