Primary Engineering Controls and Laminar Airflow SYSTEMS, Exams of Nursing

Primary Engineering Controls and Laminar Airflow SYSTEMS

Typology: Exams

2025/2026

Available from 05/27/2026

Prof.KimberlyDavid
Prof.KimberlyDavid 🇺🇸

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Primary Engineering Controls and
Laminar Airflow Systems
PEC should be turned off when not in use to reduce wear and maintenance of
HEPA filter
False
Should always be operational
If turned off needs to runs for at least 30 minutes before compounding
Laminar Airflow Workbench
(LAFW)
1) Describe how air gets filtered
2) Is flow horizontal or vertical
3) Can be use for HD Compounding?
Laminar Airflow Workbench
(LAFW)
1) Room air -> filter -> HEPA filter -> work zone
2) Horizontal most common but can be either
3) No HD. No environmental or personal controls
Describe the zone of turbulence
Area behind any item (e.g., vial, IV bag, syringe) on the hood where sterile
airflow from the HEPA filter is interrupted; the zone or area is thereby
contaminated; sterile parenteral products should not be prepared within a
zone of turbulence
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Primary Engineering Controls and

Laminar Airflow Systems

PEC should be turned off when not in use to reduce wear and maintenance of HEPA filter False Should always be operational If turned off needs to runs for at least 30 minutes before compounding Laminar Airflow Workbench (LAFW)

  1. Describe how air gets filtered
  2. Is flow horizontal or vertical
  3. Can be use for HD Compounding? Laminar Airflow Workbench (LAFW)
  4. Room air -> filter -> HEPA filter -> work zone
  5. Horizontal most common but can be either
  6. No HD. No environmental or personal controls Describe the zone of turbulence Area behind any item (e.g., vial, IV bag, syringe) on the hood where sterile airflow from the HEPA filter is interrupted; the zone or area is thereby contaminated; sterile parenteral products should not be prepared within a zone of turbulence

Laminar Airflow Zone (LAFZ)

  1. Commonly also know as what
  2. Describe airflow
  3. Vertical or horizontal airflow
  4. Can be used for HD compounding? Laminar Airflow Zone (LAFZ)
  5. Open architecture cleanroom
  6. Air is filtered by ceiling mounted fan filters. Moves in downward motion then air cascades over sides of table and then into air returns
  7. Vertical
  8. NO, No environmental controls Laminar Airflow Zone (LAFZ)
  9. How is PEC zone created since there is not a cabinet
  10. Can this be used for category 2 compounding Laminar Airflow Zone (LAFZ)
  11. Containment curtain
  12. Yes if they are certified Biological Safety Cabinet (BSC)
  13. What type of compounding is typically done in this cabinet
  14. Vertical or horizontal airflow
  15. When is air HEPA filtered
  16. What are the different types of BSC

PEC: BSC Class II Type B How does air flow differ in this PEC PEC: BSC Class II Type B -70% is externally exhausted and 30% is recirculated -Can be used for larger quantities of volatile chemicals -Still must be externally vented PEC: BSC Class II Type B How does air flow differ in this PEC PEC: BSC Class II Type B -100% externally exhausted NO recirculated air -Contaminated plenums and ducts under negative pressure -HEPA filtered down-flow air and HEPA filtered exhausted air Restricted Access Barrier System (RABS)

  1. Define
  2. What ISO class and air flow is produced Restricted Access Barrier System (RABS)
  3. Enclosure with rigid walls, glove ports, and transfer doors
  4. ISO 5 unidirectional air Main types of RABS Compounding aseptic isolators (CAI)

Compounding aseptic containment isolators (CACI) Pharmacy robotic IV systems How does USP define an isolator Rigid wall enclosure providing full isolation from the surrounding area What are the 4 USP standards of a quality isolator

  1. High-integrity transfer ports for moving needed items in and out of isolator 2)Automated decontamination with sporicial agent in the isolator chamber 3)Positive pressure at least 0.05 inch water column 4)Manufacturer documentation that isolator Meets ISO 5 conditions during material transfer
  2. In what ISO class can an isolator be placed
  3. Can a sink be located in this room
  4. ISO class 8 or better because it is an enclosed system
  5. Yes is at least 1 meter from isolator
  6. Why are meeting the 4 USP standards for an isolator so important
  7. What if isolator does not meet the USP standards
  8. They can be used to prepare category 1 and 2 CSPs
  9. It is considered a RABS Why is it important to know recovery time of isolator -You need to know how long it will take your isolator to recover after an excursion -Ensure that internal procedures allow adequate recovery time after material transfer -This needs to be documented for reference T/F Isolator should be cleaned while closed False! Isolator MUST be opened during cleaning Describe the basic components of a RABS -Enclosure with rigid walls -Glove ports -Transfer doors

Isolator!!! If the isolator meets 4 specific USP requirements How do hazardous and non-hazardous PEC differ Containment is as important as maintaining ISO 5