PTCB CSPT EXAM QUESTIONS AND COMPLETE
ANSWERS
Patient harmed by compounded sterile preparations CORRECT ANSWERS microbial contamination, excessive bacterial endotoxins, variability in strength of ingredients, chemical/physical contaminants, inappropriate quality of ingredients
non sterile compounding examples CORRECT ANSWERS products used orally, topically on skin or to fill gaps when not commercially available
aesptic CORRECT ANSWERS state of being free from microbial contamination
sterile compounded items CORRECT ANSWERS injections(iv, etc) ophthalmic drops, aqueous bronchial or nasal inhalations, baths for live organs, tissue implants, irrigation for wounds or cavities
Non hazardous hoods CORRECT ANSWERS Laminar airflow workbench (LAFW) compounding containment isolator (CAI )
Hazardous hoods CORRECT ANSWERS biological safety cabinet (BSC) compounding aseptic containment isolator (CACI)
Primary Engineering Control (PEC) CORRECT ANSWERS 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 CORRECT ANSWERS the ante area and buffer area
Buffer or Clean Room CORRECT ANSWERS ISO 7
Ante Room ISO class CORRECT ANSWERS ISO 8, unless provides access to negative pressure
room then ISO 7
vertical hood CORRECT ANSWERS hazardous compounding-air flows vertically
Horizontal Hood CORRECT ANSWERS air flows horizontally across the work area from back to front Direct Compounding Area (DCA) CORRECT ANSWERS - a critical area within the hood (ISO Class 5) where areas are exposed to filtered air; also known as "first air"
Negative Pressure room CORRECT ANSWERS Hazardous materials
High-efficiency particulate air (HEPA) filters CORRECT ANSWERS remove microbes > 0.3 micrometers
Ante Room CORRECT ANSWERS washing, garbing, product decontamination
Buffer area air change per hour (APCH) CORRECT ANSWERS 30 exchanges per hour
ante room air change per hour (APCH) CORRECT ANSWERS ISO 8-20 per hour ISO 7- 30 per
hour
Cleaning of compounding area CORRECT ANSWERS germicidal detergent & water for visible solids, 70% isopropyl alcohol
ISO Class 5 PEC cleaned CORRECT ANSWERS beginning of each shift, before each batch, every 30 minus when compounding, after spills, contamination
Cleaning of Counters and floors of specific sites CORRECT ANSWERS daily
Cleaning Walls, ceilings, storage shelving: CORRECT ANSWERS monthly
Suface sampling frequency CORRECT ANSWERS every 6 months or significant changes in procedure
Temperature of CSP areas CORRECT ANSWERS room temperature 20'C(68'F) or cooler
Airborne Particle Testing CORRECT ANSWERS every 6 months or device relocated or serviced
ISO class 5 Particle Limit for sterile compounding CORRECT ANSWERS 3,520 particles that are 0.5 micron or larger
ISO Class 7 Particle Limit for sterile compounding CORRECT ANSWERS 352,000 particles that are 0.5 micron or larger
ISO Class 8 Particle Limit for sterile compounding CORRECT ANSWERS 3,520,000 particles that are 0.5 micron or larger
ANSWERS
Patient harmed by compounded sterile preparations CORRECT ANSWERS microbial contamination, excessive bacterial endotoxins, variability in strength of ingredients, chemical/physical contaminants, inappropriate quality of ingredients
non sterile compounding examples CORRECT ANSWERS products used orally, topically on skin or to fill gaps when not commercially available
aesptic CORRECT ANSWERS state of being free from microbial contamination
sterile compounded items CORRECT ANSWERS injections(iv, etc) ophthalmic drops, aqueous bronchial or nasal inhalations, baths for live organs, tissue implants, irrigation for wounds or cavities
Non hazardous hoods CORRECT ANSWERS Laminar airflow workbench (LAFW) compounding containment isolator (CAI )
Hazardous hoods CORRECT ANSWERS biological safety cabinet (BSC) compounding aseptic containment isolator (CACI)
Primary Engineering Control (PEC) CORRECT ANSWERS 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 CORRECT ANSWERS the ante area and buffer area
Buffer or Clean Room CORRECT ANSWERS ISO 7
Ante Room ISO class CORRECT ANSWERS ISO 8, unless provides access to negative pressure
room then ISO 7
vertical hood CORRECT ANSWERS hazardous compounding-air flows vertically
Horizontal Hood CORRECT ANSWERS air flows horizontally across the work area from back to front Direct Compounding Area (DCA) CORRECT ANSWERS - a critical area within the hood (ISO Class 5) where areas are exposed to filtered air; also known as "first air"
Negative Pressure room CORRECT ANSWERS Hazardous materials
High-efficiency particulate air (HEPA) filters CORRECT ANSWERS remove microbes > 0.3 micrometers
Ante Room CORRECT ANSWERS washing, garbing, product decontamination
Buffer area air change per hour (APCH) CORRECT ANSWERS 30 exchanges per hour
ante room air change per hour (APCH) CORRECT ANSWERS ISO 8-20 per hour ISO 7- 30 per
hour
Cleaning of compounding area CORRECT ANSWERS germicidal detergent & water for visible solids, 70% isopropyl alcohol
ISO Class 5 PEC cleaned CORRECT ANSWERS beginning of each shift, before each batch, every 30 minus when compounding, after spills, contamination
Cleaning of Counters and floors of specific sites CORRECT ANSWERS daily
Cleaning Walls, ceilings, storage shelving: CORRECT ANSWERS monthly
Suface sampling frequency CORRECT ANSWERS every 6 months or significant changes in procedure
Temperature of CSP areas CORRECT ANSWERS room temperature 20'C(68'F) or cooler
Airborne Particle Testing CORRECT ANSWERS every 6 months or device relocated or serviced
ISO class 5 Particle Limit for sterile compounding CORRECT ANSWERS 3,520 particles that are 0.5 micron or larger
ISO Class 7 Particle Limit for sterile compounding CORRECT ANSWERS 352,000 particles that are 0.5 micron or larger
ISO Class 8 Particle Limit for sterile compounding CORRECT ANSWERS 3,520,000 particles that are 0.5 micron or larger
