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CETA EXAM 2024/2025 WITH 100% ACCURATE SOLUTIONS
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CETA EXAM 2024/2025 WITH 100% ACCURATE SOLUTIONS
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CETA EXAM 2024/2025 WITH 100% ACCURATE SOLUTIONSIf a segregated radiopharma processing area is used to elute
radionuclides generators - Precise Answer ✔✔it must have ISO Class 8
particle count non-viable particle count air quality
Category 1 CSP - Precise Answer ✔✔A CSP assigned a BUD of 12
hours or less at controlled room temperature or 24 hours or less
refrigerated.
Category 2 CSP - Precise Answer ✔✔A CSP assigned in a BUD of
greater than 12 hours room temperature or greater than 24 hours
refrigerated.
Immediate use CSP - Precise Answer ✔✔Administration begins within
4 hrs following the start of the preparation. Must not involve more that 3
sterile products.
Glove Fingertip Sampling - Precise 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 - Precise 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 - Precise 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 - Precise 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 - Precise 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 - Precise Answer ✔✔Defined by
facilities SOP
Handwashing procedures - Precise 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 - Precise 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 - Precise 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
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