PTCB CSPT EXAM WITH 100% VERIFIED 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 Non hazardous hoods Laminar airflow workbench (LAFW) compounding containment isolator (CAI) Hazardous hoods biological safety cabinet (BSC) compounding aseptic containment isolator (CACI) 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 vertical hood hazardous compounding-air flows vertically Horizontal Hood air flows horizontally across the work area from back to front 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" Negative Pressure room Hazardous materials High-efficiency particulate air (HEPA) filters remove microbes 0.3 micrometers Ante Room washing, garbing, product decontamination Buffer area air change per hour (APCH) 30 exchanges per hour ante room air change per hour (APCH) ISO 8-20 per hour ISO 7- 30 per hour Cleaning of compounding area germicidal detergent & water for visible solids, 70% isopropyl alcohol ISO Class 5 PEC cleaned beginning of each shift, before each batch, every 30 minus when compounding, after spills, contamination Cleaning of Counters and floors of specific sites daily Cleaning Walls, ceilings, storage shelving: monthly 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 ISO Class 7 Particle Limit for sterile compounding 352,