Sterile Preparations - NAPLEX

$2\ \text{mg/mL}$. Dividing total mass by volume yields concentration, ensuring accurate dosing in compounded preparations.

$\text{mOsmol/L}=\text{mmol/L}\times i$. Osmolarity accounts for particle dissociation, predicting solution tonicity for safe parenteral administration.

$\text{mEq}=\frac{\text{mg}\times \text{valence}}{\text{molecular weight}}$. This equation converts mass to equivalents based on ionic charge, essential for electrolyte balance in IV preparations.

$%\ \text{v}/\text{v}=\frac{\text{mL solute}}{\text{mL solution}}\times 100$. This formula measures the volume of liquid solute in the total solution volume, used for concentrations of miscible liquids.

$%\ \text{w}/\text{v}=\frac{\text{g solute}}{\text{mL solution}}\times 100$. This formula quantifies solute mass per unit volume of solution, expressing concentration as a percentage for pharmaceutical calculations.

Insert needle bevel up at about a $45^\circ$ angle, then straighten to $90^\circ$. This angle minimizes rubber coring by piercing rather than cutting, preserving vial integrity and preventing particulate contamination.

A component location that must remain sterile (e.g., needle, syringe tip, septum). Critical sites are vulnerable points where microbial entry could compromise the entire preparation's sterility.

Keep critical sites in first air; place items to the side and not upstream. Side placement prevents airflow obstruction, ensuring critical sites receive uninterrupted first air for aseptic protection.

The unobstructed HEPA-filtered airflow directly exiting the filter face. First air provides the cleanest, most direct HEPA-filtered airflow to critical sites, minimizing contamination risk.

BSC provides personnel/environment protection; LAFW protects product only. BSCs contain hazardous materials to protect the operator and surroundings, while LAFWs focus solely on product sterility without containment.

Scrub with sterile $70%$ IPA and allow to dry before puncture/breaking. Scrubbing removes surface contaminants, and drying ensures no residual moisture that could dilute or compromise sterility.

A $5\ \mu\text{m}$ filter needle or filter straw. A 5 μm filter captures glass shards ≥5 μm, preventing particulate contamination in the final preparation.

A Class II biological safety cabinet (BSC) or a compounding aseptic containment isolator. These PECs provide containment for hazardous drugs, ensuring personnel and environmental protection alongside product sterility.

An environment meeting ISO 14644-1 Class 5 particle limits at rest/operational. ISO Class 5 limits airborne particles to ≤3520 per cubic meter (≥0.5 μm) to maintain an aseptic environment for sterile compounding.

Shoe covers, head/facial hair cover, mask, hand hygiene, gown, sterile gloves. This sequence minimizes contamination by covering potential microbial sources before hand hygiene and final sterile barriers.

Sterile $70%$ isopropyl alcohol (IPA). Sterile 70% IPA effectively kills microbes on gloves without leaving residues, maintaining asepsis during the compounding process.

Hand and forearm wash, then dry with lint-free towel before gloving. Thorough washing removes dirt and microbes, followed by drying to prevent lint contamination before applying sterile gloves.

A preparation compounded in an aseptic environment to be free of viable microbes. Sterile preparations are compounded under controlled aseptic conditions to eliminate viable microorganisms and prevent patient infections.

$2\ \text{mL}$. Using the dilution formula $C_1V_1 = C_2V_2$ calculates stock volume needed to achieve the desired final concentration.

To provide ISO Class 5 unidirectional HEPA-filtered air over the work area. LAFW maintains an ISO Class 5 environment by directing HEPA-filtered air unidirectionally to minimize airborne contamination during compounding.

$2.5\ \text{mL}$. Dividing dose by stock concentration determines the precise volume required for administration.

From the HEPA filter at the back toward the operator (horizontal flow). Horizontal flow sweeps contaminants away from the critical work area by directing clean air from the rear HEPA filter toward the front.

From the HEPA filter at the top downward toward the work surface. Vertical flow pushes contaminants downward, ensuring the work surface receives clean air directly from the overhead HEPA filter.