CETa EXAM AND PRACTICE EXAM 2024-2025 ACTUAL EXAM 300 QUESTIONS AND CORRECT DETAILED
ANSWERS WITH RATIONALES (VERIFIED ANSWERS)
Designated Persons - ongoing training and competency
Training and Competency in compounding sterile principles - at least every 12 months unless
compounding
Garbing Competency - At least every 12 months unless compounding
Media Fill with Post GFT and Surface sampling -at least every 12 months unless compounding
What are requirements of a C-SEC
externally vented, be physically separated, have appropriate acph, must have a negative pressure
between negative 0.01 and 0.03 inches of water column relative to adjacent areas
Describe an HD sterile compounding setup
Iso Class 7 buffer room with an iso class 7 ante room, C-PEC (externally vented) BSC Class II OR A CACI, C-
SEC is externally vented, 30 ACPH, negative pressure 0.01 to 0.03.
Describe a C-SCA
Containment-Segregated Compounding Area - This is an unclassified space, with an externally vented
BSC Class II or a CACI, negative pressure room 0.01-0.030, 12 ACPH externally vented. BUD is for
category 1 drugs
How far does the sink in an HD ante room need to be away from the entrance to the HD buffer room?
1 meter
What are the requirements if an HD buffer room is entered through a Non-HD buffer room?
Line of Demarcation in the negative room for donning/doffing garb, there must be a method of
transporting HD drugs out of the HD buffer room, i.e. pass thrus.
CSTD
closed system drug transfer device
CSTD definition
A drug-transfer device that mechanically prohibits the transfer of environmental contaminants into the
system and the escape of HD or vapor concentrations outside the system.
What are the 3 engineering controls for HD CSP
Primary, Secondary, Supplemental
Unidirectional Airflow
An airflow moving in a single direction, in a robust and uniform manner, and at sufficient speed to
reproducibly sweep particles away from the critical processing or testing area
,ISO
International Organization for Standardization
As Built
condition where the cleanroom is complete with all services connected and functioning but with no
equipment, furniture, materials or personnel present
at-rest
condition of the cleanroom is complete with equipment installed and operating in a manner agreed
upon, but with no personnel present.
operational condition
agreed condition where the cleanroom is functioning with equipment operating and with specified
number of personnel present
How is particle size measured?
numbers of particles per cubic meter
LSAPC
Light Scattering Airborne Particle Counter
PAO
Polyalphaolefin
Visual Smoke Study
A test, used in ISO Class 7 and ISO Class 8 rooms that do not have unidirectional airflow, in which a
visible source of smoke, which is close to neutrally buoyant, issued to verify an absence of stagnant
airflow where particulates can accumulate. This test does not need to be performed under dynamic
operating conditions and is not appropriate for PECs (see Dynamic airflow smoke pattern test). This test
is done when an ISO Classified room has ceiling mounted air returns. It only needs to be done when the
room is first commissioned and again when any changes to the room configuration which may affect the
room's performance are made.
What apparatus is used for airflow testing in SEC?
A calibrated air multimeter with an accuracy of ± 3% of reading ± 7 CFM (± 12m3 /h), in conjunction
with;
A capture hood with properly sized shroud or a multi-point tube array with proper stand offs (typically
6" (15 cm) are used)
A calibrated thermal anemometer with an accuracy of ± 3 ft/min (± 0.015 m/s) or3% of the indicated
velocity, whichever is larger in conjunction with a rigid probe holder that will not distort airflow
,Non-ISO Classified Negative Pressure Turbulent Airflow Area Testing Procedure
ACPH requirements for containment segregated compounding areas and hazardous drug storage areas,
must be a minimum of 12 exhaust ACPH. Because these rooms/areas are not ISO classified airflow
measurements should be taken on the exhaust of negative pressure differential rooms.
