1. What is the maximum allowed number of personnel in a sterile
compounding environment at any given time?
A. Only one
B. Two, with proper clearance
C. Three or more, depending on the area size
D. No limit
Answer: C) Three or more, depending on the area size
Rationale: The number of personnel allowed in a sterile
compounding area depends on the space available and the ability
to maintain a sterile environment without causing disruptions to
airflow or cleanliness.
2. Which of the following is NOT a required characteristic of a
sterile compounding area according to USP <797>?
A. Positive air pressure
B. Smooth, non-porous surfaces
C. Room temperature above 25°C
D. Separate hand-washing facilities
Answer: C) Room temperature above 25°C
Rationale: USP <797> requires that the compounding area
maintain positive air pressure and smooth, non-porous surfaces.
,However, the room temperature should ideally be controlled and
not necessarily above 25°C.
3. What is the primary purpose of a sterile compounding facility’s
quality assurance program?
A. To increase employee training
B. To improve patient satisfaction
C. To ensure sterility and prevent contamination of preparations
D. To streamline the compounding process
Answer: C) To ensure sterility and prevent contamination of
preparations
Rationale: A quality assurance program ensures that all processes,
equipment, and procedures meet standards that prevent
contamination and ensure the safety of the compounded
preparations.
4. How should compounding personnel manage contamination
when performing sterile compounding in the cleanroom?
A. By cleaning all surfaces with a bleach solution
B. By immediately disposing of contaminated materials and re-
sanitizing
C. By allowing contamination to air dry before cleaning
D. By ignoring minor contamination
, Answer: B) By immediately disposing of contaminated materials
and re-sanitizing
Rationale: Immediate action should be taken to dispose of
contaminated materials and re-sanitize affected areas to prevent
the spread of contamination in the cleanroom.
5. What is the required temperature range for storing sterile
compounded preparations?
A. 15-25°C
B. 2-8°C
C. 20-25°C
D. 10-20°C
Answer: B) 2-8°C
Rationale: Sterile compounded preparations requiring
refrigeration should be stored at temperatures between 2°C and
8°C to ensure stability and prevent degradation.
6. Which type of equipment is typically used for the sterilization
of compounded sterile preparations?
A. A biological safety cabinet (BSC)
B. A microwave oven
C. An autoclave
D. A UV light chamber
compounding environment at any given time?
A. Only one
B. Two, with proper clearance
C. Three or more, depending on the area size
D. No limit
Answer: C) Three or more, depending on the area size
Rationale: The number of personnel allowed in a sterile
compounding area depends on the space available and the ability
to maintain a sterile environment without causing disruptions to
airflow or cleanliness.
2. Which of the following is NOT a required characteristic of a
sterile compounding area according to USP <797>?
A. Positive air pressure
B. Smooth, non-porous surfaces
C. Room temperature above 25°C
D. Separate hand-washing facilities
Answer: C) Room temperature above 25°C
Rationale: USP <797> requires that the compounding area
maintain positive air pressure and smooth, non-porous surfaces.
,However, the room temperature should ideally be controlled and
not necessarily above 25°C.
3. What is the primary purpose of a sterile compounding facility’s
quality assurance program?
A. To increase employee training
B. To improve patient satisfaction
C. To ensure sterility and prevent contamination of preparations
D. To streamline the compounding process
Answer: C) To ensure sterility and prevent contamination of
preparations
Rationale: A quality assurance program ensures that all processes,
equipment, and procedures meet standards that prevent
contamination and ensure the safety of the compounded
preparations.
4. How should compounding personnel manage contamination
when performing sterile compounding in the cleanroom?
A. By cleaning all surfaces with a bleach solution
B. By immediately disposing of contaminated materials and re-
sanitizing
C. By allowing contamination to air dry before cleaning
D. By ignoring minor contamination
, Answer: B) By immediately disposing of contaminated materials
and re-sanitizing
Rationale: Immediate action should be taken to dispose of
contaminated materials and re-sanitize affected areas to prevent
the spread of contamination in the cleanroom.
5. What is the required temperature range for storing sterile
compounded preparations?
A. 15-25°C
B. 2-8°C
C. 20-25°C
D. 10-20°C
Answer: B) 2-8°C
Rationale: Sterile compounded preparations requiring
refrigeration should be stored at temperatures between 2°C and
8°C to ensure stability and prevent degradation.
6. Which type of equipment is typically used for the sterilization
of compounded sterile preparations?
A. A biological safety cabinet (BSC)
B. A microwave oven
C. An autoclave
D. A UV light chamber
