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CETA Exam Flashcards With Complete Solutions Latest Update
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CETA Exam Flashcards With CompleteSolutions Latest Update
If a segregated radiopharma processing area is used to elute radionuclides generators -
ANSWER it must have ISO Class 8 particle count non-viable particle count air quality
Category 1 CSP - ANSWER A CSP assigned a BUD of 12 hours or less at controlled room
temperature or 24 hours or less refrigerated.
Category 2 CSP - ANSWER A CSP prepared in a BUD of more than 12 hours room
temperature or more than 24 hours refrigerated.
Immediate use CSP - ANSWER Administration begins within 4 hrs after the beginning of
the preparation. Cannot include more that 3 sterile products.
Glove Fingertip Sampling - 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 - ANSWER Aseptically simulate compounding activities if
sterile to sterile use soybean-casein digest media, if non sterile use commercially
available nonsterile soybean-casein digest powder to make a 3% non-sterile solution.
Prepare 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 - 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 - 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
Media Fill with Post GFT and Surface sampling - Category 1 and 2 at minimum every 6
months, Category 3 at minimum every 3 months
Designated Persons - ongoing training and competency - ANSWER Training and
Competency in compounding sterile principles - minimum frequency every 12 months
unless compounding
Garbing Competency - Minimum of every 12 months unless compounding
Media Fill with Post GFT and Surface sampling -at minimum of every 12 months unless
compounding
Personnel who restock or clean and disinfect the sterile compounding area- ongoing
training and competency - ANSWER Defined by facilities SOP
Handwashing procedures - ANSWER Clean under fingernails under warm running water
using nail cleaner
Wash hands and forearms up to elbows for 30 s.
,Dry all of hands and forearms up to elbows completely with low-lint disposable towels.
Apply 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 - 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.
More detailed garbing for category 3 - ANSWER No exposed skin in the buffer room
(face/neck)
All low-lint outer garb must be sterile, including use of over gauntlet sleeves in the RABS
Disposable garbing items must not be re-used, laundered garb must not be re-used
without being laundered and re-sterilised with a validated cycle
Facilities SOPs must address the use of goggles, respirators and other re-usable items
, ISO 7 Classification - ANSWER 352,000 particle per cubic meter. Limits measured at
greater than 0.5 micrometers under dynamic operating conditions
ISO 5 Classification - ANSWER 3,520 particle count per cubic meter. Limits measured at
greater than 0.5 micrometers under dynamic conditions
ISO 8 Classification - ANSWER 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> - ANSWER 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 area must be 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 shall 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 should be the temperature and humidity level of the cleanroom suite? -ANSWER
The temperature should be 20 degrees or less with a relative humidity at or below 60
percent in order to minimize the risk of microbial proliferation, as well as in
consideration for the comfort of compounding personnel attired in required garb.
How often does the temperature and humidity need to be monitored? - ANSWER The
temp and humidity need to be monitored each day that compounding is performed,
either manually or by a continuous recording device.
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