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CETA EXAM PREP questions with verified answers
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CETA EXAM PREP questions with verified answers
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CETA EXAM PREPCompounding Aseptic Containment Isolator (CACI) - correct answer ✔✔-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) - correct answer ✔✔- 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) - correct answer ✔✔- Limited to Non-Sterile preparation.
-ISO 5 Horizontal/Vertical Unidirectional Air.
Vertical Laminar Flow Zone - correct answer ✔✔- Uses ceiling mounted HEPA's.
- Unidirectional airflow over stainless steel tables.
Biosafety Cabinet (BSC) - correct answer ✔✔-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 - correct answer ✔✔-Provides ISO 5.
-Automated Decon System.
-uses rapid transfer ports for material transfer.
Robotic Enclosure - correct answer ✔✔- Certification must include dynamic airflow smoke pattern
testing.
, USP Chapters Below _______ are enforceable while chapters above ______ are guidelines best practice -
correct answer ✔✔Answer: Below 1000, Above 1000.
Critical Area - correct answer ✔✔- Area within ISO class 5 PEC (Primary Engineering Control "BSC",
"Isolator").
What is unidirectional flow? - correct answer ✔✔- Utilizes flow control to eliminate particles from critical
work area.
What is non-directional flow? - correct answer ✔✔-Turbulent airflow uses dilution control to eliminate
particulate levels.
What is First Air? - correct answer ✔✔-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. - correct answer ✔✔-State of control.
-The Goal of certification is to prove state of control.
What is the beyond use date? (BUD) - correct answer ✔✔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) - correct answer ✔✔-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) - correct answer ✔✔-Complex Process.
-Must be prepared in a cleanroom.
-Buffer Room with ante room.
What is High Risk? (USP 797) - correct answer ✔✔-Very Complex Processes
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