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USP 797 & USP 800: Choosing Cleanroom and Containment Equipment

What USP 797 and USP 800 cover

USP <797> sets the standards for compounding sterile preparations (CSPs); USP <800> sets the standards for safely handling hazardous drugs (HDs) to protect personnel, patients and the environment. Both chapters directly determine the equipment a US pharmacy or laboratory must install.

Primary engineering control (PEC) — the ISO Class 5 zone

Sterile compounding must take place inside a PEC that maintains ISO Class 5 air over the direct compounding area. Depending on the work, this is a laminar airflow workbench (clean bench), a compounding aseptic isolator (CAI), or — for hazardous drugs — a Class II biosafety cabinet or a compounding aseptic containment isolator (CACI).

Explore our laminar flow hoods and Class II biosafety cabinets used as primary engineering controls.

Secondary engineering control (SEC) — the cleanroom

The PEC normally sits inside a classified buffer room (typically ISO Class 7) served by an ante-room, with defined air changes per hour and pressure cascades between spaces. Our modular cleanrooms are built to ISO 14644 and can be configured for compounding suites.

USP 800 — hazardous drug containment

Hazardous drugs require a containment primary engineering control (C-PEC) — an externally vented Class II biosafety cabinet or a CACI — located in a containment secondary engineering control (C-SEC): a negative-pressure, externally vented room with a high air-change rate. Our CYTO-PURE cytotoxic cabinet is designed for this duty.

How to choose your equipment

For non-hazardous sterile compounding, a laminar airflow workbench or CAI inside an ISO 7 buffer room is typical. For hazardous drugs, you need an externally vented Class II cabinet (or CACI) inside a negative-pressure room — recirculating, room-vented devices are not acceptable for HDs.

Frequently Asked Questions

Can I use a laminar flow hood for hazardous drugs?
No. A laminar flow hood protects the product only and pushes air toward the room and operator. Hazardous drugs require a containment device — an externally vented Class II biosafety cabinet or a CACI.
What ISO class does the compounding area need?
The direct compounding area (the primary engineering control) must be ISO Class 5. The surrounding buffer room is typically ISO Class 7, with an ISO Class 7 or 8 ante-room.

Questions about your project?

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