USP 797
USP 797 is a set of guidelines developed to ensure the safe compounding of sterile medications in cleanroom environments. These standards define the conditions required to minimize contamination risks and protect both patient safety and product quality. Facilities that handle non-hazardous sterile preparations must follow USP 797 protocols for air cleanliness, pressure control, workflow, and personnel hygiene.
At Allied Cleanrooms, we design and build cleanroom environments that meet or exceed USP 797 requirements. Each space includes ISO-classified zones—such as ISO 5 primary engineering controls, ISO 7 buffer rooms, and ISO 8 ante-areas—strategically configured for proper airflow and contamination control. Our solutions also integrate pressure differentials, HEPA filtration, and environmental monitoring to ensure full regulatory compliance.
Whether you’re upgrading an IV compounding space or building a new sterile facility, our USP 797 cleanrooms are engineered for precision, safety, and long-term performance.
Cleanroom Zoning
USP 797 requires clearly defined ISO-classified areas, including ISO 5 compounding zones and supporting ISO 7 and ISO 8 spaces for proper airflow and contamination control.
Continuous Monitoring
We include regular air and surface sampling, pressure differential tracking, and documented monitoring protocols to ensure your facility remains USP 797 compliant.
Compliance-Ready Builds
Our cleanrooms are engineered for full USP 797 compliance, with layouts and systems designed to support sterile compounding and pass regulatory inspections with confidence.
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