100% satisfaction guarantee Immediately available after payment Both online and in PDF No strings attached
logo-home
CETA Exam Study Guide with Complete Solutions $12.49   Add to cart

Exam (elaborations)

CETA Exam Study Guide with Complete Solutions

 6 views  0 purchase
  • Course
  • CETa
  • Institution
  • CETa

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 ...

[Show more]

Preview 4 out of 72  pages

  • September 25, 2024
  • 72
  • 2024/2025
  • Exam (elaborations)
  • Questions & answers
  • CETa
  • CETa
avatar-seller
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

The benefits of buying summaries with Stuvia:

Guaranteed quality through customer reviews

Guaranteed quality through customer reviews

Stuvia customers have reviewed more than 700,000 summaries. This how you know that you are buying the best documents.

Quick and easy check-out

Quick and easy check-out

You can quickly pay through credit card or Stuvia-credit for the summaries. There is no membership needed.

Focus on what matters

Focus on what matters

Your fellow students write the study notes themselves, which is why the documents are always reliable and up-to-date. This ensures you quickly get to the core!

Frequently asked questions

What do I get when I buy this document?

You get a PDF, available immediately after your purchase. The purchased document is accessible anytime, anywhere and indefinitely through your profile.

Satisfaction guarantee: how does it work?

Our satisfaction guarantee ensures that you always find a study document that suits you well. You fill out a form, and our customer service team takes care of the rest.

Who am I buying these notes from?

Stuvia is a marketplace, so you are not buying this document from us, but from seller EmillyCharlotte. Stuvia facilitates payment to the seller.

Will I be stuck with a subscription?

No, you only buy these notes for $12.49. You're not tied to anything after your purchase.

Can Stuvia be trusted?

4.6 stars on Google & Trustpilot (+1000 reviews)

75323 documents were sold in the last 30 days

Founded in 2010, the go-to place to buy study notes for 14 years now

Start selling
$12.49
  • (0)
  Add to cart