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Exam (elaborations)

PTCB CSPT EXAM QUESTIONS & CERTIFIED DEFINITIONS / 2025.

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PTCB CSPT EXAM QUESTIONS & CERTIFIED DEFINITIONS / 2025. Patient harmed by compounded sterile preparations, microbial contamination, excessive bacterial endotoxins, variability in strength of ingredients, chemical/physical contaminants, inappropriate quality of ingredients non sterile compounding examples products used orally, topically on skin or to fill gaps when not commercially available aesptic state of being free from microbial contamination sterile compounded items injections(iv, etc) ophthalmic drops, aqueous bronchial or 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) 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). secondary engineering controls the ante area and buffer area 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 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" Negative Pressure room Hazardous materials High-efficiency particulate air (HEPA) filters remove microbes > 0.3 micrometers Ante Room washing, garbing, product decontamination Buffer area air change per hour (APCH) 30 exchanges per hour

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Uploaded on
January 13, 2025
Number of pages
11
Written in
2024/2025
Type
Exam (elaborations)
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PTCB CSPT EXAM QUESTIONS & CERTIFIED
DEFINITIONS / 2025.

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Terms in this set (126)

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

sterile compounded items injections(iv, etc) ophthalmic drops, aqueous bronchial
or nasal inhalations, baths for live organs, tissue
implants, irrigation for wounds or cavities


Non hazardous hoods Laminar airflow workbench (LAFW) compounding containment
isolator (CAI)


biological safety cabinet (BSC) compounding aseptic containment
Hazardous hoods
isolator (CACI)

, Primary Engineering a device or room that provides an ISO Class 5 environment
Control (PEC) 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).




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



Direct Compounding Area - a critical area within the hood (ISO Class 5) where areas are
(DCA) 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
area alcohol

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