Product Details
- Available Certified ISO Grade Designs: ISO 4, ISO 5, ISO 6, ISO 7, ISO 8
- Containment Room Dimensions: 8'W x 12'D x 8'H (2438 x 3658 x 2438 mm)
- Ante-room Dimensions: 4'W x 12'D x 8'H (1219 x 3658 x 2438mm)
- Designed to exceed USP cleanliness and aseptic requirements.
- Components included:
- ✔ Room-side replaceable HEPA fan filter units (FFUs).
- ✔ Integrated LED lighting and ceiling panel system.
- ✔ Electrical package with power distribution and outlets.
- ✔ Swing doors with viewing panels and interior viewing window.
- ✔ Environmental monitoring system (pressure, temperature, and humidity sensors).
- Room Layout:
- ISO 7 USP 797 positive-pressure anteroom room. 4'W x 12'D x 8'H (1219 x 3658 x 2438mm)
- ISO 5 USP 800 negative-pressure hazardous compounding room. 8'W x 12'D x 8'H (2438 x 3658 x 2438 mm)
- Wall Design:
- BioSafe® modular wall panel system features coved corners on the ceiling and walls to maintain a flush finish.
- Fully monolithic and flush-mount connecting wall panel system (not a panel-post system with gaps and ledges).
- Seamless design is compliant with ISO-14644, cGMP, GLP, ASTM and IEST requirements.
- uPVC laminated and stainless steel surfaces are robust, easy to clean, and resists corrosion, abrasive chemicals and detergents.
- Walls have a plenum space to house utility and filling lines, providing convenient access to gas, vacuum, and water connections along with duplex outlets, control panels, and phone jacks.
- Wall panels feature fire-resistant aluminum honeycomb core. Available with optional FM4880 or FM4882 Approved designs.
- Ceiling Design:
- Room and ceiling is completely free-standing. The ceiling system is self-supported no suspension necessary.
- BioSafe® ceiling panel system is composed of the same monolithic BioSafe® Wall Panel System.
- Load-bearing and walkable ceiling panel system securely support FFUs; allows for easy access to equipment installed above the cleanroom and streamlined maintenance.
- Room Height:
- Specified internal height is 8' (2438 mm) from the floor to filter face. FFUs add 15" (381 mm) overhead clearance to this measurement.
- To ensure proper air flow and installation, allow an additional 13" (330 mm) between the top of the FFUs and the ceiling or other overhead obstruction (total of 26" - 660 mm - between the cleanroom filter face and the surrounding facility ceiling).
- Flooring:
- Flooring is not included. Room should be installed on a flat, sealed, non-particulating, non-porous, crevice-free surface, which can be caulked to the clean room frame to form a seal.
- Control Panel:
- 3.5" color touchscreen interface.
- Includes sensors to monitor each room with data logging (pressure, temperature, humidity).
- Night mode setting reduces energy consumption when cleanroom is not in operation.
- USP 800 Negative Pressure Room:
- Negative pressure containment system meets requirements USP 800 for hazardous drug compounding to ensure safe handling of hazardous drugs; air exhaust vents are adjustable to allow pressure balancing.
- Exhaust Requirements: USP 800 room requires connection to in-house exhaust ventilation fan (not included); minimum required exhaust - 2730 CFM.
- Compliance Notes:
- Verify before you buy: Consultation services available to ensure evaluate compliance with USP, cGMP, DQSA and other regulations. This clean room is built to the specifications of USP 797/800 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.
- Optional UL Listing Declaration (order separately) for cleanroom electrical system helps meet municipal and other permitting requirements that may apply.
- Warranty Note:
- Standard and/or extended warranty coverage for these cleanrooms requires professional installation by Terra Universal. Consult your Terra representative for details.
- 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: 12'
• Width: 12'
• Overall Dimensions: 12' x 12' x 8'
• Panel Material: 304/316L SS
• Unit of Measure: EA
• Marks & Listings: UL, ULC
• Electrical Specifications: 120 V, 50 A, 1 Ph, 60 Hz
• Weight, Shipping: 1,650 lb
