DEFINITIONS / 2025.
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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