CETa LATEST 2026 END OF COURSE QUESTIONS AND
ANSWERS GRADED A+
✔✔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).]
✔✔Placement of LAFS - ✔✔The LAFS must be located out of traffic patterns and away
from room air currents that could disrupt the intended airflow patterns inside the PEC. If
used to prepare only Category 1 CSPs, the ISO Class 5 PEC may be located in an
unclassified SCA. If used to prepare Category 2 or Category 3 CSPs, the LAFS must be
located within a cleanroom suite with an ISO Class 7 or better buffer room with an ISO
Class 8 or better anteroom. A dynamic airflow smoke pattern test must be performed in
the PEC initially and at least every 6 months to ensure that 1) the LAFS is properly
placed into the facility and 2) compounders understand how to utilize the unidirectional
airflow to maintain first air in the DCA.
✔✔RABS - ✔✔restricted access barrier system
,✔✔What is a Restricted-access barrier system? - ✔✔A RABS is an enclosure that
provides HEPA-filtered ISO Class 5 unidirectional air. It allows for the ingress and/or
egress of materials through defined openings that have been designed and validated to
preclude the transfer of environmental air contamination and are generally not to be
opened during compounding operations. RABS include compounding aseptic isolators
(CAIs) and compounding aseptic containment isolators (CACIs). In a CAI or CACI,
glove ports are used to provide physical separation between the surrounding area and
the aseptic manipulations.
✔✔Compounding Aseptic Isolator (CAI) - ✔✔A CAI is designed for compounding non-
HD CSPs. It is designed to maintain an ISO Class 5 environment throughout the
compounding and material transfer processes. Air exchange into the CAI from the
surrounding environment must not occur unless the air has first passed through a HEPA
filter.
✔✔Compounding Aseptic Containment Isolator (CACI) - ✔✔A CACI is designed to
provide worker protection from exposure to undesirable levels of airborne drug
throughout the compounding and material transfer processes and to maintain an ISO
Class 5 environment for compounding sterile HD preparations
✔✔Placement of RABS - ✔✔If used to prepare only Category 1 CSPs, the ISO Class 5
environment may be achieved by placing the RABS in an unclassified SCA. If used to
prepare Category 2 or Category 3 CSPs, the RABS must be located within a cleanroom
suite with an ISO Class 7 or better buffer room with an ISO Class 8 or better anteroom.
For placement of a CACI used for the preparation of antineoplastic and/or API HDs, see
á800ñ
✔✔Pharmaceutical isolator - ✔✔A pharmaceutical isolator provides isolation from the
surrounding area and maintains ISO Class 5 air quality during dynamic operating
conditions. [NOTE—A CAI or CACI is not a pharmaceutical isolator.]
A pharmaceutical isolator comprises four elements:
1. Controlled workspace
2. Transfer device(s)
3. Access device(s)
4. Integral decontamination system
✔✔Placement of pharmaceutical isolators - ✔✔A pharmaceutical isolator used to
prepare only Category 1 CSPs can be placed in an unclassified SCA. If the
pharmaceutical isolator is used to prepare Category 2 or Category 3 CSPs, the
pharmaceutical isolator must be placed in an ISO Class 8 or better room. [NOTE—An
anteroom is not required when using a pharmaceutical isolator.] A dynamic airflow
smoke pattern test must be performed in the PEC initially and at least every 6 months to
ensure that 1) the pharmaceutical isolator is properly placed in the facility and 2)
, compounders understand how to utilize the unidirectional airflow to maintain first air in
the work zone.
✔✔What are the requirements if a robotic enclosure is used in a PEC? - ✔✔a dynamic
airflow smoke pattern test must be performed initially and at least every 6 months
thereafter to ensure that 1) it is properly integrated into the facility, 2) there is no
turbulence or refluxing at any critical site(s), 3) room air does not enter the PEC where
sterile products and/or preparations may be exposed, and 4) all processes can be
performed without introducing contamination to the DCA(s).
✔✔How is airflow measured in a cleanroom? - ✔✔Airflow is measured in terms of the
number of air changes per hour (ACPH)
✔✔What are factors that may require higher ACPH to maintain the ISO requirements? -
✔✔Number of personnel permitted to work in the area
Number of particles that may be generated from activities and processes in the area
Equipment located in the room
Room pressure
✔✔How many air changes per hour for ISO 7 Class rooms? - ✔✔Minimum of 30 HEPA
Filtered air changes per hour
The total HEPA filtered ACPH must be adequate to maintain ISO 7 during dynamic
operations conditions.
At least 15 ACPH of the total air changes rate in a room must come from the HVAC
HEPA filters located in the ceiling
The HEPA-filtered air from the PEC, when added to the HVAC-supplied HEPA-filtered
air, must increase the total HEPA-filtered ACPH to at least 30 ACPH
If the PEC is used to meet the minimum total ACPH requirements, the PEC must not be
turned off except for maintenance
Rooms where activity levels are high may require more HEPA-filtered ACPH to maintain
ISO Class 7 air quality under dynamic operating conditions
The ACPH from HVAC, ACPH contributed from the PEC, and the total ACPH must be
documented on the certification report
✔✔How many air changes per hour for ISO 8 Class Rooms? - ✔✔The total HEPA-
filtered air change rate must be adequate to maintain ISO Class 8 under dynamic
operating conditions considering the factors listed above
ANSWERS GRADED A+
✔✔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).]
