WITH EXPLANATIONS (VERIFIED ANSWERS) A NEW UPDATED
VERSION LATEST| GUARANTEED A+
1) Patient harmed by compounded microbial contamination, excessive
sterile preparations bacterial endotoxins, variability in
strength of ingredients,
chemical/physical contaminants,
inappropriate quality of ingredients
2) non sterile compounding products used orally, topically on skin
examples or to fill gaps when not commercially
available
3) aesptic state of being free from microbial
contamination
4) sterile compounded items injections(iv, etc) ophthalmic drops,
aqueous bronchial or nasal
inhalations, baths for live organs,
tissue implants, irrigation for wounds
or cavities
,5) Non hazardous hoods Laminar airflow workbench (LAFW)
compounding containment isolator
(CAI)
6) Hazardous hoods biological safety cabinet (BSC)
compounding aseptic containment
isolator (CACI)
7) Primary Engineering Control a device or room that provides an ISO
(PEC) 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).
8) secondary engineering controls the ante area and buffer area
9) Buffer or Clean Room ISO 7
10) Ante Room ISO class ISO 8, unless provides access to
negative pressure room then ISO 7
11) vertical hood hazardous compounding-air flows
vertically
12) Horizontal Hood air flows horizontally across the work
, area from back to front
13) 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"
14) Negative Pressure room Hazardous materials
15) High-efficiency particulate air remove microbes > 0.3 micrometers
(HEPA) filters
16) Ante Room washing, garbing, product
decontamination
17) Buffer area air change per hour 30 exchanges per hour
(APCH)
18) ante room air change per hour ISO 8-20 per hour ISO 7- 30 per hour
(APCH)
19) Cleaning of compounding area germicidal detergent & water for visible
solids, 70% isopropyl alcohol
20) ISO Class 5 PEC cleaned beginning of each shift, before each
batch, every 30 minus when
compounding, after spills,
contamination
21) Cleaning of Counters and floors daily
of specific sites
22) Cleaning Walls, ceilings, storage monthly
shelving: