1. Which of the following is the primary reason for maintaining a
cleanroom environment during sterile compounding?
A) To prevent cross-contamination between drugs
B) To ensure the aesthetic appearance of the preparation
C) To minimize the amount of time spent on preparing the compound
D) To reduce the amount of air conditioning used in the facility
Answer: A) To prevent cross-contamination between drugs
Rationale: A cleanroom environment is essential to minimize the risk
of contamination from microorganisms, particulate matter, and cross-
contamination between drugs, ensuring patient safety.
2. Which of the following is the minimum required air quality
standard for the buffer area in a sterile compounding facility
according to USP <797>?
A) ISO 5
B) ISO 7
C) ISO 8
D) ISO 9
Answer: A) ISO 5
Rationale: The buffer area, where sterile preparations are compounded,
must meet at least ISO 5 air quality standards to ensure a controlled
environment that minimizes contamination.
3. What is the most appropriate method for cleaning a laminar
airflow workbench (LAFW) used for sterile compounding?
A) Clean with soap and water before compounding
B) Clean with 70% isopropyl alcohol (IPA) before and after
compounding
,C) Clean with bleach solution after each use
D) Only clean the LAFW if visibly dirty
Answer: B) Clean with 70% isopropyl alcohol (IPA) before and after
compounding
Rationale: IPA is the recommended cleaning agent because it
effectively disinfects surfaces and reduces the risk of microbial
contamination without leaving residues.
4. When compounding sterile preparations, how often should the
air quality in an ISO 5 environment be monitored?
A) Daily
B) Weekly
C) Monthly
D) Annually
Answer: A) Daily
Rationale: Air quality in an ISO 5 environment should be monitored at
least daily to ensure it meets required standards for particulate and
microbial contamination.
5. Which of the following types of gloves should be worn when
preparing sterile compounds in an ISO 5 environment?
A) Powdered latex gloves
B) Non-sterile nitrile gloves
C) Sterile, non-powdered gloves
D) Sterile cotton gloves
Answer: C) Sterile, non-powdered gloves
Rationale: Sterile, non-powdered gloves are required for compounding
sterile preparations to avoid contamination and minimize the risk of
allergic reactions from powder.
, 6. According to USP <797>, how long should sterile compounding
personnel perform hand hygiene before entering the cleanroom?
A) At least 10 seconds
B) At least 20 seconds
C) At least 30 seconds
D) At least 1 minute
Answer: B) At least 20 seconds
Rationale: Hand hygiene should be performed for at least 20 seconds
to thoroughly cleanse the hands of contaminants before entering the
sterile compounding area.
7. 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.
8. When should a compounding pharmacy use a Class II Biological
Safety Cabinet (BSC)?
A) For preparing non-sterile preparations
B) For preparing sterile preparations with risk of exposure to
hazardous drugs
cleanroom environment during sterile compounding?
A) To prevent cross-contamination between drugs
B) To ensure the aesthetic appearance of the preparation
C) To minimize the amount of time spent on preparing the compound
D) To reduce the amount of air conditioning used in the facility
Answer: A) To prevent cross-contamination between drugs
Rationale: A cleanroom environment is essential to minimize the risk
of contamination from microorganisms, particulate matter, and cross-
contamination between drugs, ensuring patient safety.
2. Which of the following is the minimum required air quality
standard for the buffer area in a sterile compounding facility
according to USP <797>?
A) ISO 5
B) ISO 7
C) ISO 8
D) ISO 9
Answer: A) ISO 5
Rationale: The buffer area, where sterile preparations are compounded,
must meet at least ISO 5 air quality standards to ensure a controlled
environment that minimizes contamination.
3. What is the most appropriate method for cleaning a laminar
airflow workbench (LAFW) used for sterile compounding?
A) Clean with soap and water before compounding
B) Clean with 70% isopropyl alcohol (IPA) before and after
compounding
,C) Clean with bleach solution after each use
D) Only clean the LAFW if visibly dirty
Answer: B) Clean with 70% isopropyl alcohol (IPA) before and after
compounding
Rationale: IPA is the recommended cleaning agent because it
effectively disinfects surfaces and reduces the risk of microbial
contamination without leaving residues.
4. When compounding sterile preparations, how often should the
air quality in an ISO 5 environment be monitored?
A) Daily
B) Weekly
C) Monthly
D) Annually
Answer: A) Daily
Rationale: Air quality in an ISO 5 environment should be monitored at
least daily to ensure it meets required standards for particulate and
microbial contamination.
5. Which of the following types of gloves should be worn when
preparing sterile compounds in an ISO 5 environment?
A) Powdered latex gloves
B) Non-sterile nitrile gloves
C) Sterile, non-powdered gloves
D) Sterile cotton gloves
Answer: C) Sterile, non-powdered gloves
Rationale: Sterile, non-powdered gloves are required for compounding
sterile preparations to avoid contamination and minimize the risk of
allergic reactions from powder.
, 6. According to USP <797>, how long should sterile compounding
personnel perform hand hygiene before entering the cleanroom?
A) At least 10 seconds
B) At least 20 seconds
C) At least 30 seconds
D) At least 1 minute
Answer: B) At least 20 seconds
Rationale: Hand hygiene should be performed for at least 20 seconds
to thoroughly cleanse the hands of contaminants before entering the
sterile compounding area.
7. 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.
8. When should a compounding pharmacy use a Class II Biological
Safety Cabinet (BSC)?
A) For preparing non-sterile preparations
B) For preparing sterile preparations with risk of exposure to
hazardous drugs
