PTCB CSPT EXAM UPDATED
QUESTIONS AND CORRECT ANSWERS.
Patient harmed by compounded sterile preparations - ANS microbial contamination,
excessive bacterial endotoxins, variability in strength of ingredients, chemical/physical
contaminants, inappropriate quality of ingredients
non sterile compounding examples - ANS products used orally, topically on skin or to fill gaps
when not commercially available
aesptic - ANS state of being free from microbial contamination
sterile compounded items - ANS injections(iv, etc) ophthalmic drops, aqueous bronchial or
nasal inhalations, baths for live organs, tissue implants, irrigation for wounds or cavities
Non hazardous hoods - ANS Laminar airflow workbench (LAFW) compounding containment
isolator (CAI)
Hazardous hoods - ANS biological safety cabinet (BSC) compounding aseptic containment
isolator (CACI)
Primary Engineering Control (PEC) - ANS a device or room that provides an ISO Class 5
environment for the exposure of critical sites when compounding CSPs. Such devices include,
1 @COPYRIGHT 2025/2026 ALLRIGHTS RESERVED.
,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 - ANS the ante area and buffer area
Buffer or Clean Room - ANS ISO 7
Ante Room ISO class - ANS ISO 8, unless provides access to negative pressure room then ISO
7
vertical hood - ANS hazardous compounding-air flows vertically
Horizontal Hood - ANS air flows horizontally across the work area from back to front
Direct Compounding Area (DCA) - ANS - a critical area within the hood (ISO Class 5) where
areas are exposed to filtered air; also known as "first air"
Negative Pressure room - ANS Hazardous materials
High-efficiency particulate air (HEPA) filters - ANS remove microbes > 0.3 micrometers
Ante Room - ANS washing, garbing, product decontamination
Buffer area air change per hour (APCH) - ANS 30 exchanges per hour
2 @COPYRIGHT 2025/2026 ALLRIGHTS RESERVED.
, ante room air change per hour (APCH) - ANS ISO 8-20 per hour ISO 7- 30 per hour
Cleaning of compounding area - ANS germicidal detergent & water for visible solids, 70%
isopropyl alcohol
ISO Class 5 PEC cleaned - ANS beginning of each shift, before each batch, every 30 minus
when compounding, after spills, contamination
Cleaning of Counters and floors of specific sites - ANS daily
Cleaning Walls, ceilings, storage shelving: - ANS monthly
Suface sampling frequency - ANS every 6 months or significant changes in procedure
Temperature of CSP areas - ANS room temperature 20'C(68'F) or cooler
Airborne Particle Testing - ANS every 6 months or device relocated or serviced
ISO class 5 Particle Limit for sterile compounding - ANS 3,520 particles that are 0.5 micron or
larger
ISO Class 7 Particle Limit for sterile compounding - ANS 352,000 particles that are 0.5 micron
or larger
ISO Class 8 Particle Limit for sterile compounding - ANS 3,520,000 particles that are 0.5
micron or larger
3 @COPYRIGHT 2025/2026 ALLRIGHTS RESERVED.
QUESTIONS AND CORRECT ANSWERS.
Patient harmed by compounded sterile preparations - ANS microbial contamination,
excessive bacterial endotoxins, variability in strength of ingredients, chemical/physical
contaminants, inappropriate quality of ingredients
non sterile compounding examples - ANS products used orally, topically on skin or to fill gaps
when not commercially available
aesptic - ANS state of being free from microbial contamination
sterile compounded items - ANS injections(iv, etc) ophthalmic drops, aqueous bronchial or
nasal inhalations, baths for live organs, tissue implants, irrigation for wounds or cavities
Non hazardous hoods - ANS Laminar airflow workbench (LAFW) compounding containment
isolator (CAI)
Hazardous hoods - ANS biological safety cabinet (BSC) compounding aseptic containment
isolator (CACI)
Primary Engineering Control (PEC) - ANS a device or room that provides an ISO Class 5
environment for the exposure of critical sites when compounding CSPs. Such devices include,
1 @COPYRIGHT 2025/2026 ALLRIGHTS RESERVED.
,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 - ANS the ante area and buffer area
Buffer or Clean Room - ANS ISO 7
Ante Room ISO class - ANS ISO 8, unless provides access to negative pressure room then ISO
7
vertical hood - ANS hazardous compounding-air flows vertically
Horizontal Hood - ANS air flows horizontally across the work area from back to front
Direct Compounding Area (DCA) - ANS - a critical area within the hood (ISO Class 5) where
areas are exposed to filtered air; also known as "first air"
Negative Pressure room - ANS Hazardous materials
High-efficiency particulate air (HEPA) filters - ANS remove microbes > 0.3 micrometers
Ante Room - ANS washing, garbing, product decontamination
Buffer area air change per hour (APCH) - ANS 30 exchanges per hour
2 @COPYRIGHT 2025/2026 ALLRIGHTS RESERVED.
, ante room air change per hour (APCH) - ANS ISO 8-20 per hour ISO 7- 30 per hour
Cleaning of compounding area - ANS germicidal detergent & water for visible solids, 70%
isopropyl alcohol
ISO Class 5 PEC cleaned - ANS beginning of each shift, before each batch, every 30 minus
when compounding, after spills, contamination
Cleaning of Counters and floors of specific sites - ANS daily
Cleaning Walls, ceilings, storage shelving: - ANS monthly
Suface sampling frequency - ANS every 6 months or significant changes in procedure
Temperature of CSP areas - ANS room temperature 20'C(68'F) or cooler
Airborne Particle Testing - ANS every 6 months or device relocated or serviced
ISO class 5 Particle Limit for sterile compounding - ANS 3,520 particles that are 0.5 micron or
larger
ISO Class 7 Particle Limit for sterile compounding - ANS 352,000 particles that are 0.5 micron
or larger
ISO Class 8 Particle Limit for sterile compounding - ANS 3,520,000 particles that are 0.5
micron or larger
3 @COPYRIGHT 2025/2026 ALLRIGHTS RESERVED.
