Chapter 797 of the United States Pharmacopeia (USP) outlines the correct procedures and requirements for preparing compounded sterile preparations (CSPs).
It establishes standards and provides guidelines for any healthcare setting engaged in the compounding of sterile products. Failure to adhere to safe CSP practices may result in harm, including death, to patients, attributable to factors such as microbial contamination, variability in ingredient strength, the use of substandard ingredients, or unintended chemical or physical contaminants.
USP 797 sets out a roadmap for achieving CSP control, which starts with good environmental design and engineering. Still, the human factor is critically important. Properly trained and competent employees are the key to CSP integrity and safety.
There are many detailed sections of USP 797. Let's address the clean room, a critically important area in USP compliance. Here are 7 USP 797 clean room guidelines that you and your staff must understand and follow.
1. Follow personnel cleaning and garbing procedures
Before entering the buffer area or the segregated compounding area (SCA), personnel must do the following to ensure effective fit of personal protective equipment and minimize the risk of contaminating the compounding environment:
- Remove any personal garments that do not meet the local cleanroom requirements
- Remove cosmetics
- Remove jewelry from hands, wrists, and any other visible body areas
- Remove nail polish and products
- Remove earbuds or headphones and leave any electronic devices not needed for compounding outside of the compounding area
- If worn, wipe eyeglasses with a suitable cleaner
2. Wear proper garb
Anyone entering the compounding area must wear low-lint shoe covers, face masks, hair covers and gowns, and sterile gloves. All garb must be sterile if performing category 3 compounding. Perform hand hygiene as described in facility standard operating procedures. These steps are important because compounding personnel are the greatest source of microbial and particulate contamination.
