USP 797 Compounding Clean Room

Softwall curtains (included on models below) create a separate ante-chamber.

Cleanroom Client List Dozens of customers for Terra modular cleanrooms

• Complete turnkey clean room meets Class 100 (ISO 5) cleanliness standards for control of submicron particles, ensuring a clean compounding environment
• Internal sliding curtain creates a separate gowning ante-room, in accord with USP 797 regulations
• Powder-coated steel support frame creates a rigid, durable structure that requires no external bracing or ceiling support
• Mirror-finish electropolished 304 stainless steel trim is easy to clean
• Clear polycarbonate and static-dissipative PVC panels stand up to IPA and other sterilizing agents

Terra's Compounding Clean Rooms provide the ideal environment for compounding sterile injectables and other critical operations.

Designed to meet the requirements of USP 797, they include three HEPA filter/fan units that provide a total of 1950 CFM (3315 m³/hr) of 99.99% particle-free air (measured at 0.3 µm diameter), far exceeding the ISO 7 condition stipulated by USP 797 for compounding clean rooms. In fact, the primary processing area meets ISO 5 (Class 100) cleanliness standards.

Select between 6'W x 8'L and 6'W x 10'L floor plans. Both rooms include a sliding clean vinyl curtain that creates a separate antechamber for personnel gowning or product staging. In the typical configuration, the primary compounding room accommodates a 6'-long workbench, which provides ample space for a laminar flow hood, as stipulated by USP 797 requirements (order bench and hood separately).

Hardwall designs are available with either rigid polycarbonate or static-dissipative PVC panels. Both offer superior resistance to chemicals, including alcohol and most germicides. By dissipating surface static charges that attract and hold particles, static-dissipative PVC also enhances contamination control. An external swing door is included. All units are 7' high (filter face to floor).

USP 797 Compounding Clean Rooms Panel Type Dimensions nominal Ft. (mm) Cat. # Price Hardwall Polycarbonate 8 x 6 (2438 x 1829) 2900-52A Details Hardwall Polycarbonate 10 x 6 (3048 x 1829) 2900-53A Details Hardwall SDPVC* 8 x 6 (2438 x 1829) 2900-54A Details Hardwall SDPVC* 10 x 6 (3048 x 1829) 2900-55A Details Includes (3) filter/fan units, (1) fluorescent light, Magnehelic® gauge, air speed gauge, internal roller-mount sliding curtain, 115V/60Hz duplex outlet, and external swing door *   See descriptions above.

Status light provides clear indication that fan filter units are in operation.