PTCB CSPT EXAM (2025) ACTUAL EXAM comprehensive
questions and verified accurate solution (Detailed &
Elaborated) |get it 100% accurate!! 2025 TEST!!
beginning of each shift, before each batch, every 30
ISO Class 5 PEC cleaned
minus when compounding, after spills, contamination
Cleaning of Counters and daily
floors of specific sites
Cleaning Walls, ceilings, monthly
storage shelving:
Suface sampling frequency every 6 months or significant changes in procedure
Temperature of CSP areas room temperature 20'C(68'F) or cooler
Airborne Particle Testing every 6 months or device relocated or serviced
ISO class 5 Particle 3,520 particles that are 0.5 micron or larger
Limit for sterile
compounding
ISO Class 7 Particle Limit for 352,000 particles that are 0.5 micron or larger
sterile compounding
ISO Class 8 Particle Limit for 3,520,000 particles that are 0.5 micron or larger
sterile compounding
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, 4/11/25, 10:15 PM PTCB CSPT EXAM (2025) ACTUAL EXAM comprehensive questions and verified accurate solution (Detailed & Elaborated) |get it …
Patient harmed by microbial contamination, excessive bacterial endotoxins,
compounded sterile variability in strength of ingredients, chemical/physical
preparations contaminants, inappropriate quality of ingredients
non sterile compounding products used orally, topically on skin or to fill gaps when not
examples commercially available
aesptic state of being free from microbial contamination
injections(iv, etc) ophthalmic drops, aqueous bronchial or
sterile compounded items
nasal inhalations, baths for live organs, tissue implants,
irrigation for wounds or cavities
Non hazardous hoods Laminar airflow workbench (LAFW) compounding containment
isolator (CAI)
Hazardous hoods biological safety cabinet (BSC) compounding aseptic
containment isolator (CACI)
a device or room that provides an ISO Class 5 environment for
the exposure of
Primary Engineering Control critical sites when compounding CSPs. Such devices
(PEC) 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 the ante area and buffer area
controls
Buffer or Clean Room ISO 7
Ante Room ISO class ISO 8, unless provides access to negative pressure room then
ISO 7
vertical hood hazardous compounding-air flows vertically
Horizontal Hood air flows horizontally across the work area from back to front
- a critical area within the hood (ISO Class 5) where
Direct Compounding Area
(DCA) areas are exposed to filtered air; also known as "first
air"
Negative Pressure room Hazardous materials
High-efficiency particulate air remove microbes > 0.3 micrometers
(HEPA) filters
Ante Room washing, garbing, product decontamination
Buffer area air change per 30 exchanges per hour
hour (APCH)
ante room air change per ISO 8-20 per hour ISO 7- 30 per hour
hour (APCH)
Cleaning of compounding germicidal detergent & water for visible solids, 70% isopropyl
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