PTCB CSPT EXAM 2023
Patient harmed by compounded sterile preparations - Answer- microbial contamination, excessive bacterial endotoxins, variability in strength of ingredients, chemical/physical contaminants, inappropriate quality of ingredients
non sterile compounding examples - Answer- products used orally, topically on skin or to fill gaps when not commercially available
aesptic - Answer- state of being free from microbial contamination
sterile compounded items - Answer- injections(iv, etc) ophthalmic drops, aqueous bronchial or nasal inhalations, baths for live organs, tissue implants, irrigation for wounds or cavities
Non hazardous hoods - Answer- Laminar airflow workbench (LAFW) compounding containment isolator (CAI)
Hazardous hoods - Answer- biological safety cabinet (BSC) compounding aseptic containment isolator (CACI)
Primary Engineering Control (PEC) - Answer- 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 - Answer- the ante area and buffer area
Buffer or Clean Room - Answer- ISO 7
Ante Room ISO class - Answer- ISO 8, unless provides access to negative pressure room then ISO 7
vertical hood - Answer- hazardous compounding-air flows vertically
Horizontal Hood - Answer- air flows horizontally across the work area from back to front
Direct Compounding Area (DCA) - Answer- - a critical area within the hood (ISO Class 5) where areas are exposed to filtered air; also known as "first air"
Negative Pressure room - Answer- Hazardous materials High-efficiency particulate air (HEPA) filters - Answer- remove microbes > 0.3 micrometers
Ante Room - Answer- washing, garbing, product decontamination
Buffer area air change per hour (APCH) - Answer- 30 exchanges per hour
ante room air change per hour (APCH) - Answer- ISO 8-20 per hour ISO 7- 30 per hour
Cleaning of compounding area - Answer- germicidal detergent & water for visible solids,
70% isopropyl alcohol
ISO Class 5 PEC cleaned - Answer- beginning of each shift, before each batch, every 30 minus when compounding, after spills, contamination
Cleaning of Counters and floors of specific sites - Answer- daily
Cleaning Walls, ceilings, storage shelving: - Answer- monthly
Suface sampling frequency - Answer- every 6 months or significant changes in procedure
Temperature of CSP areas - Answer- room temperature 20'C(68'F) or cooler
Airborne Particle Testing - Answer- every 6 months or device relocated or serviced
ISO class 5 Particle Limit for sterile compounding - Answer- 3,520 particles that are 0.5 micron or larger
ISO Class 7 Particle Limit for sterile compounding - Answer- 352,000 particles that are 0.5 micron or larger
ISO Class 8 Particle Limit for sterile compounding - Answer- 3,520,000 particles that are
0.5 micron or larger
ISO Class 5 Colony Forming Unit Action Level - Answer- 1 (>3)
ISO Class 7 Colony Forming Unit Action Level - Answer- 10-(>5)
ISO Class 8 Colony Forming Unit Action Level - Answer- 100 (>100)
Risk Level Classification - Answer- Low Risk, Medium Risk, High Risk, Immediate Use Risk
Low Risk Examples - Answer- -compounding piggybacks or hydration fluids in a ISO 5 laminar flow hood (LVP with KCl and or vitamins)
Patient harmed by compounded sterile preparations - Answer- microbial contamination, excessive bacterial endotoxins, variability in strength of ingredients, chemical/physical contaminants, inappropriate quality of ingredients
non sterile compounding examples - Answer- products used orally, topically on skin or to fill gaps when not commercially available
aesptic - Answer- state of being free from microbial contamination
sterile compounded items - Answer- injections(iv, etc) ophthalmic drops, aqueous bronchial or nasal inhalations, baths for live organs, tissue implants, irrigation for wounds or cavities
Non hazardous hoods - Answer- Laminar airflow workbench (LAFW) compounding containment isolator (CAI)
Hazardous hoods - Answer- biological safety cabinet (BSC) compounding aseptic containment isolator (CACI)
Primary Engineering Control (PEC) - Answer- 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 - Answer- the ante area and buffer area
Buffer or Clean Room - Answer- ISO 7
Ante Room ISO class - Answer- ISO 8, unless provides access to negative pressure room then ISO 7
vertical hood - Answer- hazardous compounding-air flows vertically
Horizontal Hood - Answer- air flows horizontally across the work area from back to front
Direct Compounding Area (DCA) - Answer- - a critical area within the hood (ISO Class 5) where areas are exposed to filtered air; also known as "first air"
Negative Pressure room - Answer- Hazardous materials High-efficiency particulate air (HEPA) filters - Answer- remove microbes > 0.3 micrometers
Ante Room - Answer- washing, garbing, product decontamination
Buffer area air change per hour (APCH) - Answer- 30 exchanges per hour
ante room air change per hour (APCH) - Answer- ISO 8-20 per hour ISO 7- 30 per hour
Cleaning of compounding area - Answer- germicidal detergent & water for visible solids,
70% isopropyl alcohol
ISO Class 5 PEC cleaned - Answer- beginning of each shift, before each batch, every 30 minus when compounding, after spills, contamination
Cleaning of Counters and floors of specific sites - Answer- daily
Cleaning Walls, ceilings, storage shelving: - Answer- monthly
Suface sampling frequency - Answer- every 6 months or significant changes in procedure
Temperature of CSP areas - Answer- room temperature 20'C(68'F) or cooler
Airborne Particle Testing - Answer- every 6 months or device relocated or serviced
ISO class 5 Particle Limit for sterile compounding - Answer- 3,520 particles that are 0.5 micron or larger
ISO Class 7 Particle Limit for sterile compounding - Answer- 352,000 particles that are 0.5 micron or larger
ISO Class 8 Particle Limit for sterile compounding - Answer- 3,520,000 particles that are
0.5 micron or larger
ISO Class 5 Colony Forming Unit Action Level - Answer- 1 (>3)
ISO Class 7 Colony Forming Unit Action Level - Answer- 10-(>5)
ISO Class 8 Colony Forming Unit Action Level - Answer- 100 (>100)
Risk Level Classification - Answer- Low Risk, Medium Risk, High Risk, Immediate Use Risk
Low Risk Examples - Answer- -compounding piggybacks or hydration fluids in a ISO 5 laminar flow hood (LVP with KCl and or vitamins)
