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 2438mm)
Ante-room Dimensions: 4' W x 12' D x 8' H (1219 x 3658 x 2438mm)
• Application: USP 797 (Sterile)
• 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
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Terra Part #: 2900-94-SS
Manufactured By: Terra Universal
Warranty: 1 year parts, 90 days labor
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Summary
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 2438mm)
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 797 positive-pressure sterile compounding room. 8' W x 12' D x 8' H (2438 x 3658 x 2438mm)
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.
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.
Specifications
• Application: USP 797 (Sterile)
• 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, 1 Ph, 60 Hz
• Weight, Shipping: 1,650 lb
Features and Benefits
Accredited Technical Cleanroom Expertise
We are committed to provide our clients with a full service solution, from project planning through engineering, product design, manufacturing, procurement, shipping, installation, validation, commissioning, and preventative maintenance. Our team of qualified professionals collaborates with all stakeholders to deliver innovative solutions at every stage of the project.
BioSafe: Pre-Fabricated Cleanroom Parts
How can Terra offer industry-leading build times and pricing? Our advanced cleanroom design doesn’t require factory pre-assembly; each component fits together perfectly, ensuring seamless on-site installation
Long Running FFU Motors
Terra’s filter fan unit motors are rated for 5 years of continuous, 24/7 operation, if the HEPA filters are consistently replaced. To accurately monitor your HEPA filter’s saturation levels, purchase Terra’s audible and visual filter replacement alarm system.
Cleanroom LED Light Panel
LED panels mount flush on ceiling grid, have longer life, and use less energy (emitting less heat) than conventional fluorescent lights.
Smooth Interior Walls
Smooth steel BioSafe cleanroom panels with radius corners simplify cleaning and stand up to biocides and disinfectants. Cleanrooms constructed with medical-grade and USP-compliant material.
Sterile Buffer Room
Swing door separates ISO 7 Buffer room from ISO 8 Anteroom; ceiling HEPA fan/filters meet USP particle and pressure differential requirements.
Biosafe Cleanroom Control Panel
Standard control panel includes centralized on/off control of lights and FFUs; displays differential pressue in the anteroom and buffer (compounding) room.
Framed Double-Flush Cleanroom Window for Pharmaceutical Compounding Rooms
Dual-pane window sits flush with wall surface, design is free of cracks and crevices where contaminants can aggregate. Design meets USP and medical-grade requirements.
BioSafe®: Terra's Ultimate Cleanliness Rating
Terra's BioSafe products are designed for the most critical applications: no gaps and crevices where microbes colonize, rounded corners for easy disinfection, won't produce contaminants during sterilization, and exceeds cGMP, IEST, ASTM and ISO 14644-1 requirements.
Cleanroom LED Light Panel with Emergency Power Supply, 2' x 2'
Cleanroom LED lights are equipped with emergency back-up batteries to ensure continued operation in the event of a power failure.
Exposure to loud noises can lower the ability to focus on work and listen selectively, which may also lead to safety issues. Typical AC units can be annoyingly loud, measuring in the range of 70 dB (comparable to a vacuum cleaner). Terra’s WhisperFlow design produces far lower noise levels for a quiet environment comparable to a library. At 90 ft/min output, units measure under 50 dB from only 1 ft away (roughly 75% quieter than 70dB).
Seismic Safe Cleanroom Design
Terra’s modular cleanrooms are designed with seismic safety in mind. Rigid steel frames and ceiling grids are designed with sufficient factors of safety to provide vertical and lateral strength recommended by professional engineers. Both hardwall and softwall designs can be installed to adhere to local seismic codes. Optional seismic and structural calculations can be drafted and stamped by a licensed PE to help meet municipal permitting requirements.
Continuous Product Improvement
At Terra, we strive to develop and produce the highest quality products for our customers to improve health, safety, performance, and yields. Our product quality is enabled by high-grade manufacturing equipment and processes, 50 years of engineering and application expertise, and our commitment to continuously improve.
4,000 Worldwide Cleanrooms
Since 1976, Terra has designed and manufactured over 4,000 cleanrooms for companies at the leading edge of high technology
Complete Order Transparency
Using Terra’s OnTrak system, our customers can view real-time production updates, receive shipment notifications and track their orders until they arrive at their facility
Comprehensive Service Provider
Terra’s portfolio of services includes white glove delivery, product installation, equipment certification, validation documentation, cleaning and disinfection services, engineering consultation, and structural seismic analysis
Products Tailored to Your Cleanroom Environment
Provide Terra with your desired ISO Grade design. We will tailor the product to meet your criteria and certify it with a report appended to your invoice. Certificate includes all the necessary information to streamline audits and facility compliance.
Popular Accessories
For a full list of accessories, select a product then click Choose Accessories on that product page.
Standard panel include pressure gauge, on/off and night switches; security system adds access restriction; automated fan system monitors and controls fan speed, pressure, temperature and RH.
BioSafe Pass-through Chambers
Pass-through chambers, available for BioSafe Cleanrooms, include interlocked doors that allow contamination-free sample transfer.
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