Containment Room Dimensions: 8' W x 10' D x 8' H (2438 x 3048 x 2438mm)
Ante-room Dimensions: 4' W x 10' D x 8' H (1219 x 3048 x 2438mm)
Specified internal height is 8' (2438 mm) from the floor to filter face. FFUs add 15" (381 mm) overhead clearance to this measurement. To assure 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)
Materials: Double-wall, insulated 304 Stainless Steel panels with radius corners provide clean, ISO 5-compatible interior surfaces that are easy to clean and sterilize
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
No floor 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
Air exhaust vents are adjustable to allow pressure balancing
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 797 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
(4) 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
(2) Pressure, temperature, and RH sensors
FDA-approved silicone sealant for caulking internal seams
Specifications
• Application: USP 797 (Sterile)
• Frame Material: Stainless Steel
• Height: 8'
• Depth: 10'
• Width: 12'
• Overall Dimensions: 12' x 10' x 8'
• Panel Material: 304 Stainless Steel
• Unit of Measure: EA
Helena
• Marks & Listings: UL, ULC
• Electrical Specifications: 120 V, 1 Ph, 60 Hz
• Weight, Shipping: 1,250 lb
USP Compounding Cleanrooms
Watch Terra's Portable HEPA Filtration System Video
Terra's in stock portable HEPA filtration systems provide high quality and medical grade air filtration for your ambient environment.Watch Terra's Portable HEPA Filtration System VideoThe mobile/ self contained filtration system converts to any room to a negative pressure isolation room which then makes it well suited for medical clinics, schools, waiting rooms and other confined areas.
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, 45 years of engineering and application expertise, and our commitment to continuously improve.
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 Compliant With Your ISO Rating
Provide Terra with your desired ISO rating. We will tailor the product to meet your rating and supply a certificate of compliance appended to your invoice, to be included in your compliance package. All certificates are archived in Terra's system for quick retrieval.
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.