CETA Certification for Sterile Compounding Facilities Exam Questions and Answers |100% Pass
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Course
2024/2025
Institution
2024/2025
CETA Certification for Sterile
Compounding Facilities Exam Questions
and Answers |100% Pass
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 ran...
What is back pressure compensation? - Answer✔✔-It is the sum total of forces such as gravity and air
density as well as resistance caused by any medium that is drawn through such as HEPA filters.
What is the maximum recommended grid spacing for sterile compounding facility airflow readings using
an anemometer? - Answer✔✔-1 ft2
What type of fog generators create a fog that is heavier than air and do not always provide for an
accurate representation of the actual air patterns? - Answer✔✔-Water-based such as C02 and liquid
nitrogen.
What are the FDA intentions for smoke studies stated in the guidance document for industry "Sterile
Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice"? - Answer✔✔-"In
situ air pattern analysis should be conducted at the critical area to demonstrate unidirectional airflow
and sweeping action over and away from the product under dynamic conditions".
What is the USP 797 minimum pressure differential requirement for clean rooms used for nonhazardous
compounding relative to adjacent spaces? - Answer✔✔-0.02" w.c. Positive
What does room segregation mean? - Answer✔✔-Room used to compound sterile preparations need to
be isolated from surrounding spaces.
What is the USP 797 minimum pressure differential requirement for clean rooms used for hazardous
compounding relative to adjacent spaces? - Answer✔✔-0.01"w.c. Negative
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