Question

question 106

a pharmacy technician should recognize that a compounding aseptic isolator (cai) differs from a standard laminar airflow workbench (lafw) in which of the following ways?

• the cai is used only for non-sterile compounding.
• the cai is designed for use in unclassified room environments without any restrictions.
• the cai does not require hepa filtration.
• the cai provides a fully enclosed, glove-port system that isolates the work area from the external environment.

Explanation:

Compare CAI and LAFW designs

Using the Laminar Airflow Hood and Sterile Compounding knowledge points

• A standard Laminar Airflow Workbench (LAFW) is an open-front hood that relies on a continuous sweep of HEPA-filtered air to protect the compounding area, but it remains open to the cleanroom environment.
• A Compounding Aseptic Isolator (CAI) is a closed barrier system. It is fully enclosed, and compounding is performed through physical glove ports, which completely isolates the internal sterile environment from the external room air.

Evaluate the given options

• Option 1: "The CAI is used only for non-sterile compounding." This is incorrect; CAIs are specifically designed for sterile compounding.
• Option 2: "The CAI is designed for use in unclassified room environments without any restrictions." This is incorrect; while CAIs provide isolation, USP <797> still places specific requirements and restrictions on where they can be placed to maintain sterility.
• Option 3: "The CAI does not require HEPA filtration." This is incorrect; CAIs rely heavily on HEPA-filtered unidirectional airflow to maintain ISO Class 5 air quality inside the chamber.
• Option 4: "The CAI provides a fully enclosed, glove-port system that isolates the work area from the external environment." This is correct and describes the primary physical difference between a CAI and an open LAFW.

Answer:

• (A) The CAI is used only for non-sterile compounding.
• (B) The CAI is designed for use in unclassified room environments without any restrictions.
• (C) The CAI does not require HEPA filtration.
• (D) The CAI provides a fully enclosed, glove-port system that isolates the work area from the external environment. (Correct answer)