USP Chapter 797 describes the appropriate procedures and requirements for compounded sterile products (CSPs). It sets standards and lays out guidelines for any healthcare setting involved in CSPs. Failure to follow safe CSP practices can cause harm - even death - to patients due to microbial contamination, variation in the strength of ingredients, poor quality ingredients, or unintended chemical/physical contaminants.
USP 797 sets out a roadmap for achieving CSP control, which starts with good environmental design and engineering. Additionally, the human factor is critically important; properly trained and knowledgeable employees who understand and follow USP 797 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 CSP 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 separate compounding area, personnel must do the following:
- Remove any garments that do not meet the local cleanroom requirements
- Remove cosmetics
- Remove jewelry from hands, wrists, and any other visible body areas
2. Wear proper garb.
Regardless of risk level, personnel must wear shoe covers, face masks, hair covers and gowns. This is important because compounding personnel are the largest source of microbial and particulate contamination.
3. Wipe down products before bringing into the clean room.
Use a disinfectant solution such as 70% IPA or 1% fresh bleach solution before bringing any products into the clean room.
4. Don't touch hair or face while in the clean room.
Some studies show that human beings touch their face and hair several hundred times per day. All personnel who work in the clean room must be trained to be conscious of where their hands are, at all times. If a breach of aseptic procedure occurs, it must be noted and pointed out, then gloves should be disinfected and changed.
5. Perform daily cleaning.
The entire compounding environment, which includes the clean rooms and ante-rooms, must be disinfected on a regular basis. This includes floors, hoods and countertops. Make sure compounding staff uses the proper cleaning agents so that any and all microorganisms are eliminated.
6. Adopt USP 797 facility/engineering clean room guidelines.
Ensure that your facility has a modern clean room environment. Install HEPA filters in ceiling fans; replace non-compliant ceiling tiles with "clean room grade" tiles; replace floors with seamless vinyl flooring.
7. Implement a web-based software system to ensure USP 797 compliance.
What challenges do you have with clean room USP 797 compliance?