PTCB HD flashcards
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- Primary engineering control (PEC)
- A device such as a laminar airflow workbench or biological safety cabinet that captures and removes airborne contaminants at the point of generation, providing ISO Class 5 air for sterile compounding.
- ISO Class 5 air
- Air quality containing no more than 3,520 particles per cubic meter of 0.5 micrometers or larger; the required condition inside a primary engineering control used for sterile compounding.
- HEPA filter efficiency
- A high-efficiency particulate air filter removes at least 99.97 percent of airborne particles 0.3 micrometers or larger; PECs and cleanrooms are certified with HEPA filtration.
- Negative pressure HD room
- A hazardous drug compounding area maintained at negative pressure relative to adjacent spaces so that airborne drug contamination does not escape into surrounding areas.
- Air changes per hour
- The number of complete room air exchanges hourly; a buffer/cleanroom requires at least 30 ACPH and a segregated compounding area at least 12 ACPH.
- Unidirectional airflow velocity
- Laminar airflow at the work surface of a primary engineering control should be about 0.2 meters per second (40 feet per minute), plus or minus 20 percent.
- PEC certification interval
- Primary engineering controls and cleanrooms are certified at least every six months and after relocation, repair, or major service that could affect airflow.
- Cleaning versus disinfection
- Cleaning removes organic soil and residue with a detergent; disinfection kills microorganisms on the surface. Both steps are required in sterile compounding areas.
- Sporicidal agent use
- A disinfectant that kills bacterial spores, such as sodium hypochlorite or hydrogen peroxide/peracetic acid, applied at a defined frequency because organic matter inactivates it.
- Disinfectant contact time
- The labeled dwell time a disinfectant must remain wet on a surface to achieve disinfection; surfaces are not considered disinfected before this time elapses.
- Clean-to-dirty cleaning order
- Surfaces are cleaned from the cleanest areas to the dirtiest and from top to bottom, with work surfaces and equipment before floors, to avoid recontamination.
- 70% isopropyl alcohol
- A disinfectant applied with friction to the work surface of a primary engineering control immediately before compounding and allowed to dry before use.
- Cleaning documentation log
- A record capturing date, time, cleaning agent, area cleaned, and initials; it supports compliance with USP requirements and facility standard operating procedures.
- Chemotherapy gloves
- Gloves meeting ASTM D6978 for hazardous drug resistance; worn as two pairs and changed every 30 minutes of HD contact or when torn or contaminated.
- Hazardous drug PPE
- Two pairs of chemo-rated gloves, a chemo-rated gown, an N95 or better respirator, and eye protection are required when handling hazardous drugs.
- Sterile gloves for compounding
- Gloves that are sterile and donned after hand hygiene; required for direct contact with sterile components during aseptic compounding.
- Respirator fit test
- A test confirming a respirator seals to the wearer's face; a user seal check is performed each time it is worn, and facial hair at the seal prevents proper fit.
- PPE donning order
- PPE is donned in the anteroom before entering the compounding area; sterile gloves are put on after hand hygiene and before touching sterile supplies.
- HD gown removal
- A chemo-rated gown is removed inside the compounding area and discarded as hazardous drug waste, followed by removal of gloves and hand hygiene.
- Refrigerated storage range
- Refrigerated drug products are stored at 2 to 8 degrees Celsius (36 to 46 degrees Fahrenheit); excursions are documented and may require quarantine.
- Controlled room temperature
- A storage range of 20 to 25 degrees Celsius (68 to 77 degrees Fahrenheit) for drug products labeled for controlled room temperature storage.
- Cold-chain transport
- Movement of temperature-sensitive products in validated containers with phase-change materials, keeping product from directly contacting dry ice or gel packs.
- Receiving inspection
- Checking incoming shipments for damage, tamper evidence, and temperature excursion indicators before acceptance; discrepancies are documented and product quarantined.
- Tamper-evident CSP container
- A sealed container for a compounded sterile preparation that shows evidence of opening and is labeled with beyond-use date, storage requirements, and patient identifiers.
- Low-risk CSP BUD
- For a low-risk sterile preparation without preservative: 48 hours at room temperature, 14 days refrigerated, and 45 days frozen from the time of compounding.
- Medium-risk CSP BUD
- For a medium-risk sterile preparation: 30 hours at room temperature, 9 days refrigerated, and 45 days frozen from the time of compounding.
- Final CSP check
- Verification of correct drug, dose, diluent, container, and label, plus visual inspection for particulates and container integrity before release.
- High-alert medication double-check
- An independent second verification of drug, concentration, and dose for medications such as insulin, heparin, and chemotherapy before dispensing.
- Prescription label elements
- Required label content includes patient name, drug name and strength, directions, quantity, date, prescriber, pharmacy, and a beyond-use or expiration date.
- USP 797 and 800 scope
- USP 797 sets standards for sterile compounding; USP 800 sets standards for hazardous drug handling throughout the facility, including storage and transport.
- Compounding competency interval
- Personnel are assessed for hand hygiene, garbing, and aseptic technique before independent compounding and at least every 12 months thereafter.
- Environmental monitoring program
- Surface and air sampling of compounding areas with results trended over time; out-of-limit results trigger investigation and documented corrective action.