Wednesday Exam: PHA 359 Dispensing & Patient Care Flashcards

50 vocabulary flashcards covering key concepts, numerical values, and definitions from PHA 359 Dispensing & Patient Care objectives.

Parenteral Preparation

A dosage form administered by a route outside the intestinal tract, which does not automatically imply that it is sterile.

Compounded Sterile Preparation (CSP)

A sterile preparation compounding from sterile components or sterilized after compounding, as appropriate.

Injectable Product Forms

The five injectable product forms listed in the course slides: injection, for injection (powder for solution), injectable emulsion, injectable suspension, and for injectable suspension.

Intramuscular (IM) Volume Maxima

Illustrative teaching volume limits of about $5\,\text{mL}$ in the gluteus maximus and $2\,\text{mL}$ in the deltoid or vastus lateralis.

Subcutaneous (SQ) Volume Maximum

An illustrative teaching volume limit of up to $2\,\text{mL}$ (often closer to $1\,\text{mL}$).

Intradermal (ID) Volume Maximum

An illustrative teaching volume limit of about $0.1\,\text{mL}$.

Parenteral Onset of Action Ranking

The ranking of onset speed across parenteral administration routes: $\text{IV} > \text{IM} > \text{SQ} > \text{ID}$.

USP Chapter

The United States Pharmacopeia chapter that covers standards for nonsterile compounding.

USP Chapter

The United States Pharmacopeia chapter setting minimum practice and quality standards for sterile compounding.

USP Chapter

The United States Pharmacopeia chapter setting practice standards for hazardous drug handling for both sterile and nonsterile products.

Needle Components

The structural parts of a needle: hub, shaft, lumen, bevel, tip, and heel.

Needle Gauge

The measurement of needle lumen size, where a higher gauge number indicates a smaller lumen size ($18\,\text{G}$ is common in this course).

Filter Needle / Filter Straw

A specialized supply used to withdraw solution from a glass ampule, which must be replaced with a regular needle before ejecting the solution.

Syringe Components

The structural parts of a syringe: tip, barrel (calibrated hollow cylinder), plunger, collar, and flange.

Open System (Parenteral)

A container system defined by the free exchange of air, such as an opened glass ampule.

Closed System (Parenteral)

A container system closed to room air until accessed, such as a sealed vial or plastic IV bag.

Closed-System Transfer Device (CSTD)

A mechanical transfer device for hazardous drugs that limits environmental contaminants from entering and prevents hazardous drug or vapor from escaping.

Small-Volume Parenterals (SVPs)

Parenteral preparations containing a total volume of at most $100\,\text{mL}$.

Large-Volume Parenterals (LVPs)

Parenteral preparations containing a total volume of greater than $100\,\text{mL}$.

Multidose Vial In-Use Limit

A maximum $28$\text{-day} limit after initial entry unless otherwise specified by the manufacturer, requiring a disinfected stopper at each puncture.

Sterility

The total absence of viable microorganisms, which cannot be established by physical appearance alone.

Endotoxin

A potent, heat-stable lipopolysaccharide pyrogen derived from gram-negative bacteria that is not removed by ordinary sterilization.

Pyrogens

Fever-producing substances contaminating a parenteral product.

ISO Classification Particle Measurement Size

Airborne particle size standard measuring particles at least $0.5\,\mu\text{m}$ per cubic meter, where a lower ISO number indicates cleaner air.

Disinfectant vs. Antiseptic

A disinfectant is an agent applied to inanimate surfaces, whereas an antiseptic is applied to living tissue.

Preferred Surface Disinfectant

Sterile $70\%$ isopropyl alcohol (IPA), which is effective for critical surfaces but is not sporicidal.

Surface Disinfection Contact Times

Required wet contact times of at least $30\,\text{seconds}$ for general surfaces and at least $10\,\text{seconds}$ for vial, ampule, and port surfaces prior to drying.

Primary Engineering Control (PEC)

A compounding device or zone providing an $\text{ISO Class 5}$ or cleaner environment where critical manipulations are conducted.

Secondary Engineering Control (SEC)

The area or room containing the PEC, such as a cleanroom suite (anteroom and buffer room) or a segregated compounding area (SCA).

