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:

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 volume and frequency
• Types of HDs (chemotherapy, hormones, biologics, etc.)
• Whether sterile and non-sterile zones are both required
• Whether the current building supports exhaust routes, power, and structural loading

This step defines the project scale and avoids costly redesigns later.

Spatial Planning

Following USP 800 airflow and pressure requirements, we design a “clean to dirty” flow pattern:

Anteroom → Buffer Room → Compounding Room (C-PEC)

We ensure that:

• The buffer room meets ISO 7
• The compounding room maintains stable negative pressure
• Access control and personnel flow do not disturb airflow

If space is limited, Wonclean also provides compact layout solutions.

Equipment Selection & System Configuration

This stage focuses on selecting equipment and aligning mechanical systems:

• Class II BSCs, biosafety cabinets, or isolators
• Dedicated external exhaust systems
• Air valves, monitoring instruments, pressure gauges
• Rooftop or secondary exhaust fans if needed for long duct runs

We create tailored solutions based on the pharmacy’s operating model rather than a one-size-fits-all approach.

Construction & Commissioning

Construction covers far more than installation and includes:

• Sealing rooms (gaps, penetrations, pipe interfaces)
• Pressure balancing and airflow tuning
• Installing exhaust ducts and fire-rated sleeves
• Device certification (HEPA leak tests, airflow measurements)

A third-party verification follows to ensure long-term stability and compliance.

Training & Documentation

The final stage includes:

• Drafting SOPs (compounding, spill control, equipment use)
• Pre-employment and annual refresher training
• Record templates (pressure logs, cleaning logs, equipment certification, materials tracking)

This is one of the most overlooked—but essential—components of USP 800.

Conclusion

In short, USP 800 compliance is not achieved through a single piece of equipment—it requires a fully integrated system.

Wonclean’s mission is to help you build this compliance chain so it is stable, efficient, and easy to maintain.

If you’re planning a compounding room, upgrading a pharmacy, or need USP-standard cleanroom design, feel free to reach out—I can help you optimize your layout and system approach.

FAQs:

Q: What is the USP 800 standard?

A: USP 800 is a safety and engineering standard that governs the handling, storage, and compounding of hazardous drugs. It sets requirements for ventilation, pressure control, PPE, and workflow to protect healthcare workers and the environment. Any facility preparing HDs must follow USP 800.

Q: What is the difference between USP 800 and 797?

A: USP 797 focuses on sterile compounding quality and preventing microbial contamination, while USP 800 addresses hazardous drug safety and exposure control. Many facilities must meet both—797 ensures product sterility; 800 ensures worker and environmental protection.

Q: How does USP 800 relate to compounding?

A: USP 800 defines how hazardous drugs must be compounded, including engineering controls such as externally exhausted hoods, negative-pressure rooms, and specific HVAC requirements. It ensures HD compounding is safe for operators while maintaining proper containment.

Q: Does USP 800 apply to non-sterile compounding?

A: Yes. USP 800 applies to both sterile and non-sterile hazardous drug compounding. Non-sterile HD compounding must be performed in a negative-pressure room with at least 12 ACPH and an externally vented containment hood to prevent exposure and contamination.