Sterile Compounding Gowning and Garbing Procedures

Introduction

Sterile compounding is a critical healthcare practice that requires strict adherence to aseptic techniques to prevent contamination of medications. Proper gowning and garbing procedures are fundamental components of this process, designed to minimize the introduction of microbial and particulate contamination into the compounding environment.

These procedures, outlined in United States Pharmacopeia Chapter <797>, ensure that compounding personnel are properly equipped to prepare sterile medications safely. The effectiveness of these procedures directly impacts patient safety, as contaminated sterile preparations can cause serious patient harm, including life-threatening infections.

Hand Hygiene Technique

Proper handwashing is a critical first step in the gowning process:

• Remove watch and push up sleeves above forearms
• Wet hands and forearms with warm water
• Apply antimicrobial soap (preferably chlorhexidine gluconate 2%)
• Scrub thoroughly for at least 30 seconds, covering all surfaces of hands, fingers, forearms, and elbows
• Rinse hands and forearms with water in a downward motion, keeping hands higher than elbows
• Dry hands and forearms with paper towels using a blotting motion
• Use a paper towel to turn off the faucet
• Apply an adequate amount of alcohol-based hand sanitizer and allow to air dry completely

Gowning Procedure

The gowning process should follow a specific sequence:

1. Facial and Head Coverings

• Apply disposable face mask, ensuring it covers both nose and mouth completely
• Adjust ties to secure mask properly without creating gaps
• Don bouffant cap or hood, covering all hair including sideburns
• Adjust to ensure no hair is exposed

2. Shoe Covers

• Place shoe covers over shoes, ensuring they completely cover the feet
• Secure properly to prevent slipping
• Change shoe covers if they become torn or contaminated

3. Gown

• Open gown package without touching the inside surface
• Locate the inside edge of the neck opening and grasp
• Slide hands into sleeves without allowing fingers to protrude beyond sleeve cuffs
• Adjust gown to fit properly
• Secure neck ties first, then waist ties
• Some gown designs require an assistant to secure waist ties to prevent contamination

4. Gloves

• Open glove package, being careful not to touch outside surface
• Grasp first glove by folded edge and don onto dominant hand
• Use gloved hand to don second glove by sliding fingers under folded edge of second glove
• Adjust gloves to fit properly over gown cuffs
• For chemotherapy hazardous compounding, double-gloving is required

Common Gowning Errors

Personnel should avoid these common mistakes:

• Talking or coughing excessively in the compounding area
• Touching non-sterile surfaces with gloved hands
• Allowing sleeves to pull back and expose arms
• Wearing jewelry under gown or gloves
• Failing to properly secure masks or hoods
• Improper hand hygiene techniques
• Excessive movement within the compounding environment
• Touching hair or face while in gown

Gowning Proficiency Assessment

Pharmacy personnel must undergo regular training and competency assessment in gowning and garbing procedures:

• Initial training and demonstration of competency before performing compounding
• Annual competency assessment thereafter
• Documentation of training and assessment results
• Immediate retraining if contamination events occur
• Regular observation to ensure continued proper technique

Degowning Procedure

When leaving the compounding area:

• Remove gloves first, disposing of appropriately
• Untie gown at waist followed by neck
• Remove gown carefully to minimize contamination
• Remove shoe covers
• Remove face mask and head covering
• Perform hand hygiene

Quality Assurance

To ensure ongoing compliance with proper gowning and garbing:

• Implement regular monitoring of personnel compliance
• Conduct periodic environmental sampling to detect contamination
• Perform media fills to assess aseptic technique proficiency
• Document all training and competency assessments
• Address any deviations from established procedures promptly

Conclusion

Proper gowning and garbing procedures are essential elements of aseptic technique in sterile compounding. These standardized protocols minimize contamination risk and help ensure patient safety by maintaining the integrity of compounded sterile preparations. Regular training and competency assessment reinforce the importance of these procedures and promote consistent practices among compounding personnel. By adhering to these guidelines and continually refining techniques, healthcare professionals can maintain the highest standards of sterile compounding practice.