Master Parenteral Systems &
Biopharmaceutics: Brunetti's Lecture
5 Study Guide for 2025/2026 Exams -
Pass on Your First Attempt
CSP
- compounded sterile product
BUD
- beyond use date
- the hour and date after which a CSP must not be used and administration must not be started
,when to calculate BUD
- calculated from the time the compounding procedure was started
primary engineering controls
- devices that provide an "ISO Class 5" air quality environment for compounding
classified area
- an area that maintains an air quality classification based on an ISO designation
- also referred to as a secondary engineering control
unclassified area
- an area not required to meet any air cleanliness classification based on the ISO designations
ISO standards
- an air quality classification from the "international Organization for Standardization"
LAFWs (Laminar Airflow Workstations)
- more used primary engineering control device
, most common LAFWs
- Horizontal hoods
when are vertical hoods for LAFWs used
- whenever greater protection of compounding personnel is required, as when working with hazardous
materials
BCSs (biological safety cabinets)
- very similar to vertical air flow LAFWs but are also vented to the external environment
CAIs (Compounding Aseptic Isolators) and CACIs (Compounding Aseptic Containment Isolators)
- these types of primary engineering control devices are also simply called barrier isolators or glove
boxes
- involve restricted access into the direct compounding area through "glove ports"
- this eliminates the possibility of unfiltered external air from secondary engineering control space
entering the direct compounding area
CACIs are also...
- vented externally
Barrier isolators advantage
- provides maximum protection when working with hazardous materials
Biopharmaceutics: Brunetti's Lecture
5 Study Guide for 2025/2026 Exams -
Pass on Your First Attempt
CSP
- compounded sterile product
BUD
- beyond use date
- the hour and date after which a CSP must not be used and administration must not be started
,when to calculate BUD
- calculated from the time the compounding procedure was started
primary engineering controls
- devices that provide an "ISO Class 5" air quality environment for compounding
classified area
- an area that maintains an air quality classification based on an ISO designation
- also referred to as a secondary engineering control
unclassified area
- an area not required to meet any air cleanliness classification based on the ISO designations
ISO standards
- an air quality classification from the "international Organization for Standardization"
LAFWs (Laminar Airflow Workstations)
- more used primary engineering control device
, most common LAFWs
- Horizontal hoods
when are vertical hoods for LAFWs used
- whenever greater protection of compounding personnel is required, as when working with hazardous
materials
BCSs (biological safety cabinets)
- very similar to vertical air flow LAFWs but are also vented to the external environment
CAIs (Compounding Aseptic Isolators) and CACIs (Compounding Aseptic Containment Isolators)
- these types of primary engineering control devices are also simply called barrier isolators or glove
boxes
- involve restricted access into the direct compounding area through "glove ports"
- this eliminates the possibility of unfiltered external air from secondary engineering control space
entering the direct compounding area
CACIs are also...
- vented externally
Barrier isolators advantage
- provides maximum protection when working with hazardous materials
