ptcb cspt exam questions and answers patient harme
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PTCB CSPT EXAM QUESTIONS AND ANSWERS
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
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
Suface sampling frequency
every 6 months or significant changes in procedure
Temperature of CSP areas
room temperature 20'C(68'F) or cooler
Airborne Particle Testing
every 6 months or device relocated or serviced
ISO class 5 Particle Limit for sterile compounding
3,520 particles that are 0.5 micron or larger
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