✔✔Placement of LAFS - ✔✔The LAFS must be located out of traffic patterns and away
from room air currents that could disrupt the intended airflow patterns inside the PEC. If
used to prepare only Category 1 CSPs, the ISO Class 5 PEC may be located in an
unclassified SCA. If used to prepare Category 2 or Category 3 CSPs, the LAFS must be
located within a cleanroom suite with an ISO Class 7 or better buffer room with an ISO
Class 8 or better anteroom. A dynamic airflow smoke pattern test must be performed in
the PEC initially and at least every 6 months to ensure that 1) the LAFS is properly
placed into the facility and 2) compounders understand how to utilize the unidirectional
airflow to maintain first air in the DCA.
✔✔RABS - ✔✔restricted access barrier system
,✔✔What is a Restricted-access barrier system? - ✔✔A RABS is an enclosure that
provides HEPA-filtered ISO Class 5 unidirectional air. It allows for the ingress and/or
egress of materials through defined openings that have been designed and validated to
preclude the transfer of environmental air contamination and are generally not to be
opened during compounding operations. RABS include compounding aseptic isolators
(CAIs) and compounding aseptic containment isolators (CACIs). In a CAI or CACI,
glove ports are used to provide physical separation between the surrounding area and
the aseptic manipulations.
✔✔Compounding Aseptic Isolator (CAI) - ✔✔A CAI is designed for compounding non-
HD CSPs. It is designed to maintain an ISO Class 5 environment throughout the
compounding and material transfer processes. Air exchange into the CAI from the
surrounding environment must not occur unless the air has first passed through a HEPA
filter.
✔✔Compounding Aseptic Containment Isolator (CACI) - ✔✔A CACI is designed to
provide worker protection from exposure to undesirable levels of airborne drug
throughout the compounding and material transfer processes and to maintain an ISO
Class 5 environment for compounding sterile HD preparations
✔✔Placement of RABS - ✔✔If used to prepare only Category 1 CSPs, the ISO Class 5
environment may be achieved by placing the RABS in an unclassified SCA. If used to
prepare Category 2 or Category 3 CSPs, the RABS must be located within a cleanroom
suite with an ISO Class 7 or better buffer room with an ISO Class 8 or better anteroom.
For placement of a CACI used for the preparation of antineoplastic and/or API HDs, see
á800ñ
✔✔Pharmaceutical isolator - ✔✔A pharmaceutical isolator provides isolation from the
surrounding area and maintains ISO Class 5 air quality during dynamic operating
conditions. [NOTE—A CAI or CACI is not a pharmaceutical isolator.]
A pharmaceutical isolator comprises four elements:
1. Controlled workspace
2. Transfer device(s)
3. Access device(s)
4. Integral decontamination system
✔✔Placement of pharmaceutical isolators - ✔✔A pharmaceutical isolator used to
prepare only Category 1 CSPs can be placed in an unclassified SCA. If the
pharmaceutical isolator is used to prepare Category 2 or Category 3 CSPs, the
pharmaceutical isolator must be placed in an ISO Class 8 or better room. [NOTE—An
anteroom is not required when using a pharmaceutical isolator.] A dynamic airflow
smoke pattern test must be performed in the PEC initially and at least every 6 months to
ensure that 1) the pharmaceutical isolator is properly placed in the facility and 2)
, compounders understand how to utilize the unidirectional airflow to maintain first air in
the work zone.
✔✔What are the requirements if a robotic enclosure is used in a PEC? - ✔✔a dynamic
airflow smoke pattern test must be performed initially and at least every 6 months
thereafter to ensure that 1) it is properly integrated into the facility, 2) there is no
turbulence or refluxing at any critical site(s), 3) room air does not enter the PEC where
sterile products and/or preparations may be exposed, and 4) all processes can be
performed without introducing contamination to the DCA(s).
✔✔How is airflow measured in a cleanroom? - ✔✔Airflow is measured in terms of the
number of air changes per hour (ACPH)
✔✔What are factors that may require higher ACPH to maintain the ISO requirements? -
✔✔Number of personnel permitted to work in the area
Number of particles that may be generated from activities and processes in the area
Equipment located in the room
Room pressure
✔✔How many air changes per hour for ISO 7 Class rooms? - ✔✔Minimum of 30 HEPA
Filtered air changes per hour
The total HEPA filtered ACPH must be adequate to maintain ISO 7 during dynamic
operations conditions.
At least 15 ACPH of the total air changes rate in a room must come from the HVAC
HEPA filters located in the ceiling
The HEPA-filtered air from the PEC, when added to the HVAC-supplied HEPA-filtered
air, must increase the total HEPA-filtered ACPH to at least 30 ACPH
If the PEC is used to meet the minimum total ACPH requirements, the PEC must not be
turned off except for maintenance
Rooms where activity levels are high may require more HEPA-filtered ACPH to maintain
ISO Class 7 air quality under dynamic operating conditions
The ACPH from HVAC, ACPH contributed from the PEC, and the total ACPH must be
documented on the certification report
✔✔How many air changes per hour for ISO 8 Class Rooms? - ✔✔The total HEPA-
filtered air change rate must be adequate to maintain ISO Class 8 under dynamic
operating conditions considering the factors listed above
