CSPT - Compounded Sterile Preparation Technician Cleanroom Facilities and Equipment Questions and Answers

Question 1

According to USP Chapter <797>, which of the following is the minimum ISO classification required for a buffer area where non-hazardous sterile compounding is performed?

Accepted Answer

ISO Class 7

Answer

ISO Class 5

Answer

ISO Class 8

Answer

ISO Class 9

Question 2

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?

Accepted Answer

The IV bar and hooks, from top to bottom

Answer

The side walls, from bottom to top

Answer

The stainless steel work surface, from back to front

Answer

The protective front shield

Question 3

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

Accepted Answer

A Compounding Aseptic Isolator (CAI)

Answer

A pass-through chamber

Answer

An automated compounding device (ACD)

Answer

A cleanroom refrigerator

Question 4

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?

Accepted Answer

To prevent airborne contaminants from entering the cleaner buffer area

Answer

To reduce energy consumption of the HVAC system

Answer

To ensure easier opening and closing of doors

Answer

To concentrate the effectiveness of cleaning agents

Question 5

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

Accepted Answer

A sporicidal agent

Answer

Sterile water

Answer

A chelating agent

Answer

A neutralizing agent

Question 6

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?

Accepted Answer

Negative air pressure relative to the surrounding room

Answer

Positive air pressure relative to the surrounding room

Answer

A heated work surface to vaporize spills

Answer

Unidirectional vertical airflow only

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?