PTCB CSPT EXAM with Multiple Choice Questions
and Verified Answers 100% | A+ Graded
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)
and Verified Answers 100% | A+ Graded
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)
