PTCB CSPT EXAM QUESTIONS AND ANSWERS
Patient harmed by compounded sterile preparations
microbial contamination, excessive bacterial endotoxins, variability in strength of ingredients,
chemical/physical contaminants, inappropriate quality of ingredients
non sterile compounding examples
products used orally, topically on skin or to fill gaps when not commercially available
aesptic
state of being free from microbial contamination
sterile compounded items
injections(iv, etc) ophthalmic drops, aqueous bronchial or nasal inhalations, baths for live organs,
tissue implants, irrigation for wounds or cavities
Non hazardous hoods
Laminar airflow workbench (LAFW) compounding containment isolator (CAI)
Hazardous hoods
biological safety cabinet (BSC) compounding aseptic containment isolator (CACI)
Primary Engineering Control (PEC)
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).
secondary engineering controls
the ante area and buffer area
Buffer or Clean Room
ISO 7
Ante Room ISO class
ISO 8, unless provides access to negative pressure room then ISO 7
vertical hood
hazardous compounding-air flows vertically
Horizontal Hood
air flows horizontally across the work area from back to front
Direct Compounding Area (DCA)
, - a critical area within the hood (ISO Class 5) where areas are exposed to filtered air; also known as
"first air"
Negative Pressure room
Hazardous materials
High-efficiency particulate air (HEPA) filters
remove microbes > 0.3 micrometers
Ante Room
washing, garbing, product decontamination
Buffer area air change per hour (APCH)
30 exchanges per hour
ante room air change per hour (APCH)
ISO 8-20 per hour ISO 7- 30 per hour
Cleaning of compounding area
germicidal detergent & water for visible solids, 70% isopropyl alcohol
ISO Class 5 PEC cleaned
beginning of each shift, before each batch, every 30 minus when compounding, after spills,
contamination
Cleaning of Counters and floors of specific sites
daily
Cleaning Walls, ceilings, storage shelving:
monthly
Suface sampling frequency
every 6 months or significant changes in procedure
Temperature of CSP areas
room temperature 20'C(68'F) or cooler
Airborne Particle Testing
every 6 months or device relocated or serviced
ISO class 5 Particle Limit for sterile compounding
3,520 particles that are 0.5 micron or larger
Patient harmed by compounded sterile preparations
microbial contamination, excessive bacterial endotoxins, variability in strength of ingredients,
chemical/physical contaminants, inappropriate quality of ingredients
non sterile compounding examples
products used orally, topically on skin or to fill gaps when not commercially available
aesptic
state of being free from microbial contamination
sterile compounded items
injections(iv, etc) ophthalmic drops, aqueous bronchial or nasal inhalations, baths for live organs,
tissue implants, irrigation for wounds or cavities
Non hazardous hoods
Laminar airflow workbench (LAFW) compounding containment isolator (CAI)
Hazardous hoods
biological safety cabinet (BSC) compounding aseptic containment isolator (CACI)
Primary Engineering Control (PEC)
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).
secondary engineering controls
the ante area and buffer area
Buffer or Clean Room
ISO 7
Ante Room ISO class
ISO 8, unless provides access to negative pressure room then ISO 7
vertical hood
hazardous compounding-air flows vertically
Horizontal Hood
air flows horizontally across the work area from back to front
Direct Compounding Area (DCA)
, - a critical area within the hood (ISO Class 5) where areas are exposed to filtered air; also known as
"first air"
Negative Pressure room
Hazardous materials
High-efficiency particulate air (HEPA) filters
remove microbes > 0.3 micrometers
Ante Room
washing, garbing, product decontamination
Buffer area air change per hour (APCH)
30 exchanges per hour
ante room air change per hour (APCH)
ISO 8-20 per hour ISO 7- 30 per hour
Cleaning of compounding area
germicidal detergent & water for visible solids, 70% isopropyl alcohol
ISO Class 5 PEC cleaned
beginning of each shift, before each batch, every 30 minus when compounding, after spills,
contamination
Cleaning of Counters and floors of specific sites
daily
Cleaning Walls, ceilings, storage shelving:
monthly
Suface sampling frequency
every 6 months or significant changes in procedure
Temperature of CSP areas
room temperature 20'C(68'F) or cooler
Airborne Particle Testing
every 6 months or device relocated or serviced
ISO class 5 Particle Limit for sterile compounding
3,520 particles that are 0.5 micron or larger
