Aseptic Technique in Sterile Compounding

What is aseptic technique?

Practices & procedures to prevent contamination from pathogens. Protects patients & ensures sterility of medical products.

According to USP <797>, where should a pharmacy technician gown and wipe down supplies for IV preparation?

Anteroom

What are the main sources of contamination in sterile compounding?

Environment (air), Equipment (sterilization), Personnel (touch is most common).

What does “sterile” mean?

Completely free of bacteria and other microorganisms.

What is the required environment for sterile compounding?

Class 100 environment → ≤100 airborne particles (≥0.5 micron) per cubic foot of air.

What is the correct order for donning PPE (garbing)?

Shoe covers → Hair cover → Mask → Gown → Sterile gloves.

Hand hygiene between steps, disinfect gloves with 70% isopropyl alcohol.

What is the correct order for removing PPE (doffing)?

Reverse of donning: Gloves → Gown → Mask → Hair cover → Shoe covers.

Perform hand hygiene throughout.

Why is proper disposal of PPE important?

Prevents cross-contamination and maintains sterile environment.

Step 1 of aseptic handwashing?

Remove jewelry, cosmetics, and personal items

Step 2 of aseptic handwashing?

Wet hands with warm water (avoid hot water to prevent irritation)

Step 3 of aseptic handwashing?

Use sponge/brush to clean under nails and scrub all surfaces

Step 4 of aseptic handwashing?

Rinse & dry with disposable towels

What is the minimum time for aseptic handwashing?

At least 30 seconds (about singing Happy Birthday twice)

Which regulatory body oversees GMPs & aseptic standards?

FDA

Which regulatory body sets facility standards for pharmaceutical facilities?

The Joint Commission

Which regulatory body implements guidelines for infection prevention & hospital controls?

CDC

Which USP chapter provides enforceable standards for sterile compounding?

USP <797>

Which organization provides QA guidelines for sterile products?

ASHP (American Society of Health-System Pharmacists)