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Exam (elaborations)

CETA Exam Study Guide with Complete Solutions

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CETA Exam Study Guide with Complete Solutions If a segregated radiopharma processing area is used to elute radionuclides generators - Correct Answer️️ -it must have ISO Class 8 particle count non-viable particle count air quality Category 1 CSP - Correct Answer️️ -A CSP assigned a BUD ...

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  • September 25, 2024
  • 72
  • 2024/2025
  • Exam (elaborations)
  • Questions & answers
  • CETa
  • CETa
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EmillyCharlotte
TITLE: EMILLYCHARLOTTE 2024/2025 ACADEMIC PERIOD
OWNER: EMILLYCHARLOTTE
COPYRIGHT STATEMENT: ©2024 EMILLYCHARLOTTE. ALL RIGHTS
RESERVED
FIRST PUBLISHED: SEPTEMBER 2024

CETA Exam Study Guide with Complete
Solutions

If a segregated radiopharma processing area is used to elute radionuclides generators

- Correct Answer✔️✔️-it must have ISO Class 8 particle count non-viable particle count

air quality


Category 1 CSP - Correct Answer✔️✔️-A CSP assigned a BUD of 12 hours or less at

controlled room temperature or 24 hours or less refrigerated.

Category 2 CSP - Correct Answer✔️✔️-A CSP assigned in a BUD of greater than 12

hours room temperature or greater than 24 hours refrigerated.

Immediate use CSP - Correct Answer✔️✔️-Administration begins within 4 hrs following

the start of the preparation. Must not involve more that 3 sterile products.

Glove Fingertip Sampling - Correct 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 - Correct Answer✔️✔️-Simulate compounding activities if

sterile to sterile use soybean-casein digest media, if non sterile use commerically




1/72

,TITLE: EMILLYCHARLOTTE 2024/2025 ACADEMIC PERIOD
OWNER: EMILLYCHARLOTTE
COPYRIGHT STATEMENT: ©2024 EMILLYCHARLOTTE. ALL RIGHTS
RESERVED
FIRST PUBLISHED: SEPTEMBER 2024
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 - Correct 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 - Correct 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



2/72

,TITLE: EMILLYCHARLOTTE 2024/2025 ACADEMIC PERIOD
OWNER: EMILLYCHARLOTTE
COPYRIGHT STATEMENT: ©2024 EMILLYCHARLOTTE. ALL RIGHTS
RESERVED
FIRST PUBLISHED: SEPTEMBER 2024
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 - Correct 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 - Correct Answer✔️✔️-Defined by facilities SOP

Handwashing procedures - Correct 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


3/72

, TITLE: EMILLYCHARLOTTE 2024/2025 ACADEMIC PERIOD
OWNER: EMILLYCHARLOTTE
COPYRIGHT STATEMENT: ©2024 EMILLYCHARLOTTE. ALL RIGHTS
RESERVED
FIRST PUBLISHED: SEPTEMBER 2024



Allow hands to dry before donning sterile gloves

Minimum Garb requirements in category 2 and 3 - Correct 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 - Correct 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
4/72

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