CSPT 797 Study Set 2 With All Correct & 100% Verified
Answers |Already Graded A+
a system of procedures, activities, and oversight that ensures the compounding process
consistently meets quality standards ✔Correct Answer-Quality Assurance
Sampling, testing, and documentation of results that, taken together, ensure that specifications
have been met before release of the CSP ✔Correct Answer-Quality Control
The probability of an item being nonsterile after it has been exposed to a verified sterilization
process. Can only be applied to terminal sterilization ✔Correct Answer-PNSU
Passage of a gas or liquid through a sterilizing-grade membrane to yield filtrates that are sterile
✔Correct Answer-Sterilization by Filtration
Application of a lethal process (steam, dry heat, irradiation) to sealed containers for the purpose
of achieving a PNSU of greater than 10^-6 (probability of less than 1 in 1 million of a nonsterile
unit) ✔Correct Answer-Terminal Sterilization
a test used in ISO 7 and 8 rooms that do not have unidirectional airflow, in which a visible
source of smoke is used to verify an absence of stagnant airflow. Does not need to be
performed under dynamic operating conditions. ✔Correct Answer-Visual Smoke Study
SDA ✔Correct Answer-Sabouraud Dextrose Agar
Added to inhibit microbial growth ✔Correct Answer-Preservative
A quality documentary standard with USP-NF that articulates the quality expectations for a
medicine. ✔Correct Answer-Monograph
A test (bubble point test) of the integrity of a sterilizing grade filter performed after the filtration
process to detect whether the integrity of the filter had been compromised ✔Correct Answer-
Filter Integrity Test
ECV ✔Correct Answer-Endotoxin Challenge Vial
Non classified enclosure that uses ventilation principles to capture, contain, and remove
airborne contaminants through HEPA filtration and prevent their release into the work
environment ✔Correct Answer-Containment Ventilated Enclosure (CVE)
Answers |Already Graded A+
a system of procedures, activities, and oversight that ensures the compounding process
consistently meets quality standards ✔Correct Answer-Quality Assurance
Sampling, testing, and documentation of results that, taken together, ensure that specifications
have been met before release of the CSP ✔Correct Answer-Quality Control
The probability of an item being nonsterile after it has been exposed to a verified sterilization
process. Can only be applied to terminal sterilization ✔Correct Answer-PNSU
Passage of a gas or liquid through a sterilizing-grade membrane to yield filtrates that are sterile
✔Correct Answer-Sterilization by Filtration
Application of a lethal process (steam, dry heat, irradiation) to sealed containers for the purpose
of achieving a PNSU of greater than 10^-6 (probability of less than 1 in 1 million of a nonsterile
unit) ✔Correct Answer-Terminal Sterilization
a test used in ISO 7 and 8 rooms that do not have unidirectional airflow, in which a visible
source of smoke is used to verify an absence of stagnant airflow. Does not need to be
performed under dynamic operating conditions. ✔Correct Answer-Visual Smoke Study
SDA ✔Correct Answer-Sabouraud Dextrose Agar
Added to inhibit microbial growth ✔Correct Answer-Preservative
A quality documentary standard with USP-NF that articulates the quality expectations for a
medicine. ✔Correct Answer-Monograph
A test (bubble point test) of the integrity of a sterilizing grade filter performed after the filtration
process to detect whether the integrity of the filter had been compromised ✔Correct Answer-
Filter Integrity Test
ECV ✔Correct Answer-Endotoxin Challenge Vial
Non classified enclosure that uses ventilation principles to capture, contain, and remove
airborne contaminants through HEPA filtration and prevent their release into the work
environment ✔Correct Answer-Containment Ventilated Enclosure (CVE)
