PTCB CSPT EXAM Questions with complete solution
Grade A+.
1. Patient harmed by compounded sterile preparations: microbial contamina-
tion, excessive bacterial endotoxins, variability in strength of ingredients, chemi-
cal/physical contaminants, inappropriate quality of ingredients
2. non sterile compounding examples: products used orally, topically on skin or
to fill gaps when not commercially available
3. aesptic: state of being free from microbial contamination
4. sterile compounded items: injections(iv, etc) ophthalmic drops, aqueous
bronchial or nasal inhalations, baths for live organs, tissue implants, irrigation for
wounds or cavities
5. Non hazardous hoods: Laminar airflow workbench (LAFW) compounding con-
tainment isolator (CAI)
6. Hazardous hoods: biological safety cabinet (BSC) compounding aseptic con-
tainment isolator (CACI)
7. Primary Engineering Control (PEC): 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).
8. secondary engineering controls: the ante area and buffer area
9. Buffer or Clean Room: ISO 7
10. Ante Room ISO class: ISO 8, unless provides access to negative pressure
room then ISO 7
11. vertical hood: hazardous compounding-air flows vertically
12. Horizontal Hood: air flows horizontally across the work area from back to front
13. Direct Compounding Area (DCA): - a critical area within the hood (ISO Class
5) where areas are exposed to filtered air; also known as "first air"
14. Negative Pressure room: Hazardous materials
15. High-efficiency particulate air (HEPA) filters: remove microbes > 0.3 microm-
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, PTCB CSPT EXAM Questions with complete solution
Grade A+.
eters
16. Ante Room: washing, garbing, product decontamination
17. Buffer area air change per hour (APCH): 30 exchanges per hour
18. ante room air change per hour (APCH): ISO 8-20 per hour ISO 7- 30 per hour
19. Cleaning of compounding area: germicidal detergent & water for visible solids,
70% isopropyl alcohol
20. ISO Class 5 PEC cleaned: beginning of each shift, before each batch, every 30
minus when compounding, after spills, contamination
21. Cleaning of Counters and floors of specific sites: daily
22. Cleaning Walls, ceilings, storage shelving:: monthly
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Grade A+.
23. Suface sampling frequency: every 6 months or significant changes in proce-
dure
24. Temperature of CSP areas: room temperature 20'C(68'F) or cooler
25. Airborne Particle Testing: every 6 months or device relocated or serviced
26. ISO class 5 Particle Limit for sterile compounding: 3,520 particles that are
0.5 micron or larger
27. ISO Class 7 Particle Limit for sterile compounding: 352,000 particles that
are 0.5 micron or larger
28. ISO Class 8 Particle Limit for sterile compounding: 3,520,000 particles that
are 0.5 micron or larger
29. ISO Class 5 Colony Forming Unit Action Level: 1 (>3)
30. ISO Class 7 Colony Forming Unit Action Level: 10-(>5)
31. ISO Class 8 Colony Forming Unit Action Level: 100 (>100)
32. Risk Level Classification: Low Risk, Medium Risk, High Risk, Immediate Use
Risk
33. Low Risk Examples: -compounding piggybacks or hydration fluids in a ISO 5
laminar flow hood (LVP with KCl and or vitamins)
-Dual Chamber parenteral nutrition container with no more than 2 additives
34. Medium-risk examples: -TPN using manual or automated devices
-filling device reservoirs with more than 3 sterile drug products and evacuation of air
before dispensing
-transfer of volumes from multiple ampules or vials into one or more final sterile
containers
35. High risk examples: bulk drug containers, sterilization requirements, non-ster-
ile components
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Grade A+.
1. Patient harmed by compounded sterile preparations: microbial contamina-
tion, excessive bacterial endotoxins, variability in strength of ingredients, chemi-
cal/physical contaminants, inappropriate quality of ingredients
2. non sterile compounding examples: products used orally, topically on skin or
to fill gaps when not commercially available
3. aesptic: state of being free from microbial contamination
4. sterile compounded items: injections(iv, etc) ophthalmic drops, aqueous
bronchial or nasal inhalations, baths for live organs, tissue implants, irrigation for
wounds or cavities
5. Non hazardous hoods: Laminar airflow workbench (LAFW) compounding con-
tainment isolator (CAI)
6. Hazardous hoods: biological safety cabinet (BSC) compounding aseptic con-
tainment isolator (CACI)
7. Primary Engineering Control (PEC): 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).
8. secondary engineering controls: the ante area and buffer area
9. Buffer or Clean Room: ISO 7
10. Ante Room ISO class: ISO 8, unless provides access to negative pressure
room then ISO 7
11. vertical hood: hazardous compounding-air flows vertically
12. Horizontal Hood: air flows horizontally across the work area from back to front
13. Direct Compounding Area (DCA): - a critical area within the hood (ISO Class
5) where areas are exposed to filtered air; also known as "first air"
14. Negative Pressure room: Hazardous materials
15. High-efficiency particulate air (HEPA) filters: remove microbes > 0.3 microm-
mailto:https://www.stuvia.com/user/Wisdoms
, PTCB CSPT EXAM Questions with complete solution
Grade A+.
eters
16. Ante Room: washing, garbing, product decontamination
17. Buffer area air change per hour (APCH): 30 exchanges per hour
18. ante room air change per hour (APCH): ISO 8-20 per hour ISO 7- 30 per hour
19. Cleaning of compounding area: germicidal detergent & water for visible solids,
70% isopropyl alcohol
20. ISO Class 5 PEC cleaned: beginning of each shift, before each batch, every 30
minus when compounding, after spills, contamination
21. Cleaning of Counters and floors of specific sites: daily
22. Cleaning Walls, ceilings, storage shelving:: monthly
mailto:https://www.stuvia.com/user/Wisdoms
, PTCB CSPT EXAM Questions with complete solution
Grade A+.
23. Suface sampling frequency: every 6 months or significant changes in proce-
dure
24. Temperature of CSP areas: room temperature 20'C(68'F) or cooler
25. Airborne Particle Testing: every 6 months or device relocated or serviced
26. ISO class 5 Particle Limit for sterile compounding: 3,520 particles that are
0.5 micron or larger
27. ISO Class 7 Particle Limit for sterile compounding: 352,000 particles that
are 0.5 micron or larger
28. ISO Class 8 Particle Limit for sterile compounding: 3,520,000 particles that
are 0.5 micron or larger
29. ISO Class 5 Colony Forming Unit Action Level: 1 (>3)
30. ISO Class 7 Colony Forming Unit Action Level: 10-(>5)
31. ISO Class 8 Colony Forming Unit Action Level: 100 (>100)
32. Risk Level Classification: Low Risk, Medium Risk, High Risk, Immediate Use
Risk
33. Low Risk Examples: -compounding piggybacks or hydration fluids in a ISO 5
laminar flow hood (LVP with KCl and or vitamins)
-Dual Chamber parenteral nutrition container with no more than 2 additives
34. Medium-risk examples: -TPN using manual or automated devices
-filling device reservoirs with more than 3 sterile drug products and evacuation of air
before dispensing
-transfer of volumes from multiple ampules or vials into one or more final sterile
containers
35. High risk examples: bulk drug containers, sterilization requirements, non-ster-
ile components
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