PTCB CSPT EXAM with Verified Answers Graded A+
1. Patient harmed by compound- microbial contamination, excessive bac-
ed sterile preparations terial endotoxins, variability in strength
of ingredients, chemical/physical contami-
nants, inappropriate quality of ingredients
2. non sterile compounding ex- products used orally, topically on skin or to
amples fill gaps when not commercially available
3. aesptic state of being free from microbial contam-
ination
4. sterile compounded items injections(iv, etc) ophthalmic drops, aque-
ous bronchial or nasal inhalations, baths
for live organs, tissue implants, irrigation
for wounds or cavities
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 workbench-
es (LAFWs), biological safety cabinets
(BSCs), compounding aseptic isolators
(CAIs), and compounding aseptic contain-
ment isolators (CACIs).
8. secondary engineering con- the ante area and buffer area
trols
9. Buffer or Clean Room ISO 7
10. Ante Room ISO class ISO 8, unless provides access to negative
pressure room then ISO 7
16. Ante Room washing, garbing, product decontamina-
tion
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 daily
floors of specific sites
22. Cleaning Walls, ceilings, stor- monthly
age shelving:
23. Suface sampling frequency every 6 months or significant changes in
procedure
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