Hand hygiene and garbing

Why Hand Hygiene and Garbing Matter

In sterile compounding, your hands and clothing are among the most significant sources of contamination. Human skin continuously sheds particles carrying bacteria and fungi. A single lapse in hand hygiene or garbing technique can introduce microorganisms into an intravenous preparation or other sterile product, putting a patient at serious risk of infection. USP General Chapter <797> sets the standards your facility must follow for sterile compounding, and demonstrating competency—including passing gloved fingertip sampling—is required before you are permitted to compound sterile preparations.

The Purpose of Each Garment

Every piece of protective attire serves a specific purpose:

• Shoe covers prevent organisms from the floor from traveling into the buffer area.
• Hair cover and beard cover (if applicable) contain shed hair and skin cells from the scalp and face.
• Face mask reduces droplets and aerosols from the nose and mouth.
• Gown is lint-free and covers your street clothes, which carry heavy bioburden.
• Sterile gloves are the last layer and the one tested by fingertip sampling.

All garb used in sterile compounding must be appropriate to the cleanroom classification. In a classified ISO 5 primary engineering control (PEC), sterile, powder-free gloves are required.

Correct Garbing Order

The order matters because you move from dirtiest to cleanest and from below upward before putting on the final sterile layer. A commonly accepted sequence is:

1. Remove jewelry, watches, and visible makeup; tie back or contain long hair.

2. Apply shoe covers (one at a time, keeping the covered foot off the floor before stepping into the ante-area).

3. Apply hair cover, ensuring all hair is enclosed.

4. Apply beard cover if applicable.

5. Apply face mask, securing it over the nose and mouth.

6. Perform hand hygiene (see next section).

7. Inspect hands and forearms for cuts, sores, or rash—report any open wounds to your supervisor, as this may prevent you from compounding.

8. Don the gown, fastening all snaps or ties without touching the outside of the gown with bare hands.

9. Perform a second, shorter hand-hygiene step at the sink just before entering the buffer room if required by your facility's SOP.

10. Don sterile gloves as the final step, using aseptic technique (touch only the cuff of each glove after the first glove is on).

Some facilities place eye protection after the mask. Always follow your site's written standard operating procedure (SOP); the SOP is the authoritative source at your facility.

Hand Hygiene Technique

USP <797> requires hand and forearm washing before entering the buffer area. Use an antimicrobial soap and water:

• Wet hands and forearms up to the elbows.
• Apply soap and scrub for at least 30 seconds, covering all surfaces: palms, backs of hands, between fingers, fingertips, thumbs, and forearms.
• Rinse thoroughly with water flowing from wrists toward the elbows (fingertips down) so contaminants rinse away from the clean area, not toward it.
• Dry with a non-shedding, single-use towel.
• Use a waterless alcohol-based hand rub (ABHR) after donning gloves and periodically during long compounding sessions, per your facility SOP.

Never use hand lotion before compounding—lotions deposit residue that contaminates the preparation.

Gloved Fingertip Sampling

Gloved fingertip and thumb sampling is the primary test of whether you have achieved and maintained aseptic technique. The procedure:

1. After full garbing, press the fingertips and thumb of each hand onto a prepared agar contact plate (tryptic soy agar is commonly used).

2. Apply firm, consistent pressure for the time specified in your facility SOP (commonly a few seconds per hand).

3. Label the plates and incubate them.

4. Results are read after the incubation period specified in the testing protocol.

Action limit: USP <797> establishes that for initial qualification (the first time you prove competency), the acceptable result is zero colony-forming units (CFU) on gloved fingertip samples. This is also the standard most facilities apply for routine requalification. Any growth means you must stop compounding, investigate your technique, remediate, and retest before resuming sterile work.

Safety Points

• Never remove your mask or gloves inside the buffer room and then re-enter without repeating the full garbing process.
• Replace torn or punctured gloves immediately.
• If you touch a non-sterile surface after gloving (e.g., a countertop outside the PEC), decontaminate gloves with sterile 70% isopropyl alcohol (IPA) or re-glove per your SOP.
• Under USP <800>, when handling hazardous drugs, a second pair of chemotherapy-rated gloves is required, and additional PPE such as a respirator may apply. Garbing requirements for hazardous drug compounding exceed those for standard sterile compounding.
• Document your garbing competency assessments. Facilities are required to reassess personnel at least annually (or more frequently per USP <797> requirements in effect at your facility).

Connecting to USP Chapters

• USP <795> governs non-sterile compounding; garbing requirements are less stringent but hand hygiene and gloves are still required.
• USP <797> governs sterile compounding and mandates the gloved fingertip sampling program described above.
• USP <800> layers additional requirements on top of <797> when hazardous drugs are involved.

Mastering hand hygiene and garbing is not a formality—it is a patient safety skill you will perform every working day.