CETA Study Guide LATEST
B. 2 Liter - ANSWERS-Minimum sampling volume of air during
particle counting shall be?
A. 10 CFM
B. 2 Liter
C. 6M^3
D. None of the above
C. 1 minute - ANSWERS-Minimum time per sample per location during
particle counting shall be?
A. 2 Minutes
B. 90 Seconds
C. 1 Minute
D. 59 Seconds
A. Work Plane - ANSWERS-Particle Counter Probe shall be where
when testing?
A. Work Plane
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B. 26" above floor
C. Shoulder Height
D. 3 " Above Particle Counter
D. Into Airflow - ANSWERS-Particle Counting Sampling Probe shall be
oriented in which direction, when airflow direction is known?
A. Perpendicular to Airflow
B. Downward
C. Vertically Upward
D. Into Airflow
C. Vertically Upward - ANSWERS-When airflow direction is unknown
or not controlled, which orientation shall the particle counting probe be
positioned?
A. Perpendicular to Airflow
B. Downward
C. Vertically Upward
D. None of the above
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A. True - ANSWERS-If an out-of-specification count is found at a
location due to an identified abnormal occurrence, then that count can be
discarded and noted as such on the test report and new sample taken.
A. True
B. False
A. True - ANSWERS-Critical Site is defined as:
"A location that includes any component or fluid pathway surfaces (e.g.
vial septa, injection ports, beakers) or openings (e.g. opened ampule.
needle hubs) exposed and at risk of direct contact with air (e.g. ambient
room or HEPA filtered), moisture (e.g. oral and mucosal secretions), or
touch contamination. Risk of microbial particulate contamination of the
critical site increases with the size of the openings and exposure time"
A. True
B. False
A. True - ANSWERS-Unidirectional Airflow is defined as:
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" An airflow moving in a single direction in a robust and uniform
manner and at a sufficient speed to reproducibly sweep particles away
from the critical processing or testing area"
A. True
B. False
C. 3% or +/- 3 FPM whichever is greater - ANSWERS-A thermal
Anemometer is required to have an accuracy of what percentage?
A. 2% or +/- 2 FPM whichever is greater
B. 1% or +/- 1 FPM whichever is greater
C. 3% or +/- 3 FPM whichever is greater
D. 5% or +/- 5 FPM whichever is greater
A. True - ANSWERS-An Aerosol Photometer, as per CETA, should
have the following parameters:
" A calibrated Aerosol Photometer capable of indicting 100% upstream
concentration with an aerosol of between 10 and 90 µg/L of
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B. 2 Liter - ANSWERS-Minimum sampling volume of air during
particle counting shall be?
A. 10 CFM
B. 2 Liter
C. 6M^3
D. None of the above
C. 1 minute - ANSWERS-Minimum time per sample per location during
particle counting shall be?
A. 2 Minutes
B. 90 Seconds
C. 1 Minute
D. 59 Seconds
A. Work Plane - ANSWERS-Particle Counter Probe shall be where
when testing?
A. Work Plane
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B. 26" above floor
C. Shoulder Height
D. 3 " Above Particle Counter
D. Into Airflow - ANSWERS-Particle Counting Sampling Probe shall be
oriented in which direction, when airflow direction is known?
A. Perpendicular to Airflow
B. Downward
C. Vertically Upward
D. Into Airflow
C. Vertically Upward - ANSWERS-When airflow direction is unknown
or not controlled, which orientation shall the particle counting probe be
positioned?
A. Perpendicular to Airflow
B. Downward
C. Vertically Upward
D. None of the above
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A. True - ANSWERS-If an out-of-specification count is found at a
location due to an identified abnormal occurrence, then that count can be
discarded and noted as such on the test report and new sample taken.
A. True
B. False
A. True - ANSWERS-Critical Site is defined as:
"A location that includes any component or fluid pathway surfaces (e.g.
vial septa, injection ports, beakers) or openings (e.g. opened ampule.
needle hubs) exposed and at risk of direct contact with air (e.g. ambient
room or HEPA filtered), moisture (e.g. oral and mucosal secretions), or
touch contamination. Risk of microbial particulate contamination of the
critical site increases with the size of the openings and exposure time"
A. True
B. False
A. True - ANSWERS-Unidirectional Airflow is defined as:
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" An airflow moving in a single direction in a robust and uniform
manner and at a sufficient speed to reproducibly sweep particles away
from the critical processing or testing area"
A. True
B. False
C. 3% or +/- 3 FPM whichever is greater - ANSWERS-A thermal
Anemometer is required to have an accuracy of what percentage?
A. 2% or +/- 2 FPM whichever is greater
B. 1% or +/- 1 FPM whichever is greater
C. 3% or +/- 3 FPM whichever is greater
D. 5% or +/- 5 FPM whichever is greater
A. True - ANSWERS-An Aerosol Photometer, as per CETA, should
have the following parameters:
" A calibrated Aerosol Photometer capable of indicting 100% upstream
concentration with an aerosol of between 10 and 90 µg/L of
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