Exam (elaborations)
CETA Exam with correct answers
- Course
- Institution
CETA Exam with correct answers
[Show more]
Content preview
CETA Exam with correct answersIf |a |segregated |radiopharma |processing |area |is |used |to |elute |radionuclides
|generators |- |ANSWERS✔✔ |it |must |have |ISO |Class |8 |particle |count |non-viable
|particle |count |air |quality
Category |1 |CSP |- |ANSWERS✔✔ |A |CSP |assigned |a |BUD |of |12 |hours |or |less |at
|controlled |room |temperature |or |24 |hours |or |less |refrigerated.
Category |2 |CSP |- |ANSWERS✔✔ |A |CSP |assigned |in |a |BUD |of |greater |than |12
|hours |room |temperature |or |greater |than |24 |hours |refrigerated.
Immediate |use |CSP |- |ANSWERS✔✔ |Administration |begins |within |4 |hrs
|following |the |start |of |the |preparation. |Must |not |involve |more |that |3 |sterile
|products.
Glove |Fingertip |Sampling |- |ANSWERS✔✔ |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 |- |ANSWERS✔✔ |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 |- |ANSWERS✔✔ |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 |- |ANSWERS✔✔ |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 |- |ANSWERS✔✔
|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 |- |ANSWERS✔✔ |Defined |by |facilities |SOP
Handwashing |procedures |- |ANSWERS✔✔ |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 |- |ANSWERS✔✔ |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 |- |ANSWERS✔✔ |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 |- |ANSWERS✔✔ |352,000 |particle |per |cubic |meter. |Limits
|measured |at |greater |than |0.5 |micrometers |under |dynamic |operating
|conditions
ISO |5 |Classification |- |ANSWERS✔✔ |3,520 |particle |count |per |cubic |meter.
|Limits |measured |at |greater |than |0.5 |micrometers |under |dynamic |conditions
ISO |8 |Classification |- |ANSWERS✔✔ |3,520,000 |particle |count |per |cubic |meter.
|Limits |measured |at |greater |than |0.5 |micrometers |under |dynamic |conditions
Design |Requirements |to |maintain |air |quality |<USP |797> |- |ANSWERS✔✔
|Anterooms |providing |access |to |positive-pressure |buffer |room |must |meet |at
|least |ISO |Class |8
Anterooms |providing |access |to |negative-pressure |buffer |rooms |must |meet |at
|least |an |ISO |Class |7. |
A |buffer |room |must |meet |at |least |ISO |Class |7 |air |quality. |Activities |in |the
|buffer |room |must |be |controlled |to |minimize |any |effect |on |air |quality |in |the
|are |where |CSP |are |prepared
Category |1, |Category |2, |and |Category |3 |CSPs |must |be |compounded |in |an |ISO
|Class |5 |or |better |PEC. |If |compounding |only |Category |1 |CSP, |the |PEC |may |be
|placed |in |a |Segregated |Compounding |Area
The benefits of buying summaries with Stuvia:
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
You can quickly pay through credit card or Stuvia-credit for the summaries. There is no membership needed.
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 Fordenken. Stuvia facilitates payment to the seller.
Will I be stuck with a subscription?
No, you only buy these notes for $17.99. You're not tied to anything after your purchase.
Can Stuvia be trusted?
4.6 stars on Google & Trustpilot (+1000 reviews)
83637 documents were sold in the last 30 days
Founded in 2010, the go-to place to buy study notes for 14 years now