Definition and Purpose of the Anteroom:
Under the USP 800, an anteroom is defined as “An ISO Class 7 or cleaner room” where personnel hand hygiene, garbing procedures, and other activities that generate high particulate levels are performed. The ante-room is the transition room between the unclassified area of the facility and the buffer room. USP 800 requires ante-rooms to produce inward air migration of same cleanliness classified air into the negative buffer room to contain any airborne Hazardous Drug (HD). Another requirement of the USP 800 for ante-rooms is that a hand-washing sink must be present at least one meter from the entrance to the HD buffer room to avoid contamination into the negative pressure HD buffer room.
Airflow and Containment:
Aanterooms must facilitate inward air migration of the same cleanliness-classified air into the negative pressure buffer room. This inward airflow is essential to contain any airborne hazardous drugs (HDs) and prevent their escape into less controlled areas. By maintaining a negative pressure gradient, the anteroom helps ensure that any contaminants are confined within the buffer room, thereby protecting both personnel and the environment.
Hand-Washing Sink Placement
Sink must be located at least one meter (approximately 3.3 feet) from the entrance to the HD buffer room. This requirement is designed to minimize the risk of contamination entering the negative pressure HD buffer room. Proper placement of the sink ensures that personnel can perform hand hygiene without compromising the controlled environment of the buffer room.
How many anteroom designs AE have?
Aseptic Enclosures offers a wide variety of designs in order to meet your needs and satisfaction in regards to the layout of your project. An example of the versatility of our MCC is the ability to create clean zones by prohibiting the ante-room from dumping air into the negative pressure buffer room. This process keeps the buffer room cleaner by design.
Aseptic Enclosures also offer a more traditional build per USP 800 which focuses on other aspects such as the work area, Positively pressurized ante-room, gowning zones, handwashing sink, and a positive buffer room. This traditional anteroom build is positive pressure so the air goes straight to the HD buffer room when the door is open.
This is only a small portion of the features that makes our Mobile Compounding Cleanroom compliant with the USP 800 guidelines for Hazardous Drug Compounding.
Read more about our Mobile Compounding Cleanrooms.
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