CETA Exam UNIT 1: Questions and Already passed Answers 2024
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CETa
CETA Exam UNIT 1: Questions and Already passed Answers 2024
If a segregated radiopharma processing area is used to elute radionuclides generators - ANS it must have ISO Class 8 particle count non-viable particle count air quality
Category 1 CSP - ANS A CSP assigned a BUD of 12 hours or le...
,If a segregated radiopharma processing area is used to elute radionuclides generators -
ANS it must have ISO Class 8 particle count non-viable particle count air quality
Category 1 CSP - ANS A CSP assigned a BUD of 12 hours or less at controlled room
temperature or 24 hours or less refrigerated.
Category 2 CSP - ANS A CSP assigned in a BUD of greater than 12 hours room
temperature or greater than 24 hours refrigerated.
Immediate use CSP - ANS Administration begins within 4 hrs following the start of the
preparation. Must not involve more that 3 sterile products.
M
Glove Fingertip Sampling - ANS 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
AO
Media Fill Testing Procedure - ANS 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
N
to disinfecting.
Incubate 20-25 and 30-35 for a minimum of 7 days at each temperature.
JP
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 - ANS 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 - ANS 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 - ANS 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
M
Personnel who restock or clean and disinfect the sterile compounding area- ongoing
training and competency - ANS Defined by facilities SOP
Handwashing procedures - ANS Clean under fingernails under warm running water
AO
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
N
Apply product to one hand and rub hands together
Allow hands to dry before donning sterile gloves
JP
Minimum Garb requirements in category 2 and 3 - ANS 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 - ANS 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
M
ISO 7 Classification - ANS 352,000 particle per cubic meter. Limits measured at
greater than 0.5 micrometers under dynamic operating conditions
ISO 5 Classification - ANS 3,520 particle count per cubic meter. Limits measured at
greater than 0.5 micrometers under dynamic conditions
AO
ISO 8 Classification - ANS 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> - ANS 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
N
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
JP
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
What temperature and humidity level does the cleanroom suite need to be maintained?
- ANS The cleanroom suite should be maintained at a temperature of 20 degrees or
cooler and a relative humidity of 60% or below to minimize the risk of microbial
proliferation and provide comfortable conditions for compounding personnel attired in
required garb.
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