CETa UPDATED CORE EXAM MANUAL QUESTIONS AND
ANSWERS GRADED A+
✔✔What is Medium Risk? (USP 797) - ✔✔-Complex Process.
-Must be prepared in a cleanroom.
-Buffer Room with ante room.
✔✔What is High Risk? (USP 797) - ✔✔-Very Complex Processes
-Must be prepared in a clean room.
-Buffer Room with ante room.
✔✔Category 1 (USP 797) - ✔✔-simple processes
-shorter BUD
-may be prepared in unclassified compounding Area.
-BUD <12 hours at controlled room temp or 24 hours in fridge minimum.
✔✔Category 2 (USP797) - ✔✔- complex process
- longer BUD
-must be prepared in cleanroom
-buffer room with ante room
✔✔Category 3 (USP 797) - ✔✔-longer BUD's than allowed for category 2 compounded
sterile products
-must undergo sterility tests supplemented by endotoxin testing
-use of sterile garb
-use of sporicidal disinfectants, Frequent EM
-all compounding in facility must be category 3 if qualified
✔✔What is a CSP? - ✔✔-compounded sterile preparation
-for direct immediate administration to patient
-administration must begin within 4 hrs
✔✔where must Antineoplastic HD Drugs be stored? - ✔✔-stored separately from Non-
HD Drugs
-must be received and unpacked in a neutral or negative pressure room
-storage area must have a min of 12 exhaust air changes
-storage area must have min negative pressure of -0.01"WC
✔✔What is a closed system drug transfer device? (CSTD) - ✔✔- mechanically prohibits
the transfer of environmental contaminants into system and the escape of HD or Vapor
concentrations
-used in Bsc or CACI
✔✔What is a segregated radio pharmaceutical processing area (SPRA) - ✔✔-
designated unclassified space that contains a PEC
, -only suitable for preparation,dispensing and repacking
-If it meets ISO class 8, you can store non direct infusion radionuclide generators.
✔✔What Airflow requirements do ISO 7 Buffer Room Require?
*For Radio-pharmaceuticals - ✔✔-Most positive ++
-Min 30 ACH, at least 15 from HVAC
✔✔What Airflow requirements do ISO 8 Ante Room Require?
*For Radio-pharmaceuticals - ✔✔-Positive +
-Min 20 ACH, at least 15 from HVAC
✔✔What is an AECA? - ✔✔-a designated unclassified area suitable for allergen extract
preparation
-must be done in ISO class 5 suitable PEC
✔✔What is a Secondary engineering control? (SEC) - ✔✔-is a room which houses a
primary engineering control.
-often a cleanroom designed to control bioburden and total particulate levels.
✔✔What is a segregated compounding area? (SCA) - ✔✔-Non Hazardous drugs.
-Category 1 with shorter beyond use dates
✔✔What is a containment segregated compounding area (C-SCA) - ✔✔-Hazardous
Drugs
-Category 1 with shorter beyond use dates
-typically not HEPA Filtered
-typically no ISO Classification
✔✔what is a clean room consists of? (For SEC) - ✔✔-Category 2 CSP'S
-ISO 7 buffer room with ISO 5 PEC
-Mixed flow cleanroom with LVLFZ in class 7 buffer
ISO 7 or 8 anteroom
✔✔Remote Bank HEPA Filters are acceptable? - ✔✔- according to USP 797 no longer
acceptable
✔✔How do you calculate air changes? (ACHPH) - ✔✔-total room CFM/Room Volume
Ft3 X 60 to convert minutes to per hour.
✔✔what might you need to consider when accommodating a canopy connected BSC? -
✔✔-Ceiling height should be higher, 9 1/2 Ft Tall
-higher ceiling to accommodate balancing damper
ANSWERS GRADED A+
✔✔What is Medium Risk? (USP 797) - ✔✔-Complex Process.
-Must be prepared in a cleanroom.
-Buffer Room with ante room.
✔✔What is High Risk? (USP 797) - ✔✔-Very Complex Processes
-Must be prepared in a clean room.
-Buffer Room with ante room.
✔✔Category 1 (USP 797) - ✔✔-simple processes
-shorter BUD
-may be prepared in unclassified compounding Area.
-BUD <12 hours at controlled room temp or 24 hours in fridge minimum.
✔✔Category 2 (USP797) - ✔✔- complex process
- longer BUD
-must be prepared in cleanroom
-buffer room with ante room
✔✔Category 3 (USP 797) - ✔✔-longer BUD's than allowed for category 2 compounded
sterile products
-must undergo sterility tests supplemented by endotoxin testing
-use of sterile garb
-use of sporicidal disinfectants, Frequent EM
-all compounding in facility must be category 3 if qualified
✔✔What is a CSP? - ✔✔-compounded sterile preparation
-for direct immediate administration to patient
-administration must begin within 4 hrs
✔✔where must Antineoplastic HD Drugs be stored? - ✔✔-stored separately from Non-
HD Drugs
-must be received and unpacked in a neutral or negative pressure room
-storage area must have a min of 12 exhaust air changes
-storage area must have min negative pressure of -0.01"WC
✔✔What is a closed system drug transfer device? (CSTD) - ✔✔- mechanically prohibits
the transfer of environmental contaminants into system and the escape of HD or Vapor
concentrations
-used in Bsc or CACI
✔✔What is a segregated radio pharmaceutical processing area (SPRA) - ✔✔-
designated unclassified space that contains a PEC
, -only suitable for preparation,dispensing and repacking
-If it meets ISO class 8, you can store non direct infusion radionuclide generators.
✔✔What Airflow requirements do ISO 7 Buffer Room Require?
*For Radio-pharmaceuticals - ✔✔-Most positive ++
-Min 30 ACH, at least 15 from HVAC
✔✔What Airflow requirements do ISO 8 Ante Room Require?
*For Radio-pharmaceuticals - ✔✔-Positive +
-Min 20 ACH, at least 15 from HVAC
✔✔What is an AECA? - ✔✔-a designated unclassified area suitable for allergen extract
preparation
-must be done in ISO class 5 suitable PEC
✔✔What is a Secondary engineering control? (SEC) - ✔✔-is a room which houses a
primary engineering control.
-often a cleanroom designed to control bioburden and total particulate levels.
✔✔What is a segregated compounding area? (SCA) - ✔✔-Non Hazardous drugs.
-Category 1 with shorter beyond use dates
✔✔What is a containment segregated compounding area (C-SCA) - ✔✔-Hazardous
Drugs
-Category 1 with shorter beyond use dates
-typically not HEPA Filtered
-typically no ISO Classification
✔✔what is a clean room consists of? (For SEC) - ✔✔-Category 2 CSP'S
-ISO 7 buffer room with ISO 5 PEC
-Mixed flow cleanroom with LVLFZ in class 7 buffer
ISO 7 or 8 anteroom
✔✔Remote Bank HEPA Filters are acceptable? - ✔✔- according to USP 797 no longer
acceptable
✔✔How do you calculate air changes? (ACHPH) - ✔✔-total room CFM/Room Volume
Ft3 X 60 to convert minutes to per hour.
✔✔what might you need to consider when accommodating a canopy connected BSC? -
✔✔-Ceiling height should be higher, 9 1/2 Ft Tall
-higher ceiling to accommodate balancing damper
