Exam (elaborations)
CETA CAG008 STERILE COMPOUNDING FACILITIES EXAM
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CETA CAG008 STERILE COMPOUNDINGFACILITIES EXAM 2024-2025
The ANSWER Group, the CETA Board of Directors, is in charge of CETA's
activities and operations.
Facilities certification standards are outlined in the Certification Matrix -
ANSWER document.
Facilities for Preparing Sterile Medications: Sterile compounding facilities
The person in charge of overseeing CAG operations is the CAG Administrator.
HEPA Filter Integrity - Answer Method for Evaluating Filter Performance
To visualize airflow patterns in controlled situations, use the ANSWER test for the
Dynamic Airflow Smoke Pattern.
Main Engineering Controls: A Solution Systems essential for maintaining product
sterility
Assessing airborne particle levels using the ANSWER method of total airborne
particle sampling
CETA Application Guides: ANSWER Documents that offer clarification on
certification requirements
, USP Guidelines - ANSWER: Compiling regulations for pharmaceutical products
ANSWER Industry standards for facility certification: ISO, USP, NSF, and IEST
Report on Certification - ANSWER Document including test findings and facility
compliance information
Monitoring of the Environment - ANSWER Procedure for evaluating the
environmental state of a facility
ANSWER The designated pharmacist in charge of compounding operations is
known as the pharmacist-in-charge.
Robotic Cabinets - ANSWER closed-loop automated compounding systems
Appointed Individual - ANSWER The person is charge of adhering to USP
regulations
Reference Documents: ANSWER documents such as CETA CAG-003, IEST-RP-
CC002.4, and NEBB Procedural Standard that are used as references for
certification.
Referenced Literature - ANSWER references to additional reading in the
handbook, including NSF/ANSI 49 Biosafety Cabinetry, IEST-RP-CC034.4, and
CETA CAG-002.
Hood for Airflow Capture - Solution a hood used for inflow on a biological safety
cabinet that collects and measures the volume of airflow from a ventilation system.
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