MASTERING THE CETA EXAM 2024-2025: 300 ACTUAL
QUESTIONS WITH CORRECT ANSWERS & IN-DEPTH
RATIONALE
How often do temperature and humidity devices in the cleanroom suites need to be verified for
accuracy?
Every 12 months or verified by the mfg.
Who at the facilities is responsible for ensuring that each area related to CSP preparations meets the
classified air quality standard appropriate for the activities to be conducted in that area?
Designated Person
Where can a PEC be located?
The PEC must be located in the buffer room or SCA in an a manner that minimizes conditions that could
increase the risk of microbial contamination.
Describe a cleanroom suite <USP 797>
The ISO classified anteroom and buffer must be separated from the surrounding unclassified areas of the
facility by fixed walls and doors, and controls must be in place to minimize the flow of lower quality air
into more controlled areas.
The classified rooms must be equipped with pressure-differential monitoring systems.
,Air supplied to the cleanroom suite must be introduced through HEPA filters that are located in the
ceiling of the buffer room and anteroom.
Air returns must be low on the wall unless visual smoke study demonstrates an absence of stagnant
airflow.
The anteroom must have a line of demarcation to separate clean side from the dirty side. The anteroom
is entered from dirty side and the clean side is closest to the buffer room.
It is critical to control materials as they move from classified areas of lower quality to those of higher
quality to minimize the influx of contaminants.
Consider the placement of doors closures, door surfaces, and the movement of the doors, all of which
can affect airflow.
Should seals and sweeps be installed at the doors between buffer rooms and anterooms?
No
Can tacky mats be placed within ISO classified areas?
No
If PECs used for sterile and non-sterile compounding are places in the same room, what is the distance
they need to be apart?
,1 m apart, and particle generating activities must not be performed while sterile compounding is in
process
Do sterile and non-sterile PECs need to be in separate rooms?
They must be in separate rooms unless those PECs are sufficiently effective that the room can
continuously maintain ISO 7
SCA
Segregated compounding area
Describe a SCA according to USP <797>
A PEC may be located within an unclassified area without an anteroom or buffer room
Only Category 1 CSP may be compounded in an SCA
The SCA must be located away from unsealed windows, doors that connect to the outdoors, and traffic
flow, all of which may adversely affect air quality in the PEC
SCA must not be located where environmental control challenges could negatively affect air quality in
the PEC.
The impact of activities what will be conducted around or adjacent to the SCA must be considered when
signing the area.
, The area within 1 m of the PEC should be dedicated only for sterile compounding activities. (not storage,
hand hygiene, donning/doffing garb, or other particle generating activities)
CSP Compounding Environment
The PEC must be certified to meet ISO Class 5 or better conditions during dynamic operating conditions
and must be designed to minimize risk of contamination during compounding of CSPs.
Unidirectional airflow must e maintained in the PEC. HEPA filtered air must be supplied by the PEC at a
velocity sufficient to sweep particles away from the critical sites and maintain unidirectional airflow
during operations.
Laminar airflow system
An LAFS provides an ISO Class 5 or better environment for sterile compounding. The LAFS provides
unidirectional HEPA-filtered airflow that is designed to minimize the risk of contamination of a sterile
compounding environment. The unidirectional airflow within the LAFS helps protect the direct
compounding area (DCA) from process-generated contaminatio
LAFW - Laminar Airflow Workbench
Laminar airflow workbench (LAFW): An LAFW is a device that provides an ISO Class 5 or better
environment for sterile compounding. The LAFW provides either horizontal or vertical unidirectional
HEPA-filtered airflow
IVLFZ
Integrated Vertical Laminar Flow Zone
Integrated Vertical Laminar Flow Zone (IVLFZ)
QUESTIONS WITH CORRECT ANSWERS & IN-DEPTH
RATIONALE
How often do temperature and humidity devices in the cleanroom suites need to be verified for
accuracy?
Every 12 months or verified by the mfg.
Who at the facilities is responsible for ensuring that each area related to CSP preparations meets the
classified air quality standard appropriate for the activities to be conducted in that area?
Designated Person
Where can a PEC be located?
The PEC must be located in the buffer room or SCA in an a manner that minimizes conditions that could
increase the risk of microbial contamination.
Describe a cleanroom suite <USP 797>
The ISO classified anteroom and buffer must be separated from the surrounding unclassified areas of the
facility by fixed walls and doors, and controls must be in place to minimize the flow of lower quality air
into more controlled areas.
The classified rooms must be equipped with pressure-differential monitoring systems.
,Air supplied to the cleanroom suite must be introduced through HEPA filters that are located in the
ceiling of the buffer room and anteroom.
Air returns must be low on the wall unless visual smoke study demonstrates an absence of stagnant
airflow.
The anteroom must have a line of demarcation to separate clean side from the dirty side. The anteroom
is entered from dirty side and the clean side is closest to the buffer room.
It is critical to control materials as they move from classified areas of lower quality to those of higher
quality to minimize the influx of contaminants.
Consider the placement of doors closures, door surfaces, and the movement of the doors, all of which
can affect airflow.
Should seals and sweeps be installed at the doors between buffer rooms and anterooms?
No
Can tacky mats be placed within ISO classified areas?
No
If PECs used for sterile and non-sterile compounding are places in the same room, what is the distance
they need to be apart?
,1 m apart, and particle generating activities must not be performed while sterile compounding is in
process
Do sterile and non-sterile PECs need to be in separate rooms?
They must be in separate rooms unless those PECs are sufficiently effective that the room can
continuously maintain ISO 7
SCA
Segregated compounding area
Describe a SCA according to USP <797>
A PEC may be located within an unclassified area without an anteroom or buffer room
Only Category 1 CSP may be compounded in an SCA
The SCA must be located away from unsealed windows, doors that connect to the outdoors, and traffic
flow, all of which may adversely affect air quality in the PEC
SCA must not be located where environmental control challenges could negatively affect air quality in
the PEC.
The impact of activities what will be conducted around or adjacent to the SCA must be considered when
signing the area.
, The area within 1 m of the PEC should be dedicated only for sterile compounding activities. (not storage,
hand hygiene, donning/doffing garb, or other particle generating activities)
CSP Compounding Environment
The PEC must be certified to meet ISO Class 5 or better conditions during dynamic operating conditions
and must be designed to minimize risk of contamination during compounding of CSPs.
Unidirectional airflow must e maintained in the PEC. HEPA filtered air must be supplied by the PEC at a
velocity sufficient to sweep particles away from the critical sites and maintain unidirectional airflow
during operations.
Laminar airflow system
An LAFS provides an ISO Class 5 or better environment for sterile compounding. The LAFS provides
unidirectional HEPA-filtered airflow that is designed to minimize the risk of contamination of a sterile
compounding environment. The unidirectional airflow within the LAFS helps protect the direct
compounding area (DCA) from process-generated contaminatio
LAFW - Laminar Airflow Workbench
Laminar airflow workbench (LAFW): An LAFW is a device that provides an ISO Class 5 or better
environment for sterile compounding. The LAFW provides either horizontal or vertical unidirectional
HEPA-filtered airflow
IVLFZ
Integrated Vertical Laminar Flow Zone
Integrated Vertical Laminar Flow Zone (IVLFZ)
