Stainless Steel USP 797 and USP 800 Cleanrooms
Fullerton, CA – Stainless steel cleanrooms from Terra Universal meet USP 797 and USP 800 pharmacy compounding requirements. These secondary engineering controls (SEC) maintain pressure and cleanliness ratings. Rooms have ante- and buffer chambers with pressure differentials that control circulating particles and meet current Good Manufacturing Practices mandated by the FDA.
Both USP 797 and USP 800 modular cleanrooms are made of stainless steel panels with tempered glass doors and windows. These materials are non-outgassing, non-porous and will not generate particles. They also withstand frequent sterilization. The modular steel panels are free-standing, connecting together using a snap-in-place system. This construction creates a double-walled, insulated enclosure.
USP 797 rooms are positive pressure and used for non-hazardous drug compounding. USP 800 rooms maintain negative pressure and are designed for hazardous-drug compounding. Some USP 800 cleanrooms will also have positive-pressure ante chambers, depending on the type of drug being compounded.
Both room types come with fan/filter units to provide required air flow and remove circulating particles. They are also equipped with fluorescent ceiling lighting; a stainless steel ceiling grid supports all overhead modules. An environmental monitoring system is standard equipment with all USP 800 rooms. It helps maintain critical specifications and engage an energy-saving set-back mode for off-shift hours. Data logging, using an Ethernet connection, documents environmental settings and system status.
Terra Universal has 40 years of experience manufacturing controlled, ISO-rated enclosures. Visit Terra Universal’s website for more information about their USP-Compliant 797 and 800 Cleanrooms.