Ante room or iso class 8 environment

The ante room, or ISO Class 8 environment, is the outermost ring of the three areas. USP 797 defines this environment as the area where handwashing, garbing, gathering of components needed, order entry, labeling, and other activities that may “stir up dust.” This area is located directly outside of the buffer area, where the handwashing and garbing procedure should be performed. The air in this room, or area, is considered an ISO Class 8 environment, which means that the air contains 100,000 particles of 0.5 microns per cubic meter or less. Cartons and packaged compounded supplies (such as needles, syringes, IV bags, and tubing sets) should be unpacked and wiped down with sterile 70% alcohol before passing on to the buffer area when possible.

Buffer area (clean room) or ISO class 7 environment

The buffer area is the main compounding area where primary engineering controls (PECs) are located. This room is where the actual aseptic manipulations of CSPs take place, and it should be located out of the flow of traffic and have limited personnel access. Opening of cartons and boxes or supplies should take place prior to entering this area to reduce the amount of dust particles and ensure a clean product. The buffer area is known as an ISO Class 7 environment, which means that the air contains no more than 10,000 particles of 0.5 microns per cubic meter or less.

Direct compounding area or iso class 5 environment

The most common types of PECs are horizontal or vertical flow hoods. This critical area includes the laminar airflow workbench (LAFW) and the biological safety cabinet (BSC), and it is also commonly referred to as the direct compounding area (DCA). The air in this environment is considered an ISO Class 5 environment, or Class 100. This indicates that the air contains no more than 100 particles of 0.5 microns per cubic meter or less. The microorganisms in this area are monitored regularly to ensure that the level of contaminates in the air, on the surfaces, and on the personnel gear do not exceed the specified cleanliness class.

Access to the IV areas should be limited to only essential personnel. Doors should remain closed at all times, and no food or drink is ever allowed in these areas, including gum chewing! Avoid coughing, sneezing, and excessive talking in the clean room to avoid adding any additional contaminates to the area. Jewelry and cosmetics are restricted upon entry into the ante area according to the current USP 797 guidelines. Artificial nails or extenders are also prohibited while working in the sterile area, and fingernails should be natural and kept trimmed and neat. Additionally, no shipping or external cartons should ever be in the buffer area (also known as the clean room).

Laminar airflow workbench and biological safety cabinet

The LAFW or BSC are both areas that provide a Class 5 environment for aseptic preparation inside the buffer area (Figure 6-2).

LAFWs should be placed out of the traffic flow and are the cleanest work surface in the system. The most important part of this “hood,” as it is sometimes referred to, is the special filter known as a high-efficiency particulate air (HEPA) filter. The filter should never be touched, cleaned, or sprayed with alcohol.

Sitting in front of the LAFW is like sitting in front of a fan blowing wind in your face. The air, known as critical air, enters the prefilter at the front of the hood, travels through the HEPA filter at the back where bacteria and other air contaminants are removed, and then flows horizontally across the work surface (Figure 6-3). This allows purified air to circulate from the back to the front constantly in parallel lines. The air space inside the LAFW is the area known as the DCA. This is where exposure to HEPA-filtered air, or first air, occurs when preparing aseptic preparations. Critical sites (such as the tops of vials and needle surfaces) should always be exposed to first air to avoid contamination from particles allowed to linger in the air. Surfaces (such as needles, syringe plungers, or vial tops) should be exposed to first air at all times.

Observe the following guidelines when working in the LAFW:

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