HealthOctober 31, 2014

How to stay compliant with USP 797

The human body is a prodigious particle carrier and shedder. We hold about 150 to 200 different bacteria classes, our hands have on average 100,000 organisms per square millimeter, and we shed five grams of skin each day.1 These particles can and do contaminate compounded sterile preparations (CSPs), causing serious patient injury or even death. Ensuring that your CSPs are prepared in an appropriately safe and sterile environment that minimizes the chances of dangerous contaminants requires a systematic process and ongoing vigilance.

The vehicle for managing compounding risk is compliance with USP 797, an enforceable set of compounding standards that lay out the guidelines and procedures for healthcare facilities that prepare CSPs.

Achieving compliance begins with a facility that has solid environmental design and engineering. Key elements of a USP 797-compliant sterile compounding facility include a compounding area appropriate to the hospital's risk level, proper air quality management systems, personnel training and a pharmacy compliance software system to track and manage compliance. Here are five important elements of USP 797 compliance:

Engineer to a minimum ISO Class 5 Space

At a minimum, USP 797 sterile compounding facilities must meet ISO or Class 5 requirements as a primary engineering control (PEC). This is the space for actual sterile compounding occurs and should allow no more than 3,520m2 particles per square meter of air that is moving unidirectionally.1 Laminar airflow workbenches, compounding aseptic isolators and biological safety cabinets are examples of common ISO Class 5 spaces. An ISO Class 7 environment is necessary for buffer and cleanroom areas.

Air quality

This is one of the biggest factors influencing the chance of microbial contamination. Air cleanliness and quality is one of the leading factors in the development of cleanrooms. There are a variety of methodologies to achieve appropriate air ventilation. These include the installation of integrated high-efficiency particulate air (HEPA) filters, adding filters to ceiling fans, and replacing older ceiling tiles with plastic-covered clean room grade tiles.2

Allow ISO Class 5 engineering control (EC) units to run for a minimum of 30 minutes before use

To pull out air in the internal ducts and particles inside the aseptic compounding area, it's important to let EC units operate for at least 30 minutes before beginning compounding.3

Document refrigerator and freezer temperatures daily

Improperly stored compounding ingredients, medications or CSPs can lead to microbial growth and contamination. Make sure you have a system in place to check and document temperatures each day for all refrigerators and freezers used to store such items.3

Minimize product movement

By optimizing your facility's layout, you minimize the movement of products from one step to another. Think about your physical layout and consider whether it ensures an efficient workflow and minimizes contamination risks.4


1. Kastango, Eric S. The Top 10 Things You Need to Know About USP <797>. Infusion. Continuing Education. May/June 2009.
2. The ASHP Discussion Guide for Compounding Sterile Preparations. Pg. 4.
3. Kastango, Eric S. 33 Tips for USP <797> Success. Pharmacy OneSource Inc.
4. Kastango, Eric S. 10 Tips for a  More Efficient USP 797 Compliant Cleanroom. 2010, ClinicalIQ, LLC.

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