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If your facility handles sterile pharmaceutical compounding, compliance with USP 797 and USP 800 is a must. These standards ensure safety and quality in environments where medications are prepared—protecting both patients and healthcare staff. One of the most critical areas in maintaining compliance is the USP 797 cleanroom, also known as the buffer zone.
USP Chapter 797 was first introduced in 2004 and sets national standards for pharmaceutical compounding of sterile preparations. It classifies compounding into three risk categories: Low, Medium, and High Risk. For each level, USP 797 outlines requirements for:
Staff training and responsibilities
Competency assessments
Environmental controls and quality assurance
Routine cleaning and disinfection
Monitoring and documentation
These guidelines are intended for a wide range of settings, including hospitals, pharmacies, and outpatient clinics—anywhere sterile drugs are mixed or handled.
The main goal of USP 797 is to reduce the risks of contamination, infection, and incorrect dosage when compounding sterile drugs. Whether your facility is a small compounding pharmacy or a large hospital, meeting the requirements of a 797 cleanroom is essential for patient safety and regulatory approval.
In fact, many state Boards of Pharmacy have adopted USP 797 into their regulations, either by referencing the standard directly or by creating their own state-specific requirements. For example:
Missouri and Texas have developed their own sterile compounding regulations.
New Jersey mandates that buffer zones meet ISO 6 / Class 1,000 standards.
In addition to state-level enforcement, the Joint Commission (JCAHO) also holds facilities to USP 797 standards and may even require stricter compliance than state regulations. Always consult your state’s Board of Pharmacy to understand the specific standards you must meet.
USP Chapter 797 refers to ISO 14644 cleanroom standards to define air cleanliness requirements for compounding environments. Here’s a breakdown of the ISO classes typically involved:
ISO 5 (Class 100): Where the actual sterile compounding occurs
ISO 7 (Class 10,000): Ante room or prep area (required as of 2006)
ISO 8 (Class 100,000): The buffer zone or cleanroom that surrounds the ISO 5 environment
A 797 cleanroom or buffer zone is designed to protect the sterile compounding area from contamination. It must be constructed from non-particle-generating, easy-to-clean materials and maintain positive pressure to prevent airborne contaminants from entering.
Barrier isolators may be used in place of a traditional cleanroom. However, unless the equipment manufacturer recommends it, these isolators do not need to be placed inside an ISO-rated space.
In simple terms, a buffer zone is the physical space that separates the sterile compounding area from the rest of the facility. To be USP 797 compliant, this area must meet certain ISO cleanliness standards and support continuous cleaning. The goal is to keep airborne particles within acceptable limits while minimizing contamination risks.
The good news? You don’t always have to start from scratch to meet USP 797 cleanroom requirements. Depending on your current setup, compliance might be achievable with a few targeted upgrades, such as:
Applying a water-based epoxy paint
Installing 1 to 3 new modular or fixed walls
Adding a cleanroom-rated ceiling system
Upgrading to HEPA-filtered air circulation
Installing a coved, seamless vinyl floor
These upgrades can often be installed in as little as 1–3 days, sometimes even over a weekend, helping minimize downtime. Whether you’re retrofitting an existing pharmacy or building a new compounding suite, Modular Cleanrooms offers economical solutions designed to work with your existing laminar flow hoods and facility layout.
Every facility is unique, and there’s no one-size-fits-all solution for USP 797 compliance. That’s why it’s so important to explore all your options. At Modular Cleanrooms, we can provide a preliminary cost estimate for your 797 cleanroom project within just 1–3 days. Our team is here to help you meet the strict requirements of USP Chapter 797 quickly, efficiently, and cost-effectively.
Ready to bring your facility up to USP 797 standards?
Contact us today to get started with your cleanroom design and implementation.
