USP 800 Compliant Compounding Spaces

Let’s start by answering the question everyone asks first: “What exactly is USP 800?” In the cleanroom industry—especially pharmacy compounding and hospital pharmacy operations—it is both a safety rule and an engineering standard. As a cleanroom engineering and solution provider, Wonclean will break down the core concepts of usp 800 and the essential design requirements in a light yet rigorous way. What is USP 800? USP 800 is a standard specifically created to regulate the compounding, storage, and handling of Hazardous Drugs (HDs). Its primary goal is to protect healthcare workers, patients, and the environment. It works alongside USP 795 and USP 797, and in the U.S. healthcare system, it is considered a mandatory engineering and operational requirement. To make things clearer, USP 800 focuses on three major areas: Engineering controls (ventilation, cleanroom structure, exhaust, pressure control) Environmental controls (particle levels, temperature and humidity, ISO classification) Administrative controls (PPE, training, documentation) Key Requirements of USP 800 Engineering Control Essentials Below is a simplified version of the engineering requirements that Wonclean commonly uses when designing USP 800 facilities for hospitals and pharmacies: Area Pressure Air Changes (ACPH) Exhaust HD Storage Negative ≥12 ACPH External, no recirculation Non-Sterile HD Compounding Negative ≥12 ACPH External exhaust Sterile HD Buffer Room Negative, ISO 7 ≥30 ACPH Dedicated external exhaust Anteroom Positive, ISO 7 ≥30 ACPH Recirculation allowed The most critical point: All HD compounding must be done in externally exhausted equipment such as a pharmacy compounding hood (BSC or other externally vented C-PECs). What does USP 800 Compliance Require? USP 800 compliance is a system-level engineering effort—it is not “just buying a hood.” Wonclean typically plans a project with the following structure: Facility & Equipment Select Class II BSCs or isolators Equipment must be externally vented, never recirculated Position away from doors, vents, or airflow disturbances HVAC & Pressure Control Maintain -0.01 to -0.03 inH₂O in HD rooms 30 ACPH is required for ISO 7 sterile compounding rooms Exhaust points must be far from air intakes; buildings should reserve shaft space Administrative Controls USP 800 requires implementation of the following administrative measures: Annual training (HD handling, spill management, PPE donning/doffing) Continuous pressure monitoring and documentation Annual certification of containment devices (HEPA leak test, airflow testing) Updating HD inventory lists and performing risk assessments These administrative controls ensure engineering systems are properly used and remain stable. How to Design a USP 800 Space Based on years of cleanroom engineering experience, Wonclean usually follows a structured workflow during USP 800 projects: Needs Assessment This begins with detailed, checklist-style communication to determine: Compounding vol...