CETA Certification for Sterile Compounding Facilities Exam
With Complete Solutions Latest Update
What temperature should test equipment be normalized to room temperature prior to
use per manufacturers recommendations? - ANSWER Ranges are between 35°F and
105°F.
What is the typical temperature range for clean room applications? - ANSWER Between
66° and 70°F
What is the established minimum ACPH required for clean rooms employed in sterile
compounding ISO 7? - ANSWER 30 ACPH
What is the minimum ACPH from air supply through the room HEPA filters for an ISO 7
room? - ANSWER 15 ACPH
What is the minimum recommended ACPH from HEPA filtered air supply in the ANTE
Room? - ANSWER 20 ACPH
What dictates the exchange rate for the positive pressure rooms? - ANSWER Supply air
flow
What dictates the exchange rate for the negative pressure rooms? - ANSWER Exhaust
airflow
What does measuring the exchange rate determined? ANSWER Sufficient airflow to
dilute and remove airborne contaminants in both positive and negative pressure rooms.
Therefore the air change measurements under USP 797 only involves the supply HEPA
filtered air and not the exhaust return air.
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