PTCB CSPT EXAM
PTCB CSPT EXAM STUDY GUIDE 2025
GRADED A+
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).
,PTCB CSPT EXAM
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
, PTCB CSPT EXAM
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)
PTCB CSPT EXAM STUDY GUIDE 2025
GRADED A+
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).
,PTCB CSPT EXAM
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
, PTCB CSPT EXAM
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)
