Aseptic Technique in Sterile Compounding

Overview

This lecture covers aseptic technique in sterile compounding, crucial for pharmacy technicians, with a focus on standards, equipment, sterile procedures, risk levels, and regulatory guidelines for preparing parenteral medications.

Importance of Aseptic Technique

• Parenteral medications must be sterile as they are injected directly into the bloodstream.
• Contaminated or incorrect doses can cause serious or fatal reactions.
• Aseptic technique eliminates contamination risks during compounding.

Key Terminology & Abbreviations

• Ampule: Glass container (1-50 mL) for medication.
• MDV (Multi-Dose Vial): Contains multiple doses.
• SDV (Single Dose Vial): Holds one dose.
• D5W: 5% dextrose in water; D5NS: 5% dextrose in normal saline.
• IV (intravenous), IM (intramuscular), ID (intradermal), IT (intrathecal), subcut (subcutaneous), IV push, PRN, NPO.

Aseptic Compounding Supplies & Equipment

• Clean rooms and laminar flow hoods are required for sterile compounding.
• Hoods are cleaned with 70% isopropyl alcohol and must be certified every 6 months.
• Common tools: syringes (0.5–60 mL), needles (16–20 gauge), filter needles, ampule breakers, forceps, transfer needles.
• Only essential items for immediate use are allowed in clean rooms.

Regulatory Standards (USP 797)

• Three risk levels: low (minimal manipulation), medium (bulk compounding), high (exposed to non-sterile conditions).
• Regular training, annual media fill tests, and air sampling are mandatory.
• Clean room areas: ante room (gowning), buffer/clean room (compounding), airlocks for pressure control.
• Hoods: horizontal for non-hazardous, vertical (BSC/CACI) for hazardous drugs like chemotherapy.

Procedures for Aseptic Compounding

• Hand hygiene, proper gowning, and cleaning of work surfaces are critical steps.
• Never recap used needles; discard in Sharps container.
• Use filter needles for ampule solutions to avoid glass contamination.
• Remove equal air volume when adding diluent to vials to avoid pressure buildup.

Special Preparations & Devices

• TPN (Total Parenteral Nutrition) and PPN (Peripheral Parenteral Nutrition) are compounded for patients unable to eat.
• Only regular insulin can be added to IV solutions.
• Patient-controlled analgesia (PCA) pumps deliver preset doses for pain management.

Hazardous Drug Handling (USP 800)

• Hazardous and non-hazardous drug storage/prep must be separated.
• Compounding chemotherapeutic agents requires specialized PPE, double gloves, closed-system transfer devices, and strict protocols.

Labeling & Documentation

• Labels must include drug, patient, concentration, expiration, preparer initials, and pharmacist verification.
• Discard unused or contaminated products properly.
• Document all training, test results, and compliance with standards.

Key Terms & Definitions

• Aseptic Technique — Procedures to prevent contamination of sterile products.
• Clean Room — Controlled area for sterile compounding.
• Laminar Flow Hood — Device providing sterile air flow over work area.
• HEPA Filter — High-efficiency filter removing particles ≥0.3 micrometers.
• Media Fill Test — Quality assurance procedure mimicking compounding to check for contamination.
• Critical Site — Area exposed to direct contact during compounding (e.g., needle, vial entry).
• First Air — Clean HEPA-filtered air contacting sterile products.

Action Items / Next Steps

• Review USP 797 and USP 800 guidelines.
• Practice sterile compounding procedures and hand hygiene.
• Prepare for annual media fill tests and training assessments.
• Memorize abbreviations, routes, and supply identification for IV preparation.