CETa LATEST 2026 EXAMINATION SET QUESTIONS AND
ANSWERS GRADED A+
✔✔Handwashing procedures - ✔✔Clean under fingernails under warm running water
using nail cleaner
Wash hands and forearms up to elbows for 30 s.
Dry hands and forearms up to elbows completely with low-lint disposable towels.
Apply an alcohol-based hand rub to dry skin
Apply product to one hand and rub hands together
Allow hands to dry before donning sterile gloves
✔✔Minimum Garb requirements in category 2 and 3 - ✔✔Low Lint garment with sleves
Low Lint shoe covers
Low Lint cover for head and facial hair
Low Lint face mask
Sterile powder free gloves
If using a RABS disposable gloves should be worn inside the RABS sleeves.
✔✔Additional garbing requirements for category 3 - ✔✔No exposed skin in the buffer
room (face/neck)
All lo-lint outer garb must be sterile, including use of over gauntlet sleeves in the RABS
Disposable garbing items must not be reused, laundered garb must not be reused
without being laundered and re-sterilized with a validated cycle
Facilities SOPs must describe procedures for using goggles, respirators, and other
reusable equipment
✔✔ISO 7 Classification - ✔✔352,000 particle per cubic meter. Limits measured at
greater than 0.5 micrometers under dynamic operating conditions
✔✔ISO 5 Classification - ✔✔3,520 particle count per cubic meter. Limits measured at
greater than 0.5 micrometers under dynamic conditions
,✔✔ISO 8 Classification - ✔✔3,520,000 particle count per cubic meter. Limits measured
at greater than 0.5 micrometers under dynamic conditions
✔✔Design Requirements to maintain air quality <USP 797> - ✔✔Anterooms providing
access to positive-pressure buffer room must meet at least ISO Class 8
Anterooms providing access to negative-pressure buffer rooms must meet at least an
ISO Class 7.
A buffer room must meet at least ISO Class 7 air quality. Activities in the buffer room
must be controlled to minimize any effect on air quality in the are where CSP are
prepared
Category 1, Category 2, and Category 3 CSPs must be compounded in an ISO Class 5
or better PEC. If compounding only Category 1 CSP, the PEC may be placed in a
Segregated Compounding Area
✔✔What temperature and humidity level does the cleanroom suite need to be
maintained? - ✔✔The cleanroom suite should be maintained at a temperature of 20
degrees or cooler and a relative humidity of 60% or below to minimize the risk of
microbial proliferation and provide comfortable conditions for compounding personnel
attired in required garb.
✔✔How often must the temperature and humidity be monitored? - ✔✔The temp and
humidity must be monitored each day that compounding is performed, either manually
or by a continuous recording device.
✔✔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) - ✔✔An IVLFZ is a designated ISO
Class 5 area serving as the PEC within an ISO Class 7 or cleaner buffer room. In the
IVLFZ, unidirectional airflow is created by placing HEPA filters over the entire surface of
the worktables and by effective placement of air returns. The unidirectional HEPA-
filtered zone must be separated from the ISO Class 7 area with a physical barrier to
direct the airflow downward over the work area to separate the DCA from potential
sources of contamination. Strategic location of air returns in addition to full coverage of
HEPA filters above the work surface is required. Both static and dynamic smoke studies
verifying a continuous flow of HEPA-filtered air void of turbulence, dead air zones, and
refluxing from the HEPA filters to and across the entire work area and to the air returns
must be documented (e.g., with video). [NOTE—Dynamic airflow smoke pattern tests
have shown that it is difficult to achieve this type of design and also achieve and
maintain unidirectional airflow under dynamic operating conditions.]
✔✔Class II biological safety cabinet (BSC) - ✔✔A Class II BSC is a ventilated cabinet
with an open front and inward and downward unidirectional HEPA-filtered airflow and
HEPA-filtered exhaust. The BSC is designed to provide worker protection from
exposure to airborne drugs and to provide an ISO Class 5 or better environment for
preparing CSPs. [NOTE—The exhaust air from the BSC must be externally vented for
preparation of antineoplastic and/or API HDs (see á800ñ).]
