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