Large Room Calculations for particle counts
M2/1000X27
Air sample conversion if less thant 1000 Liters
Raw Countx1000/sample size taken
What is actual vs standard
Standard is 70 and 14.7 psi at 0 humidity, actual is use actual temp and barometric pressure
ISO Classified Turbulent Airflow Area Reporting and Documentation
8 Minimum Documentations
Record all airflow measurements and their corresponding filter or diffuser locations or grid
identifications on a diagram
Calculate and report room volume
Calculate and report the average total room airflow volume
Calculate and report the total air changes per hour of the room (include LAFW and/or Non-ducted BSC
HEPA exhaust to room, if applicable)
Report any correction factors used or deviations from the primary method
Name of test (e.g., Room Airflow Analysis)
Report acceptance criteria
Provide a Pass or Fail statement based on the results of the test
SEC Airflow Testing Frequency
Airflow testing must be performed at least every six months or after any modification to the HVAC
system or renovation to the pharmacy cleanrooms.
SEC HEPA Filter Leak Testing - Apparatus
A calibrated aerosol photometer that complies with the specification of IEST-RP-CC034.5 section 6.1.1
shall be used. The instrument shall be capable of measuring concentrations of up to 100 μg/L and have a
threshold sensitivity capable of measuring 0.0001 μg/L. The photometer should have a detection limit of
, at least0.1 x the designated leak and a volumetric flow rate of 1.0 CFM (28.3 L/min). The scanning probe
shall have a maximum open area of 1.7 in² (1100 mm²) and a minimum dimension of 0.50 inches (13
mm).
An aerosol generator of the Laskin nozzle type, thermal generator type or equivalent shall be used to
create an aerosol. The aerosol generator shall comply with the specifications of IEST-RP-CC034.5 section
6.1.4
IEST
Institute of Environmental Sciences and Technology
How do you estimate the HEPA filter medium to be tested?
For general purposes, subtracting 2" (5 cm) off of each outside filter dimension will yield a
representative effective filter area. This estimation is based on 3⁄4" (2 cm)for the filter frame and 1⁄4"
(0.5 cm) for the potting compound for a total of 1" (2.5cm) for each of the two dimensions four sides.
If the filter contains a center bar, it can generally be estimated at 1 ¼" (3 cm) in width.
Personnel who restock or clean and disinfect the sterile compounding area- ongoing training and
competency
Defined by facilities SOP
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 sleeves
Low Lint shoe covers
Low Lint cover for head and facial hair
Low Lint face mask
ANSWERS WITH RATIONALES (VERIFIED ANSWERS)
Designated Persons - ongoing training and competency
Training and Competency in compounding sterile principles - at least every 12 months unless
compounding
Garbing Competency - At least every 12 months unless compounding
Media Fill with Post GFT and Surface sampling -at least every 12 months unless compounding
What are requirements of a C-SEC
externally vented, be physically separated, have appropriate acph, must have a negative pressure
between negative 0.01 and 0.03 inches of water column relative to adjacent areas
Describe an HD sterile compounding setup
Iso Class 7 buffer room with an iso class 7 ante room, C-PEC (externally vented) BSC Class II OR A CACI, C-
SEC is externally vented, 30 ACPH, negative pressure 0.01 to 0.03.
Describe a C-SCA
Containment-Segregated Compounding Area - This is an unclassified space, with an externally vented
BSC Class II or a CACI, negative pressure room 0.01-0.030, 12 ACPH externally vented. BUD is for
category 1 drugs
How far does the sink in an HD ante room need to be away from the entrance to the HD buffer room?
1 meter
What are the requirements if an HD buffer room is entered through a Non-HD buffer room?
Line of Demarcation in the negative room for donning/doffing garb, there must be a method of
transporting HD drugs out of the HD buffer room, i.e. pass thrus.
CSTD
closed system drug transfer device
CSTD definition
A drug-transfer device that mechanically prohibits the transfer of environmental contaminants into the
system and the escape of HD or vapor concentrations outside the system.
