CETA EXAM 2024 | ACTUAL QUESTIONS
AND ANSWERS
If a segregated radiopharma processing area is used to elute radionuclides generators -
it must have ISO Class 8 particle count non-viable particle count air quality
Category 1 CSP - A CSP assigned a BUD of 12 hours or less at controlled room
tempe...
CETA EXAM 2024 | ACTUAL QUESTIONS
AND ANSWERS
If a segregated radiopharma processing area is used to elute radionuclides generators -
it must have ISO Class 8 particle count non-viable particle count air quality
Category 1 CSP - A CSP assigned a BUD of 12 hours or less at controlled room
temperature or 24 hours or less refrigerated.
Category 2 CSP - A CSP assigned in a BUD of greater than 12 hours room
temperature or greater than 24 hours refrigerated.
Immediate use CSP - Administration begins within 4 hrs following the start of the
preparation. Must not involve more that 3 sterile products.
Glove Fingertip Sampling - 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 - 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 - 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 - 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 - 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 - 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 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
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