PTCB CSPT EXAM | TEST READY? ALWAYS. READY WITH OUR ACCURATE ANSWERS!

PTCB CSPT EXAM | TEST READY? ALWAYS. READY
WITH OUR ACCURATE ANSWERS!
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



aesptic - Answer: state of being free from microbial contamination



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)



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



APPHIA – Crafted with Care and Precision for Academic Excellence.
1

,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



ante room air change per hour (APCH) - Answer: ISO 8-20 per hour ISO 7- 30 per hour



Cleaning of compounding area - Answer: germicidal detergent & water for visible solids,
70% isopropyl alcohol



ISO Class 5 PEC cleaned - Answer: beginning of each shift, before each batch, every 30
minus when compounding, after spills, contamination

APPHIA – Crafted with Care and Precision for Academic Excellence.
2

, Cleaning of Counters and floors of specific sites - Answer: daily



Cleaning Walls, ceilings, storage shelving: - Answer: monthly



Suface sampling frequency - Answer: every 6 months or significant changes in procedure



Temperature of CSP areas - Answer: room temperature 20'C(68'F) or cooler



Airborne Particle Testing - Answer: every 6 months or device relocated or serviced



ISO class 5 Particle Limit for sterile compounding - Answer: 3,520 particles that are 0.5
micron or larger



ISO Class 7 Particle Limit for sterile compounding - Answer: 352,000 particles that are 0.5
micron or larger



ISO Class 8 Particle Limit for sterile compounding - Answer: 3,520,000 particles that are 0.5
micron or larger



ISO Class 5 Colony Forming Unit Action Level - Answer: 1 (>3)



ISO Class 7 Colony Forming Unit Action Level - Answer: 10-(>5)



ISO Class 8 Colony Forming Unit Action Level - Answer: 100 (>100)



Risk Level Classification - Answer: Low Risk, Medium Risk, High Risk, Immediate Use Risk
APPHIA – Crafted with Care and Precision for Academic Excellence.
3