Page 1 of 33 PTCB CSPT EXAM - Updated with Solution | All Covered PTCB CSPT EXAM.pdf
PTCB CSPT EXAM
microbial contamination, excessive bacterial endotoxins, variability in strength of
ingredients, chemical/physical contaminants, inappropriate quality of ingredients
Patient harmed by compounded sterile preparations
products used orally, topically on skin or to fill gaps when not commercially
available
non sterile compounding examples
state of being free from microbial contamination
aesptic
injections(iv, etc) ophthalmic drops, aqueous bronchial or nasal inhalations, baths
for live organs, tissue implants, irrigation for wounds or cavities
sterile compounded items
1 HTTPS://.COM/1048927/CSPT-EXAM-2-CSPT-EXAM-2-CSPT-INSTRUMENTS-CSPT-EXAM-2-FLASH-
CARDS/?NEW
PTCB CSPT EXAM PTCB CSPT EXAM.pdf PTCB CSPT EXAM.pdf
,Page 2 of 33 PTCB CSPT EXAM - Updated with Solution | All Covered PTCB CSPT EXAM.pdf
Laminar airflow workbench (LAFW) compounding containment isolator (CAI)
Non hazardous hoods
biological safety cabinet (BSC) compounding aseptic containment isolator (CACI)
Hazardous hoods
a device or room that provides an ISO Class 5 environment for the exposure of
critical sites when compounding CSPs. Such devices include, but may not be
limited to, laminar airflow workbenches (LAFWs), biological safety cabinets
(BSCs), compounding aseptic isolators (CAIs), and compounding aseptic
containment isolators (CACIs).
Primary Engineering Control (PEC)
the ante area and buffer area
secondary engineering controls
2 HTTPS://.COM/1048927/CSPT-EXAM-2-CSPT-EXAM-2-CSPT-INSTRUMENTS-CSPT-EXAM-2-FLASH-
CARDS/?NEW
PTCB CSPT EXAM PTCB CSPT EXAM.pdf PTCB CSPT EXAM.pdf
,Page 3 of 33 PTCB CSPT EXAM - Updated with Solution | All Covered PTCB CSPT EXAM.pdf
ISO 7
Buffer or Clean Room
ISO 8, unless provides access to negative pressure room then ISO 7
Ante Room ISO class
hazardous compounding-air flows vertically
vertical hood
air flows horizontally across the work area from back to front
Horizontal Hood
- a critical area within the hood (ISO Class 5) where areas are exposed to filtered
air; also known as "first air"
Direct Compounding Area (DCA)
3 HTTPS://.COM/1048927/CSPT-EXAM-2-CSPT-EXAM-2-CSPT-INSTRUMENTS-CSPT-EXAM-2-FLASH-
CARDS/?NEW
PTCB CSPT EXAM PTCB CSPT EXAM.pdf PTCB CSPT EXAM.pdf
, Page 4 of 33 PTCB CSPT EXAM - Updated with Solution | All Covered PTCB CSPT EXAM.pdf
Hazardous materials
Negative Pressure room
remove microbes > 0.3 micrometers
High-efficiency particulate air (HEPA) filters
washing, garbing, product decontamination
Ante Room
30 exchanges per hour
Buffer area air change per hour (APCH)
ISO 8-20 per hour ISO 7- 30 per hour
ante room air change per hour (APCH)
4 HTTPS://.COM/1048927/CSPT-EXAM-2-CSPT-EXAM-2-CSPT-INSTRUMENTS-CSPT-EXAM-2-FLASH-
CARDS/?NEW
PTCB CSPT EXAM PTCB CSPT EXAM.pdf PTCB CSPT EXAM.pdf
PTCB CSPT EXAM
microbial contamination, excessive bacterial endotoxins, variability in strength of
ingredients, chemical/physical contaminants, inappropriate quality of ingredients
Patient harmed by compounded sterile preparations
products used orally, topically on skin or to fill gaps when not commercially
available
non sterile compounding examples
state of being free from microbial contamination
aesptic
injections(iv, etc) ophthalmic drops, aqueous bronchial or nasal inhalations, baths
for live organs, tissue implants, irrigation for wounds or cavities
sterile compounded items
1 HTTPS://.COM/1048927/CSPT-EXAM-2-CSPT-EXAM-2-CSPT-INSTRUMENTS-CSPT-EXAM-2-FLASH-
CARDS/?NEW
PTCB CSPT EXAM PTCB CSPT EXAM.pdf PTCB CSPT EXAM.pdf
,Page 2 of 33 PTCB CSPT EXAM - Updated with Solution | All Covered PTCB CSPT EXAM.pdf
Laminar airflow workbench (LAFW) compounding containment isolator (CAI)
Non hazardous hoods
biological safety cabinet (BSC) compounding aseptic containment isolator (CACI)
Hazardous hoods
a device or room that provides an ISO Class 5 environment for the exposure of
critical sites when compounding CSPs. Such devices include, but may not be
limited to, laminar airflow workbenches (LAFWs), biological safety cabinets
(BSCs), compounding aseptic isolators (CAIs), and compounding aseptic
containment isolators (CACIs).
Primary Engineering Control (PEC)
the ante area and buffer area
secondary engineering controls
2 HTTPS://.COM/1048927/CSPT-EXAM-2-CSPT-EXAM-2-CSPT-INSTRUMENTS-CSPT-EXAM-2-FLASH-
CARDS/?NEW
PTCB CSPT EXAM PTCB CSPT EXAM.pdf PTCB CSPT EXAM.pdf
,Page 3 of 33 PTCB CSPT EXAM - Updated with Solution | All Covered PTCB CSPT EXAM.pdf
ISO 7
Buffer or Clean Room
ISO 8, unless provides access to negative pressure room then ISO 7
Ante Room ISO class
hazardous compounding-air flows vertically
vertical hood
air flows horizontally across the work area from back to front
Horizontal Hood
- a critical area within the hood (ISO Class 5) where areas are exposed to filtered
air; also known as "first air"
Direct Compounding Area (DCA)
3 HTTPS://.COM/1048927/CSPT-EXAM-2-CSPT-EXAM-2-CSPT-INSTRUMENTS-CSPT-EXAM-2-FLASH-
CARDS/?NEW
PTCB CSPT EXAM PTCB CSPT EXAM.pdf PTCB CSPT EXAM.pdf
, Page 4 of 33 PTCB CSPT EXAM - Updated with Solution | All Covered PTCB CSPT EXAM.pdf
Hazardous materials
Negative Pressure room
remove microbes > 0.3 micrometers
High-efficiency particulate air (HEPA) filters
washing, garbing, product decontamination
Ante Room
30 exchanges per hour
Buffer area air change per hour (APCH)
ISO 8-20 per hour ISO 7- 30 per hour
ante room air change per hour (APCH)
4 HTTPS://.COM/1048927/CSPT-EXAM-2-CSPT-EXAM-2-CSPT-INSTRUMENTS-CSPT-EXAM-2-FLASH-
CARDS/?NEW
PTCB CSPT EXAM PTCB CSPT EXAM.pdf PTCB CSPT EXAM.pdf
