1|Page
CETA EXAM || QUESTIONS AND 100% CORRECT
ANSWERS ALREADY GRADED A+ LATEST AND
COMPLETE VERSION WITH VERIFIED
SOLUTIONS || GUARANTEED PASS!!
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.
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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
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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
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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
CETA EXAM || QUESTIONS AND 100% CORRECT
ANSWERS ALREADY GRADED A+ LATEST AND
COMPLETE VERSION WITH VERIFIED
SOLUTIONS || GUARANTEED PASS!!
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.
,2|Page
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
,3|Page
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
, 4|Page
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
