CETa EXAM AND PRACTICE EXAM ACTUAL EXAM 300
QUESTIONS AND CORRECT DETAILED ANSWER
If a segregated radiopharma processing area is used to elute radionuclides
generators - ANSWER: it must have ISO Class 8 particle count non-viable particle
count air quality
Category 1 CSP - ANSWER: A CSP assigned a BUD of 12 hours or less at controlled
room temperature or 24 hours or less refrigerated.
Category 2 CSP - ANSWER: A CSP assigned in a BUD of greater than 12 hours room
temperature or greater than 24 hours refrigerated.
Immediate use CSP - ANSWER: Administration begins within 4 hrs following the
start of the preparation. Must not involve more that 3 sterile products.
Glove Fingertip Sampling - ANSWER: One plate per hand, TSA to support bacterial
and fungal growth, label each device, do not spray hands with IPA, Incubate 30-35
for 48 H and 20-25 for 5 days, record CFU, Determine if CFU action level is
exceeded by counting the total number of CFU from both hands
Media Fill Testing Procedure - ANSWER: Simulate compounding activities if sterile
to sterile use soybean-casein digest media, if non sterile use commerically
available nonsterile soybean-casein digest powder to make a 3% non-sterile
solution. Preparer at least 1 container as a positive control.
Once compounding simulations are completed perform gloved fingertip and thumb
sampling on each hand and surface sample of DCA inside the PEC. Take samples
prior to disinfecting.
Incubate 20-25 and 30-35 for a minimum of 7 days at each temperature.
Failure is indicated by visible turbidity or other growth in one more containers on
or before 14 days.
Action Level for Gloved fingertip and thumb sampling - ANSWER: After Garbing
greater than 0 CFU
After media-fill testing greater than 3 CFU
Action levels based on total CFU count from both hands
Compounder - ongoing training and competency - ANSWER: Training and
Competency in compounding sterile principles - at least every 12 months
Garbing Competency - Category 1 and 2 at least every 6 months, Category 3 every
months
,Media Fill with Post GFT and Surface sampling - Category 1 and 2 at least every 6
months, Category 3 at least every 3 months
Designated Persons - ongoing training and competency - ANSWER: 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
Personnel who restock or clean and disinfect the sterile compounding area- ongoing
training and competency - ANSWER: Defined by facilities SOP
Handwashing procedures - ANSWER: 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 - ANSWER: 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 - ANSWER: 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 - ANSWER: 352,000 particle per cubic meter. Limits measured at
greater than 0.5 micrometers under dynamic operating conditions
ISO 5 Classification - ANSWER: 3,520 particle count per cubic meter. Limits measured
at greater than 0.5 micrometers under dynamic conditions
ISO 8 Classification - ANSWER: 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> - ANSWER: 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? - ANSWER: 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? - ANSWER: 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? - ANSWER: 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? - ANSWER: Designated Person
Where can a PEC be located? - ANSWER: 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> - ANSWER: 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? - ANSWER: No
Can tacky mats be placed within ISO classified areas? - ANSWER: 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? - ANSWER: 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? - ANSWER: They must
be in separate rooms unless those PECs are sufficiently effective that the room can
continuously maintain ISO 7
SCA - ANSWER: Segregated compounding area
Describe a SCA according to USP <797> - ANSWER: 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
QUESTIONS AND CORRECT DETAILED ANSWER
If a segregated radiopharma processing area is used to elute radionuclides
generators - ANSWER: it must have ISO Class 8 particle count non-viable particle
count air quality
Category 1 CSP - ANSWER: A CSP assigned a BUD of 12 hours or less at controlled
room temperature or 24 hours or less refrigerated.
Category 2 CSP - ANSWER: A CSP assigned in a BUD of greater than 12 hours room
temperature or greater than 24 hours refrigerated.
Immediate use CSP - ANSWER: Administration begins within 4 hrs following the
start of the preparation. Must not involve more that 3 sterile products.
Glove Fingertip Sampling - ANSWER: One plate per hand, TSA to support bacterial
and fungal growth, label each device, do not spray hands with IPA, Incubate 30-35
for 48 H and 20-25 for 5 days, record CFU, Determine if CFU action level is
exceeded by counting the total number of CFU from both hands
Media Fill Testing Procedure - ANSWER: Simulate compounding activities if sterile
to sterile use soybean-casein digest media, if non sterile use commerically
available nonsterile soybean-casein digest powder to make a 3% non-sterile
solution. Preparer at least 1 container as a positive control.
Once compounding simulations are completed perform gloved fingertip and thumb
sampling on each hand and surface sample of DCA inside the PEC. Take samples
prior to disinfecting.
Incubate 20-25 and 30-35 for a minimum of 7 days at each temperature.
Failure is indicated by visible turbidity or other growth in one more containers on
or before 14 days.
Action Level for Gloved fingertip and thumb sampling - ANSWER: After Garbing
greater than 0 CFU
After media-fill testing greater than 3 CFU
Action levels based on total CFU count from both hands
Compounder - ongoing training and competency - ANSWER: Training and
Competency in compounding sterile principles - at least every 12 months
Garbing Competency - Category 1 and 2 at least every 6 months, Category 3 every
months
,Media Fill with Post GFT and Surface sampling - Category 1 and 2 at least every 6
months, Category 3 at least every 3 months
Designated Persons - ongoing training and competency - ANSWER: 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
Personnel who restock or clean and disinfect the sterile compounding area- ongoing
training and competency - ANSWER: Defined by facilities SOP
Handwashing procedures - ANSWER: 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 - ANSWER: 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 - ANSWER: 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 - ANSWER: 352,000 particle per cubic meter. Limits measured at
greater than 0.5 micrometers under dynamic operating conditions
ISO 5 Classification - ANSWER: 3,520 particle count per cubic meter. Limits measured
at greater than 0.5 micrometers under dynamic conditions
ISO 8 Classification - ANSWER: 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> - ANSWER: 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? - ANSWER: 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? - ANSWER: 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? - ANSWER: 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? - ANSWER: Designated Person
Where can a PEC be located? - ANSWER: 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> - ANSWER: 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? - ANSWER: No
Can tacky mats be placed within ISO classified areas? - ANSWER: 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? - ANSWER: 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? - ANSWER: They must
be in separate rooms unless those PECs are sufficiently effective that the room can
continuously maintain ISO 7
SCA - ANSWER: Segregated compounding area
Describe a SCA according to USP <797> - ANSWER: 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
