,11/11/24, 11:23 AM CETa EXAM AND PRACTICE EXAM 2024-2025 ACTUAL EXAM 300 QUESTIONS AND CORRECT DETAILED ANSWERS WIT…
Terms in this set (316)
If a segregated it must have ISO Class 8 particle count non-viable
radiopharma processing particle count air quality
area is used to elute
radionuclides generators
A CSP assigned a BUD of 12 hours or less at
Category 1 CSP controlled room temperature or 24 hours or less
refrigerated.
A CSP assigned in a BUD of greater than 12 hours
Category 2 CSP room temperature or greater than 24 hours
refrigerated.
Administration begins within 4 hrs following the start
Immediate use CSP of the preparation. Must not involve more that 3
sterile products.
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
Glove Fingertip Sampling
days, record CFU, Determine if CFU action level is
exceeded by counting the total number of CFU from
both hands
, 11/11/24, 11:23 AM CETa EXAM AND PRACTICE EXAM 2024-2025 ACTUAL EXAM 300 QUESTIONS AND CORRECT DETAILED ANSWERS WIT…
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
Media Fill Testing perform gloved fingertip and thumb sampling on
Procedure 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.
After Garbing greater than 0 CFU
Action Level for Gloved After media-fill testing greater than 3 CFU
fingertip and thumb
sampling Action levels based on total CFU count from both
hands
Training and Competency in compounding sterile
principles - at least every 12 months
Garbing Competency - Category 1 and 2 at least
Compounder - ongoing
every 6 months, Category 3 every months
training and competency
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 compounding sterile
principles - at least every 12 months unless
Designated Persons - compounding
ongoing training and Garbing Competency - At least every 12 months
competency unless compounding
Media Fill with Post GFT and Surface sampling -at
least every 12 months unless compounding
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