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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
,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)
aesptic - ANSWER-state of being free from
microbial contamination
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 (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