What are the 3 engineering controls for HD CSP
Primary, Secondary, Supplemental
Unidirectional Airflow
An airflow moving in a single direction, in a robust and uniform manner, and at sufficient speed to
reproducibly sweep particles away from the critical processing or testing area
,ISO
International Organization for Standardization
As Built
condition where the cleanroom is complete with all services connected and functioning but with no
equipment, furniture, materials or personnel present
at-rest
condition of the cleanroom is complete with equipment installed and operating in a manner agreed
upon, but with no personnel present.
operational condition
agreed condition where the cleanroom is functioning with equipment operating and with specified
number of personnel present
How is particle size measured?
numbers of particles per cubic meter
LSAPC
Light Scattering Airborne Particle Counter
PAO
Polyalphaolefin
Visual Smoke Study
A test, used in ISO Class 7 and ISO Class 8 rooms that do not have unidirectional airflow, in which a
visible source of smoke, which is close to neutrally buoyant, issued to verify an absence of stagnant
airflow where particulates can accumulate. This test does not need to be performed under dynamic
operating conditions and is not appropriate for PECs (see Dynamic airflow smoke pattern test). This test
is done when an ISO Classified room has ceiling mounted air returns. It only needs to be done when the
room is first commissioned and again when any changes to the room configuration which may affect the
room's performance are made.
What apparatus is used for airflow testing in SEC?
A calibrated air multimeter with an accuracy of ± 3% of reading ± 7 CFM (± 12m3 /h), in conjunction
with;
A capture hood with properly sized shroud or a multi-point tube array with proper stand offs (typically
6" (15 cm) are used)
A calibrated thermal anemometer with an accuracy of ± 3 ft/min (± 0.015 m/s) or3% of the indicated
velocity, whichever is larger in conjunction with a rigid probe holder that will not distort airflow
,Non-ISO Classified Negative Pressure Turbulent Airflow Area Testing Procedure
ACPH requirements for containment segregated compounding areas and hazardous drug storage areas,
must be a minimum of 12 exhaust ACPH. Because these rooms/areas are not ISO classified airflow
measurements should be taken on the exhaust of negative pressure differential rooms.
Large Room Calculations for particle counts
M2/1000X27
Air sample conversion if less thant 1000 Liters
Raw Countx1000/sample size taken
What is actual vs standard
Standard is 70 and 14.7 psi at 0 humidity, actual is use actual temp and barometric pressure
ISO Classified Turbulent Airflow Area Reporting and Documentation
8 Minimum Documentations
Record all airflow measurements and their corresponding filter or diffuser locations or grid
identifications on a diagram
Calculate and report room volume
Calculate and report the average total room airflow volume
Calculate and report the total air changes per hour of the room (include LAFW and/or Non-ducted BSC
HEPA exhaust to room, if applicable)
Report any correction factors used or deviations from the primary method
Name of test (e.g., Room Airflow Analysis)
Report acceptance criteria
Provide a Pass or Fail statement based on the results of the test
SEC Airflow Testing Frequency
Airflow testing must be performed at least every six months or after any modification to the HVAC
system or renovation to the pharmacy cleanrooms.
SEC HEPA Filter Leak Testing - Apparatus
A calibrated aerosol photometer that complies with the specification of IEST-RP-CC034.5 section 6.1.1
shall be used. The instrument shall be capable of measuring concentrations of up to 100 μg/L and have a
threshold sensitivity capable of measuring 0.0001 μg/L. The photometer should have a detection limit of
, at least0.1 x the designated leak and a volumetric flow rate of 1.0 CFM (28.3 L/min). The scanning probe
shall have a maximum open area of 1.7 in² (1100 mm²) and a minimum dimension of 0.50 inches (13
mm).
An aerosol generator of the Laskin nozzle type, thermal generator type or equivalent shall be used to
create an aerosol. The aerosol generator shall comply with the specifications of IEST-RP-CC034.5 section
6.1.4
IEST
Institute of Environmental Sciences and Technology
How do you estimate the HEPA filter medium to be tested?
For general purposes, subtracting 2" (5 cm) off of each outside filter dimension will yield a
representative effective filter area. This estimation is based on 3⁄4" (2 cm)for the filter frame and 1⁄4"
(0.5 cm) for the potting compound for a total of 1" (2.5cm) for each of the two dimensions four sides.
If the filter contains a center bar, it can generally be estimated at 1 ¼" (3 cm) in width.
Personnel who restock or clean and disinfect the sterile compounding area- ongoing training and
competency
Defined by facilities SOP
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 sleeves
Low Lint shoe covers
Low Lint cover for head and facial hair
Low Lint face mask
