CETA Exam Complete Answers
1. 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. ---
2. Category 1 CSP
A CSP assigned a BUD of 12 hours or less at controlled room temperat...
1. 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.
---
2. Category 1 CSP
✅ A CSP assigned a BUD of 12 hours or less at controlled room temperature or 24 hours or less
refrigerated.
---
3. Category 2 CSP
✅ A CSP assigned in a BUD of greater than 12 hours at room temperature or greater than 24 hours
refrigerated.
---
4. Immediate use CSP
✅ Administration begins within 4 hrs following the start of the preparation. Must not involve more than
3 sterile products.
---
5. Glove Fingertip Sampling
✅ One plate per hand, TSA to support bacterial and fungal growth, label each device, do not spray
hands with IPA, incubate 30-35°C for 48 hours and 20-25°C for 5 days, record CFU, determine if CFU
action level is exceeded by counting the total number of CFU from both hands.
,---
6. Media Fill Testing Procedure
✅ Simulate compounding activities if sterile to sterile use soybean-casein digest media; if non-sterile
use commercially available non-sterile 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°C and 30-35°C for a minimum of 7 days at each
temperature. Failure is indicated by visible turbidity or other growth in one or more containers on or
before 14 days.
---
7. Action Level for Gloved Fingertip and Thumb Sampling
✅ After Garbing greater than 0 CFU. After media fill testing greater than 3 CFU. Action levels based on
total CFU count from both hands.
---
8. Compounder - Ongoing Training and Competency
✅ 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 month. Media fill with post
GFT and surface sampling - Category 1 and 2 at least every 6 months, Category 3 at least every 3
months.
---
9. Designated Persons - Ongoing Training and Competency
✅ 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.
,---
10. Personnel Who Restock or Clean and Disinfect the Sterile Compounding Area Ongoing Training and
Competency
✅ Defined by facility's SOP.
---
11. Handwashing Procedures
✅ Clean under fingernails under warm running water using nail cleaner. Wash hands and forearms up
to elbows for 30 seconds. 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.
---
12. Minimum Garb Requirements in Category 2 and 3
✅ Low lint garment with sleeves. 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.
---
13. Additional Garbing Requirements for Category 3
✅ 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 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.
---
14. ISO 7 Classification
, ✅ 352,000 particle count per cubic meter. Limits measured at greater than 0.5 micrometers under
dynamic operating conditions.
---
15. ISO 5 Classification
✅ 3,520 particle count per cubic meter. Limits measured at greater than 0.5 micrometers under
dynamic conditions.
---
16. ISO 8 Classification
✅ 3,520,000 particle count per cubic meter. Limits measured at greater than 0.5 micrometers under
dynamic conditions.
---
17. Design Requirements to Maintain Air Quality <USP 797>
✅ Anterooms providing access to positive-pressure buffer rooms 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 area where CSP are prepared.
---
18. 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.
---
19. What temperature and humidity level does the cleanroom suite need to be maintained?
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