CETa EXAM AND PRACTICE EXAM ACTUAL EXAM 300 QUESTIONS AND CORRECT DETAILED ANSWERS WITH RATIONALES (VERIFIED ANSWERS)
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Course
CETa PRACTICE
Institution
CETa PRACTICE
If a segregated radiopharma processing
area is used to elute radionuclides generators
it must have ISO Class 8 particle count
non-viable particle count air quality
Category 1 CSP
A CSP assigned a BUD of 12 hours or
less at controlled room temperature or 24
hours or less refrigerated.
Catego...
CETa EXAM AND PRACTICE EXAM 2024-2025 ACTUAL EXAM 300 QUE
TIONS AND CORRECT DETAILED ANSWERS WITH RATIONALES (VER
FIED ANSWERS)
Study online at https://quizlet.com/_g19o2k
If a segregated radiopharma processing
it must have ISO Class 8 particle count
area is used to elute radionuclides gen-
non-viable particle count air quality
erators
A CSP assigned a BUD of 12 hours or
Category 1 CSP less at controlled room temperature or 24
hours or less refrigerated.
A CSP assigned in a BUD of greater than
Category 2 CSP 12 hours room temperature or greater
than 24 hours refrigerated.
Administration begins within 4 hrs follow-
Immediate use CSP ing the start of the preparation. Must not
involve more that 3 sterile products.
One plate per hand, TSA to support bac-
terial and fungal growth, label each de-
vice, do not spray hands with IPA, In-
Glove Fingertip Sampling cubate 30-35 for 48 H and 20-25 for 5
days, record CFU, Determine if CFU ac-
tion level is exceeded by counting the
total number of CFU from both hands
Simulate compounding activities if ster-
ile to sterile use soybean-casein digest
media, if non sterile use commerically
available nonsterile soybean-casein di-
gest powder to make a 3% non-sterile
solution. Preparer at least 1 container as
a positive control.
Media Fill Testing Procedure Once compounding simulations are
completed perform gloved fingertip and
thumb sampling on each hand and sur-
face 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.
, CETa EXAM AND PRACTICE EXAM 2024-2025 ACTUAL EXAM 300 QUE
TIONS AND CORRECT DETAILED ANSWERS WITH RATIONALES (VER
FIED ANSWERS)
Study online at https://quizlet.com/_g19o2k
Failure is indicated by visible turbidity or
other growth in one more containers on
or before 14 days.
After Garbing greater than 0 CFU
After media-fill testing greater than 3
Action Level for Gloved fingertip and CFU
thumb sampling
Action levels based on total CFU count
from both hands
Training and Competency in compound-
ing sterile principles - at least every 12
months
Garbing Competency - Category 1 and
Compounder - ongoing training and 2 at least every 6 months, Category 3
competency 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
Training and Competency in compound-
ing sterile principles - at least every 12
months unless compounding
Designated Persons - ongoing training Garbing Competency - At least every 12
and competency months unless compounding
Media Fill with Post GFT and Surface
sampling -at least every 12 months un-
less compounding
Personnel who restock or clean and dis-
infect the sterile compounding area- on- Defined by facilities SOP
going training and competency
, CETa EXAM AND PRACTICE EXAM 2024-2025 ACTUAL EXAM 300 QUE
TIONS AND CORRECT DETAILED ANSWERS WITH RATIONALES (VER
FIED ANSWERS)
Study online at https://quizlet.com/_g19o2k
Clean under fingernails under warm run-
ning 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 tow-
els.
Handwashing procedures
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
Low Lint garment with sleves
Low Lint shoe covers
Low Lint cover for head and facial hair
Minimum Garb requirements in category
2 and 3 Low Lint face mask
Sterile powder free gloves
If using a RABS disposable gloves
should be worn inside the RABS sleeves.
No exposed skin in the buffer room
(face/neck)
All lo-lint outer garb must be sterile, in-
cluding use of over gauntlet sleeves in
the RABS
, CETa EXAM AND PRACTICE EXAM 2024-2025 ACTUAL EXAM 300 QUE
TIONS AND CORRECT DETAILED ANSWERS WITH RATIONALES (VER
FIED ANSWERS)
Study online at https://quizlet.com/_g19o2k
Disposable garbing items must not be
reused, laundered garb must not be
reused without being laundered and
Additional garbing requirements for cat- re-sterilized with a validated cycle
egory 3
Facilities SOPs must describe proce-
dures for using goggles, respirators, and
other reusable equipment
352,000 particle per cubic meter. Limits
ISO 7 Classification measured at greater than 0.5 microme-
ters under dynamic operating conditions
3,520 particle count per cubic meter. Lim-
ISO 5 Classification its measured at greater than 0.5 microm-
eters under dynamic conditions
3,520,000 particle count per cubic meter.
ISO 8 Classification Limits measured at greater than 0.5 mi-
crometers under dynamic conditions
Anterooms providing access to posi-
tive-pressure buffer room must meet at
least ISO Class 8
Anterooms providing access to nega-
tive-pressure buffer rooms must meet at
least an ISO Class 7.
Design Requirements to maintain air A buffer room must meet at least ISO
quality <USP 797> 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
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