Nonhazardous Category 2 Suite ISO Requirements

A cleanroom suite comprised of an $\text{ISO Class 8}$ or cleaner anteroom, an $\text{ISO Class 7}$ or cleaner buffer room, and an $\text{ISO Class 5}$ PEC.

Horizontal Laminar Airflow Pattern

Airflow originating from a rear HEPA filter flowing forward toward the operator, requiring critical sites to be kept clear of downstream turbulence behind objects.

Vertical Laminar Airflow Pattern

Airflow descending from above, requiring critical sites to be kept clear of downstream turbulence below objects.

Direct Compounding Area (DCA) Horizontal Clearance

The designated work region located about $6\,\text{inches}$ inside the sides and front edge of the workbench, and $3\,\text{inches}$ from the HEPA filter.

PEC Cleaning Sequence

Cleaning from cleanest to dirtiest, top to bottom, and back to front, using straight overlapping strokes with a fresh wipe per surface.

PEC Sporicidal Application Frequency

Required sporicidal agent application performed monthly for Category 1 and Category 2 PECs, and weekly for Category 3 PECs.

Nonhazardous Suite Pressure Differentials

Positive pressure differentials maintaining $+0.02\,\text{inch water column}$ in the anteroom and $+0.04\,\text{inch water column}$ in the buffer room.

Hazardous Buffer Room Pressure Differential

A negative differential pressure maintained between $-0.03$ and $-0.01\,\text{inch water column}$ relative to adjacent areas.

PEC/SEC Recertification Frequency

Mandatory testing performed prior to initial use, at least every $6\,\text{months}$, and after structural or airflow-altering modifications.

Dynamic Smoke-Pattern Study

A certification test conducted under operating or simulated conditions to verify that HEPA-filtered first air sweeps over and away from critical site preparations.

Immediate-Use CSP

A CSP prepared outside a PEC during urgent clinical scenarios using no more than $3$ sterile products, with administration beginning within $4\,\text{hours}$ of starting preparation.

Category 1 CSP

A CSP compounded in an $\text{ISO Class 5}$ PEC (potentially in an SCA) with maximum BUD limits of less than $12\,\text{hours}$ at room temperature or $24\,\text{hours}$ refrigerated.

Category 2 CSP

A CSP prepared in an $\text{ISO Class 5}$ PEC within an $\text{ISO Class 7}$ buffer room and $\text{ISO Class 8}$ anteroom, eligible for longer BUDs based on sterilization and testing.

Category 3 CSP

A CSP prepared in a classified cleanroom suite under maximum controls, requiring stability-indicating formulation data and batch sterility/testing before release.

Gloved Fingertip and Thumb Sampling (GFT) Limits

Competency sampling requirement where initial post-garbing testing requires $0\,\text{CFU}$, and post-compounding testing action level is $\ge 3\,\text{CFU}$ total across both hands.

Surface Viable Sampling Action Levels

Action thresholds per device: $> 3\,\text{CFU}$ for $\text{ISO Class 5}$, $> 5\,\text{CFU}$ for $\text{ISO Class 7}$, and $> 50\,\text{CFU}$ for $\text{ISO Class 8}$.

Air Viable Sampling Action Levels

Action thresholds per device: $> 1\,\text{CFU/m}^3$ for $\text{ISO Class 5}$, $> 10\,\text{CFU/m}^3$ for $\text{ISO Class 7}$, and $> 100\,\text{CFU/m}^3$ for $\text{ISO Class 8}$.

Critical Sites

Fluid-path locations including vial rubber septa, bag additive/administration ports, needle tips/bevels/shafts, syringe tips/plungers, and ampule openings that must not be touched or blocked from first air.

Hazardous Cleanroom C-SEC Requirements

An $\text{ISO Class 7}$ externally exhausted negative-pressure buffer room ($-0.03$ to $-0.01\,\text{inch water column}$) featuring greater than $30\,\text{air changes per hour}$.

Hazardous Segregated Compounding Area (C-SCA) Requirements

An unclassified fixed-wall room vented externally under negative pressure ($-0.03$ to $-0.01\,\text{inch water column}$) with greater than $12\,\text{air changes per hour}$.

Four Steps of Hazardous Cleaning

The sequential hazardous cleaning process: 1. Deactivation, 2. Decontamination, 3. Cleaning, and 4. Disinfection.