Cleanroom Facilities and Equipment Flashcards

According to USP Chapter , which of the following is the minimum ISO classification required for a buffer area where non-hazardous sterile compounding is performed?

Answer: ISO Class 7

USP Chapter mandates that the buffer area, which houses the Primary Engineering Controls (PECs), must maintain at least an ISO Class 7 air quality to minimize the risk of contamination to compounded sterile preparations.

A technician is preparing to clean a horizontal laminar airflow workbench (LAFW) at the beginning of their shift. To maintain asepsis, which surface should be cleaned FIRST?

Answer: The IV bar and hooks, from top to bottom

Cleaning should proceed from the cleanest areas to the dirtiest and in a manner that follows the airflow. In a horizontal LAFW, the 'first air' comes from the back HEPA filter. Therefore, cleaning should start with the area closest to the filter, which is the IV bar and hooks, and proceed from top to bottom and back to front.

Which of the following pieces of equipment is classified as a Primary Engineering Control (PEC)?

Answer: A Compounding Aseptic Isolator (CAI)

A Primary Engineering Control (PEC) is a device that provides an ISO Class 5 environment for sterile compounding. A Compounding Aseptic Isolator (CAI) is a type of PEC, along with Laminar Airflow Workbenches (LAFWs) and Biological Safety Cabinets (BSCs). The other options are support equipment found within the cleanroom suite but are not PECs.

In a non-hazardous sterile compounding cleanroom suite, what is the primary reason for maintaining a positive pressure differential between the buffer area and the ante-area?

Answer: To prevent airborne contaminants from entering the cleaner buffer area

Positive pressure ensures that air flows from cleaner spaces (the buffer area) to less clean spaces (the ante-area). This airflow pattern acts as a barrier, preventing particles and microorganisms from the ante-area from entering the critical buffer area where compounding occurs.

During routine monthly cleaning of the sterile compounding areas, which type of agent must be used in addition to a standard disinfectant?

Answer: A sporicidal agent

USP requires the use of a sporicidal agent at least monthly to eliminate bacterial and fungal spores, which are more resistant than vegetative bacteria and may not be killed by standard disinfectants like sterile 70% isopropyl alcohol.

A technician is working with a hazardous drug inside a Compounding Aseptic Containment Isolator (CACI). Which feature is essential for this type of Primary Engineering Control to protect the technician?

Answer: Negative air pressure relative to the surrounding room

A Compounding Aseptic Containment Isolator (CACI) is used for hazardous drugs and must maintain negative air pressure. This ensures that in the event of a breach, air from the surrounding room flows into the isolator, preventing hazardous drug particles or vapors from escaping into the cleanroom and protecting the compounder.