PTCB CSPT Exam Questions And Answers
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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
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(BSCs), compounding aseptic isolators (CAIs), and compounding aseptic containment isolators
(CACIs).
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
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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)
ISO Class 7 Colony Forming Unit Action Level - Answer✔10-(>5)
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