©Themoon EXAM SOLUTIONS
19/11/2024 12:33PM
CETA Certification for Sterile Compounding
Facilities Solutions
What temperature should test equipment be normalized to room temperature prior to use per
manufacturers recommendations? - Answers✓✓Ranges are between 35°F and 105°F.
What is the typical temperature range for clean room applications? - Answers✓✓Between 66°
and 70°F
What is the established minimum ACPH required for clean rooms employed in sterile
compounding ISO 7? - Answers✓✓30 ACPH
What is the minimum ACPH from air supply through the room HEPA filters for an ISO 7
room? - Answers✓✓15 ACPH
What is the recommended minimum ACPH from HEPA filtered air supply in the ANTE Room?
- Answers✓✓20 ACPH
What establishes the exchange rate for positive pressure rooms? - Answers✓✓Supply air flow
What establishes the exchange rate for negative pressure rooms? - Answers✓✓Exhaust airflow
What does measuring the exchange rate determined? - Answers✓✓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.
, ©Themoon EXAM SOLUTIONS
19/11/2024 12:33PM
What should be used when measuring air flow volume with the capture hood as recommended
by the device manufacturer? - Answers✓✓Back pressure compensation
What is back pressure compensation? - Answers✓✓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? - Answers✓✓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? - Answers✓✓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"? - Answers✓✓"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? - Answers✓✓0.02" w.c. Positive
What does room segregation mean? - Answers✓✓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? - Answers✓✓0.01"w.c. Negative
19/11/2024 12:33PM
CETA Certification for Sterile Compounding
Facilities Solutions
What temperature should test equipment be normalized to room temperature prior to use per
manufacturers recommendations? - Answers✓✓Ranges are between 35°F and 105°F.
What is the typical temperature range for clean room applications? - Answers✓✓Between 66°
and 70°F
What is the established minimum ACPH required for clean rooms employed in sterile
compounding ISO 7? - Answers✓✓30 ACPH
What is the minimum ACPH from air supply through the room HEPA filters for an ISO 7
room? - Answers✓✓15 ACPH
What is the recommended minimum ACPH from HEPA filtered air supply in the ANTE Room?
- Answers✓✓20 ACPH
What establishes the exchange rate for positive pressure rooms? - Answers✓✓Supply air flow
What establishes the exchange rate for negative pressure rooms? - Answers✓✓Exhaust airflow
What does measuring the exchange rate determined? - Answers✓✓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.
, ©Themoon EXAM SOLUTIONS
19/11/2024 12:33PM
What should be used when measuring air flow volume with the capture hood as recommended
by the device manufacturer? - Answers✓✓Back pressure compensation
What is back pressure compensation? - Answers✓✓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? - Answers✓✓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? - Answers✓✓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"? - Answers✓✓"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? - Answers✓✓0.02" w.c. Positive
What does room segregation mean? - Answers✓✓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? - Answers✓✓0.01"w.c. Negative
