Product Details
- Available Certified ISO Grade™ Designs: ISO 5, ISO 6, ISO 7, ISO 8
- Containment Room Dimensions: 10' W x 8' D x 8' H (3048 x 2438 x 2438mm)
- Ante-room Dimensions: 6' W x 8' D x 8' H (1829 x 2438 x 2438mm)
- ISO 5 Compounding room with ISO 7 Anteroom
- Materials: Powder-coated steel frame with center-mounted polypropylene panels provide clean, smooth interior surfaces that are easy to clean and sterilize
- Requires connection to in-house exhaust ventilation fan (not included); minimum required exhaust - 3640 CFM
- Negative pressure containment system meets requirements USP800 for hazardous drug compounding
- Meets USP compliance with Environmental Control System, which monitors room pressures, temperature, and humidity; included are two sensors and customer can choose between two versions with or without NIST certification
- Containment system ensures safe handling of hazardous drugs in conformance with USP 800
- Compounding rooms meet ISO 5 particle requirements, in accordance with USP 797 and USP 800
- Request UL Listing Declaration (order separately) for cleanroom electrical system, which helps meet municipal and other permitting requirements that may apply
- Compliance Notice: this clean room is built to the specifications of USP 800 as published in USP 40-NF 35; however, because practice standards vary from state to state and depend on compounding operations, Terra recommends consultation to evaluate suitability for your application
- Includes:
- (4) 2' x 4' Room Side Replaceable HEPA Fan Filter Units
- (5) LED Light panels and polypropylene ceiling panels in remaining ceiling bays
- (1) Duplex outlet 115VAC/60Hz
- (1) Power Distribution Module
- (2) Stainless Steel swing doors with partial view windows
- (1) Tempered glass viewing window per compounding room
- (1) Negative pressure exhaust plenum to ensure hazardous drug containment
- (2) Pressure, temperature, and RH sensors
- FDA-approved silicone sealant for caulking internal seams
- NOTE: Standard and/or extended warranty coverage for this cleanroom requires professional installation by Terra Universal. Consult your Terra representative for details.
Specs
• Application: USP 800 (Sterile HD)
• Frame Material: Stainless Steel
• Height: 8'
• Depth: 8'
• Width: 16'
• Overall Dimensions: 16' x 8' x 8'
• Panel Material: 304 Stainless Steel
• Unit of Measure: EA
• Marks & Listings: UL, ULC
• Electrical Specifications: 120 V, 50 A, 1 Ph, 60 Hz
• Weight, Shipping: 1,450 lb
