1. What is the proper method for disinfecting vials before
withdrawing a sterile preparation?
A. Wipe the vial with soap and water
B. Wipe the vial with a 70% IPA swab before accessing the vial
C. Wipe the vial with a bleach solution
D. No need to disinfect the vial
Answer: B) Wipe the vial with a 70% IPA swab before accessing
the vial
Rationale: Disinfecting vials with IPA before use minimizes the
risk of contamination from microorganisms on the vial's surface.
2. What is the recommended method for testing the performance
of a laminar airflow workbench (LAFW)?
A. Perform a smoke test and particle count at regular intervals
B. Test only the airflow speed
C. Test the temperature control system only
D. Test only after the initial installation
Answer: A) Perform a smoke test and particle count at regular
intervals
,Rationale: Regular testing, including smoke and particle count
tests, ensures that the LAFW is operating at optimal conditions to
maintain sterility during compounding.
3. Which of the following is required when preparing compounded
sterile preparations that involve hazardous drugs?
A. Preparing them in a Class II biological safety cabinet (BSC)
B. Preparing them in an open-air environment
C. Preparing them in a non-sterile hood
D. Preparing them in a laminar airflow workbench
Answer: A) Preparing them in a Class II biological safety cabinet
(BSC)
Rationale: Hazardous drugs must be compounded in a Class II
BSC, which provides both containment and sterility assurance to
protect the compounding personnel and the environment.
4. What is the primary purpose of a closed-system drug transfer
device (CSTD)?
A. To prevent drug evaporation
B. To protect compounding personnel from hazardous drug
exposure
C. To maintain sterility during the transfer process
D. To prevent drug incompatibilities
, Answer: B) To protect compounding personnel from hazardous
drug exposure
Rationale: A CSTD is designed to prevent the release of hazardous
drugs into the air, protecting personnel from exposure.
5. 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.
6. 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
withdrawing a sterile preparation?
A. Wipe the vial with soap and water
B. Wipe the vial with a 70% IPA swab before accessing the vial
C. Wipe the vial with a bleach solution
D. No need to disinfect the vial
Answer: B) Wipe the vial with a 70% IPA swab before accessing
the vial
Rationale: Disinfecting vials with IPA before use minimizes the
risk of contamination from microorganisms on the vial's surface.
2. What is the recommended method for testing the performance
of a laminar airflow workbench (LAFW)?
A. Perform a smoke test and particle count at regular intervals
B. Test only the airflow speed
C. Test the temperature control system only
D. Test only after the initial installation
Answer: A) Perform a smoke test and particle count at regular
intervals
,Rationale: Regular testing, including smoke and particle count
tests, ensures that the LAFW is operating at optimal conditions to
maintain sterility during compounding.
3. Which of the following is required when preparing compounded
sterile preparations that involve hazardous drugs?
A. Preparing them in a Class II biological safety cabinet (BSC)
B. Preparing them in an open-air environment
C. Preparing them in a non-sterile hood
D. Preparing them in a laminar airflow workbench
Answer: A) Preparing them in a Class II biological safety cabinet
(BSC)
Rationale: Hazardous drugs must be compounded in a Class II
BSC, which provides both containment and sterility assurance to
protect the compounding personnel and the environment.
4. What is the primary purpose of a closed-system drug transfer
device (CSTD)?
A. To prevent drug evaporation
B. To protect compounding personnel from hazardous drug
exposure
C. To maintain sterility during the transfer process
D. To prevent drug incompatibilities
, Answer: B) To protect compounding personnel from hazardous
drug exposure
Rationale: A CSTD is designed to prevent the release of hazardous
drugs into the air, protecting personnel from exposure.
5. 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.
6. 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
