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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.
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:
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.
Take the guesswork out of USP medication compounding compliance with a customizable, mobile, evidence-based solution.
Use a sporicidal disinfectant, EPA-registered disinfectant, or sterile 70% isopropyl alcohol (IPA) to wipe down any products entering the clean room. Personnel must wear gloves during this process and disinfectant agents must be allowed to dwell for sufficient contact time before moving products into the compounding area. These practices reduce bioburden and microbial contamination on supplies used for compounding.
The entire compounding environment, which includes the clean rooms and ante-rooms or the SCA, must be cleaned and disinfected daily on days when compounding occurs. This includes floors, pass-through chambers, and frequently touched work surfaces outside the hood. Additionally, ceilings, walls, shelving, and bins must be cleaned monthly. Sporicidal disinfectants must be applied at least monthly throughout the hoods and rooms. Sterile disinfectant and sporicidal agents are required for cleaning within the hoods. Pay attention to cleaning and disinfecting supplies, such as wipers, pads, and mop heads which must be low-lint, and disposable if possible. If cleaning tools are reusable, they must be dedicated for use within specific areas, not removed from classified areas or the SCA, and constructed from cleanable materials (avoiding porous materials like wood).
Ensure that your facility has a modern clean room environment. Install HEPA filters in the ceiling; evaluate the condition of walls and repair any dents or dings; replace floors with seamless vinyl flooring, ensuring the juncture between the floor and the walk is caulked and sealed. All surfaces must be maintained in good condition and resistant to damage from frequent cleaning applications.
Consider designing access doors to operate in a hands-free manner. This ensures a seamless and efficient transition between these spaces while minimizing the need for manual contact with the doors. When possible, pass-through chambers should be interlocking to prevent both sides from being opened at the same time.
All classified areas, including the hood, must be recertified every 6 months. This report includes validation of the air quality and airflow within the compounding area and is a key indicator that your cleanroom is in good working order. In the event something is out of specification, determine a corrective action plan and ensure follow-up occurs and is documented.
Make staff training and competency and compliance documentation more seamless by investing in an easy-to-use web-based pharmacy compliance system that helps staff achieve and maintain USP 797 compliance.
Take the guesswork out of USP medication compounding compliance with a customizable, mobile, evidence-based solution.
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