PTCB CSDP flashcards
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32 cards. Read the term and the definition here. The deck at the top of this page is optional.
- ISO Class 5
- Air quality standard for the direct compounding area (critical zone) in sterile compounding, allowing no more than 3,520 particles of 0.5 micron or larger per cubic meter.
- HEPA filter efficiency
- High-efficiency particulate air filters remove at least 99.97% of airborne particles 0.3 micron or larger, protecting the critical zone from contamination.
- Primary engineering control
- A device or room that provides the ISO Class 5 environment for sterile compounding, such as a laminar airflow workbench, biological safety cabinet, or isolator.
- Buffer room pressure
- The buffer room must be at positive pressure relative to adjacent unclassified areas for non-hazardous compounding, and at negative pressure for hazardous drug compounding.
- Certification frequency
- Primary engineering controls and buffer rooms must be certified at least every six months and after relocation or significant repair or service.
- First-air rule
- Critical sites of sterile components must be exposed only to first air, meaning HEPA-filtered air that has not passed over any other object.
- Critical site
- Any surface or opening that must remain sterile to prevent contamination, such as a needle hub, vial septum, ampule neck, or syringe tip.
- Ampule filter needle
- A needle or straw containing a filter (typically 5 micron) used to withdraw solution from an ampule and remove glass particles before administration.
- Garbing sequence
- Order of donning PPE: shoe covers, head cover, beard cover, mask, hand hygiene, sterile gown, then sterile gloves without touching the exterior.
- Septum disinfection
- Swab the vial septum with 70% isopropyl alcohol and allow it to dry before inserting a needle, reducing microbial contamination risk.
- Single-dose vial policy
- A single-dose vial is intended for one patient only and should not be reused for additional patients, even if residual drug remains.
- NIOSH hazardous drug criteria
- Drugs are hazardous if they are carcinogenic, teratogenic, reproductive toxins, organ toxic at low doses, or genotoxic, per NIOSH criteria.
- Closed system transfer device
- A CSTD mechanically prevents the transfer of hazardous drug contaminants into the environment and protects the operator during compounding and administration.
- Hazardous drug PPE
- Includes two pairs of chemotherapy-tested gloves, a chemo gown, a NIOSH-approved respirator, and eye/face protection during hazardous drug handling.
- Hazardous drug spill kit
- A kit containing absorbent pads, chemo gown, gloves, and disposal bags used to contain and clean hazardous drug spills safely.
- Containment isolator
- A negative-pressure isolator with HEPA filtration used for hazardous drug compounding to protect both the operator and the environment.
- Sterilization vs disinfection
- Sterilization destroys all microorganisms including spores; disinfection reduces pathogens but does not necessarily kill spores.
- Autoclave parameters
- Standard moist-heat sterilization uses 121 degrees C at 15 psi for 15-30 minutes, or 134 degrees C for shorter cycles, destroying all microorganisms.
- High-level disinfection
- A process using sporicidal agents such as hydrogen peroxide or glutaraldehyde to destroy all microorganisms except high numbers of bacterial spores.
- 0.22 micron filter
- A sterilizing-grade filter used to remove bacteria and particulates from heat-labile solutions during sterile compounding.
- Hand hygiene
- The single most effective infection-control measure; performed before and after gloving and after contact with contaminated items or surfaces.
- USP <797>
- The United States Pharmacopeia chapter governing sterile compounding practices, including facility, personnel, and environmental monitoring requirements.
- USP <800>
- The USP chapter setting standards for safe handling of hazardous drugs, including engineering controls, PPE, and work practices.
- Low-risk BUD
- For low-risk CSPs: 48 hours at room temperature, 14 days refrigerated, and 45 days frozen, per USP <797>.
- Medium-risk BUD
- For medium-risk CSPs: 30 hours at room temperature, 9 days refrigerated, and 45 days frozen, per USP <797>.
- High-risk BUD
- For high-risk CSPs: 24 hours at room temperature, 3 days refrigerated, and 45 days frozen, per USP <797>.
- Media fill test
- A gloved fingertip and thumb sampling test performed to verify that personnel can compound without contaminating the sterile product.
- Dose formula
- Dose = (Desired dose / Have) x Quantity, used to calculate the volume or amount of drug to prepare for a prescribed dose.
- Alligation method
- A calculation technique that mixes two concentrations to reach a desired strength: (higher - desired) : (desired - lower) gives the ratio of parts.
- Percent w/v solution
- A concentration expressed as grams of solute per 100 mL of solution; for example, 5% w/v contains 5 grams per 100 mL.
- mEq formula
- mEq = (mg x valence) / atomic weight, used to convert between milligrams and milliequivalents for electrolytes such as sodium and potassium.
- IV flow rate formula
- Flow rate in mL/hr = total volume in mL divided by total time in hours; drop rate = (volume x drop factor) / time in minutes.