CETA EXAM PREP QUESTION WITH COMPLETE
SOLUTION
Compounding Aseptic Containment Isolator (CACI)
-Used for Compounding HD Drugs.
-Class 1 CSP's may be placed in a SCA.
-Class 2 CSP's cleanroom with ISO 7 Buffer Room.
Compounding Aseptic Isolator (CAI)
- Used for Compounding Sterile Non-HD Drugs.
-Class 1 CSP's may be placed in a SCA.
-Class 2 CSP's cleanroom with ISO 7 Buffer Room.
Laminar Airflow Workbench (LAFW)
- Limited to Non-Sterile preparation.
-ISO 5 Horizontal/Vertical Unidirectional Air.
Vertical Laminar Flow Zone
- Uses ceiling mounted HEPA's.
- Unidirectional airflow over stainless steel tables.
Biosafety Cabinet (BSC)
-NIOSH Alert recommends No air recirculated for HD Preparation.
-Class II Type A2 Canopy Connected to exhaust system good for handling
vapors and gasses.
-Class II Type B2 used for highly volatile components.
Pharmaceutical Isolator
-Provides ISO 5.
-Automated Decon System.
-uses rapid transfer ports for material transfer.
Robotic Enclosure
- Certification must include dynamic airflow smoke pattern testing.
USP Chapters Below _______ are enforceable while chapters above
______ are guidelines best practice
Answer: Below 1000, Above 1000.
Critical Area
- Area within ISO class 5 PEC (Primary Engineering Control "BSC",
"Isolator").
What is unidirectional flow?
- Utilizes flow control to eliminate particles from critical work area.
What is non-directional flow?
, -Turbulent airflow uses dilution control to eliminate particulate levels.
What is First Air?
-the air exiting the HEPA filter in a unidirectional air stream that is
essentially particle free
A Regulated Facility is Required to maintain controlled environments
in a _____________________ at all times.
-State of control.
-The Goal of certification is to prove state of control.
What is the beyond use date? (BUD)
is the our and date after which a compounded preparation shall not be
used and is determined from the date/time when the preparation is
compounded.
What is Low Risk ? (USP 797)
-Simple Processes.
-prepared in ISO Class 5 or cleaner air.
-may be prepared in segregated compounding area BUD<12.
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
SOLUTION
Compounding Aseptic Containment Isolator (CACI)
-Used for Compounding HD Drugs.
-Class 1 CSP's may be placed in a SCA.
-Class 2 CSP's cleanroom with ISO 7 Buffer Room.
Compounding Aseptic Isolator (CAI)
- Used for Compounding Sterile Non-HD Drugs.
-Class 1 CSP's may be placed in a SCA.
-Class 2 CSP's cleanroom with ISO 7 Buffer Room.
Laminar Airflow Workbench (LAFW)
- Limited to Non-Sterile preparation.
-ISO 5 Horizontal/Vertical Unidirectional Air.
Vertical Laminar Flow Zone
- Uses ceiling mounted HEPA's.
- Unidirectional airflow over stainless steel tables.
Biosafety Cabinet (BSC)
-NIOSH Alert recommends No air recirculated for HD Preparation.
-Class II Type A2 Canopy Connected to exhaust system good for handling
vapors and gasses.
-Class II Type B2 used for highly volatile components.
Pharmaceutical Isolator
-Provides ISO 5.
-Automated Decon System.
-uses rapid transfer ports for material transfer.
Robotic Enclosure
- Certification must include dynamic airflow smoke pattern testing.
USP Chapters Below _______ are enforceable while chapters above
______ are guidelines best practice
Answer: Below 1000, Above 1000.
Critical Area
- Area within ISO class 5 PEC (Primary Engineering Control "BSC",
"Isolator").
What is unidirectional flow?
- Utilizes flow control to eliminate particles from critical work area.
What is non-directional flow?
, -Turbulent airflow uses dilution control to eliminate particulate levels.
What is First Air?
-the air exiting the HEPA filter in a unidirectional air stream that is
essentially particle free
A Regulated Facility is Required to maintain controlled environments
in a _____________________ at all times.
-State of control.
-The Goal of certification is to prove state of control.
What is the beyond use date? (BUD)
is the our and date after which a compounded preparation shall not be
used and is determined from the date/time when the preparation is
compounded.
What is Low Risk ? (USP 797)
-Simple Processes.
-prepared in ISO Class 5 or cleaner air.
-may be prepared in segregated compounding area BUD<12.
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