ANSWERS GRADED A+
✔✔Handwashing procedures - ✔✔Clean under fingernails under warm running water
using nail cleaner
Wash hands and forearms up to elbows for 30 s.
Dry hands and forearms up to elbows completely with low-lint disposable towels.
Apply an alcohol-based hand rub to dry skin
Apply product to one hand and rub hands together
Allow hands to dry before donning sterile gloves
✔✔Minimum Garb requirements in category 2 and 3 - ✔✔Low Lint garment with sleves
Low Lint shoe covers
Low Lint cover for head and facial hair
Low Lint face mask
Sterile powder free gloves
If using a RABS disposable gloves should be worn inside the RABS sleeves.
✔✔Additional garbing requirements for category 3 - ✔✔No exposed skin in the buffer
room (face/neck)
All lo-lint outer garb must be sterile, including use of over gauntlet sleeves in the RABS
Disposable garbing items must not be reused, laundered garb must not be reused
without being laundered and re-sterilized with a validated cycle
Facilities SOPs must describe procedures for using goggles, respirators, and other
reusable equipment
✔✔ISO 7 Classification - ✔✔352,000 particle per cubic meter. Limits measured at
greater than 0.5 micrometers under dynamic operating conditions
✔✔ISO 5 Classification - ✔✔3,520 particle count per cubic meter. Limits measured at
greater than 0.5 micrometers under dynamic conditions
,✔✔ISO 8 Classification - ✔✔3,520,000 particle count per cubic meter. Limits measured
at greater than 0.5 micrometers under dynamic conditions
✔✔Design Requirements to maintain air quality <USP 797> - ✔✔Anterooms providing
access to positive-pressure buffer room must meet at least ISO Class 8
Anterooms providing access to negative-pressure buffer rooms must meet at least an
ISO Class 7.
A buffer room must meet at least ISO Class 7 air quality. Activities in the buffer room
must be controlled to minimize any effect on air quality in the are where CSP are
prepared
Category 1, Category 2, and Category 3 CSPs must be compounded in an ISO Class 5
or better PEC. If compounding only Category 1 CSP, the PEC may be placed in a
Segregated Compounding Area
✔✔What temperature and humidity level does the cleanroom suite need to be
maintained? - ✔✔The cleanroom suite should be maintained at a temperature of 20
degrees or cooler and a relative humidity of 60% or below to minimize the risk of
microbial proliferation and provide comfortable conditions for compounding personnel
attired in required garb.
✔✔How often must the temperature and humidity be monitored? - ✔✔The temp and
humidity must be monitored each day that compounding is performed, either manually
or by a continuous recording device.
✔✔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) - ✔✔An IVLFZ is a designated ISO
Class 5 area serving as the PEC within an ISO Class 7 or cleaner buffer room. In the
IVLFZ, unidirectional airflow is created by placing HEPA filters over the entire surface of
the worktables and by effective placement of air returns. The unidirectional HEPA-
filtered zone must be separated from the ISO Class 7 area with a physical barrier to
direct the airflow downward over the work area to separate the DCA from potential
sources of contamination. Strategic location of air returns in addition to full coverage of
HEPA filters above the work surface is required. Both static and dynamic smoke studies
verifying a continuous flow of HEPA-filtered air void of turbulence, dead air zones, and
refluxing from the HEPA filters to and across the entire work area and to the air returns
must be documented (e.g., with video). [NOTE—Dynamic airflow smoke pattern tests
have shown that it is difficult to achieve this type of design and also achieve and
maintain unidirectional airflow under dynamic operating conditions.]
✔✔Class II biological safety cabinet (BSC) - ✔✔A Class II BSC is a ventilated cabinet
with an open front and inward and downward unidirectional HEPA-filtered airflow and
HEPA-filtered exhaust. The BSC is designed to provide worker protection from
exposure to airborne drugs and to provide an ISO Class 5 or better environment for
preparing CSPs. [NOTE—The exhaust air from the BSC must be externally vented for
preparation of antineoplastic and/or API HDs (see á800ñ).]
