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CETA EXAM; WITH 316 QUESTIONS AND VERIFIED ANSWERS
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CETA EXAM; WITH 316 QUESTIONS AND VERIFIEDANSWERS 2024-2025
When eluting radionuclides generators in a segregated radiopharma processing
area, the air quality must to meet ISO Class 8 particle count non-viable particle
count requirements.
Category 1 CSP - ANSWER A CSP with a BUD of 24 hours or less in a
refrigerator or 12 hours or less at controlled room temperature.
Category 2 CSP - ANSWER A CSP that has been refrigerated for more than 24
hours or kept at room temperature for more than 12 hours in a BUD.
CSP - ANSWER Administration for immediate use starts four hours after the
preparation phase begins. must only use three sterile goods at a time.
Glove Fingertip Sampling: ANSWER: Use one plate per hand, TSA to promote
fungal and bacterial growth, identify each device, avoid dousing hands in IPA,
incubate for 30 to 35 hours and 20 to 25 hours, record CFU, and count the total
number of CFU from both hands to see if the CFU action threshold is surpassed.
Media Fill Testing Procedure - Answer: If the conditions are sterile, use soybean-
casein digest media; if not, produce a 3% non-sterile solution using commercially
available non-sterile soybean-casein digest powder. As a positive control, prepare
at least one container.
After the compounding simulations are finished, sample each hand's gloved
fingertip and thumb, as well as the DCA surface inside the PEC. Gather samples
before you disinfect.
For a minimum of 7 days at each temperature, incubate 20–25 and 30-35.
,Visible turbidity or any other development in one or more containers on or before
the 14-day mark indicates failure.
Answer after garbing more than 0 CFU for gloved fingertip and thumb sampling:
Action Level
Following media-fill testing with more than three CFU
Levels of action determined on the combined CFU count of both hands
Compounder: continual training and competency; at least once every 12 months,
ANSWER: training and proficiency in compounding sterile principles
At least every six months, Category 1 and 2 and every month, Category 3 Garbing
Competency
At least every six months for Categories 1 and 2, and at least every three months
for Categories 3 and 4, media fill with post-GFT and surface sampling
At least once every 12 months, designated persons must complete continuing
ANSWER training and competency in compounding sterile principles, unless
compounding
Garbing Competency: Unless compounded, at least once every 12 months
Unless compounded, media fill with post-GFT and surface sampling should be
done at least once every 12 months.
Staff Members who replenish supplies or maintain the sterile compounding area:
continuous education and proficiency - defined by the establishment's standard
operating procedure
,Handwashing procedures: ANSWER Use a nail cleanser to clean under your
fingernails under warm flowing water.
Rinse hands and forearms for thirty seconds, up to the elbows.
Wipe hands and forearms totally dry with low-lint disposable towels, up to the
elbows.
massage dry skin with an alcohol-based hand massage.
Rub your hands together after applying product to one hand.
After letting hands dry, put on sterile gloves.
Category 2 and 3 minimum clothing requirements: ANSWER low-lint, sleeved
garment
Shoes with minimal lint
Low-lint hair covering for the face and head
Face mask with low lint
gloves free of sterile powder
Disposable gloves should be tucked into RABS sleeves when utilising one.
, Additional category 3 clothing requirements: ANSWER: No exposed skin (facial
or neck) in the buffer room
Including the usage of over gauntlet sleeves in the RABS, all lo-lint outer garments
must be sterile.
It is forbidden to reuse disposable gauze and laundered gauze without first
laundering and re-sterilizing it using a validated cycle.
SOPs for the facility must outline how to use respirators, goggles, and other
reusable equipment.
A ANSWER for the ISO 7 classification is 352,000 particles per cubic metre.
Limits under dynamic operating circumstances measured at more than 0.5
micrometres
3,520 particles per cubic metre is the answer for the ISO 5 classification system.
Limits under dynamic situations measured at more than 0.5 micrometres
The answer to the ISO 8 classification is 3,520,000 particles per cubic metre.
Limits under dynamic situations measured at more than 0.5 micrometres
<USP 797> - ANSWER Anterooms that provide access to a positive-pressure
buffer room must adhere to at least ISO Class 8 design requirements in order to
preserve air quality.
Anterooms that give access to buffer rooms under negative pressure have to be at
least ISO Class 7.
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