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CETA CERTIFICATION FOR STERILE COMPOUNDING FACILITIES EXAM
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CETA CERTIFICATION FOR STERILECOMPOUNDING FACILITIES EXAM
2024-2025
According to manufacturer instructions, at what temperature should test equipment
be brought to room temperature before being used? - ANSWER The temperature
ranges are 35°F to 105°F.
What temperature range is usual for applications in a clean room? - ANSWER
from 66° to 70°F.
What is the minimal ACPH that has been set forth for clean rooms used in ISO 7
sterile compounding? - ANSWER 30 ACPH
For an ISO 7 room, what is the lowest ACPH that the air supply passes through the
HEPA filters in the room? - ANSWER 15 ACPH
What is the minimum recommended ACPH from the ANTE Room's HEPA-
filtered air supply? - ANSWER 20 ACPH
What determines the positive pressure room exchange rate? - ANSWER Provide a
flow of air
What determines the negative pressure room exchange rate? - ANSWER Airflow
from the exhaust
, What is determined by measuring the exchange rate? - ANSWER Enough airflow
in both positive and negative pressure rooms to reduce and eliminate airborne
pollutants. As a result, only the supply HEPA-filtered air is used in the air change
measurements required by USP 797; the exhaust return air is not included.
What is the suggested method by the device manufacturer for monitoring air flow
volume using the capture hood? - ANSWER compensate for back pressure
What is compensation for back pressure? - ANSWER It is the culmination of all
forces, including air density and gravity, as well as the resistance brought on by
any drawn-through material, including HEPA filters.
When utilizing an anemometer to measure airflow in a sterile compounding
factory, what is the maximum recommended grid spacing? - ANSWER 1 foot2
Which kind of fog generators produce a fog that is denser than air and don't always
accurately depict the air patterns in real life? - ANSWER water-based, like liquid
nitrogen and carbon dioxide.
What does the industry guidance paper "Sterile Drug Products Produced by
Aseptic Processing - Current Good Manufacturing Practice" say about the FDA's
intentions regarding smoke studies? - 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 minimal pressure differential from adjacent spaces is required for clean
rooms used for nonhazardous compounding according to USP 797? - ANSWER
0.02" with w.c.
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