USP 797 BioSafe Clean Room includes ISO 8 ante-room and ISO 7 buffer room

USP 797 Hardwall Cleanrooms

Available ISO Rated Designs: ISO 5, ISO 6, ISO 7, ISO 8

Manufactured By: Terra Universal

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Select Product Options

Application	Certified ISO Grade™ Design	ISO Rated™ Air Cleanliness	Frame Material	Width	Depth	Height	Panel Material	Price	Usually Ships in
USP 797 (Sterile)	ISO 5	ISO 5	Powder-Coated Steel	10'	6'	8'	Polypropylene	$23,586	15-21 Days
USP 797 (Sterile)	ISO 5	ISO 5	Powder-Coated Steel	10'	10'	8'	Polypropylene	$28,060	15-21 Days
USP 797 (Sterile)	ISO 5	ISO 5	Powder-Coated Steel	12'	10'	8'	Polypropylene	$30,863	15-21 Days
USP 797 (Sterile)	ISO 5	ISO 5	Powder-Coated Steel	12'	12'	8'	Polypropylene	$33,321	15-21 Days
USP 797 (Sterile)	ISO 5	ISO 5	Powder-Coated Steel	16'	8'	8'	Polypropylene	$31,860	15-21 Days

Summary

Available ISO Rated Designs: ISO 5, ISO 6, ISO 7, ISO 8

Designed for compounding sterile preparations to the requirements of USP 797

Cleanroom-grade polypropylene wall panels stand up to frequent sterilization

Low-cost compounding cleanroom with easy installation

Transparent polycarbonate viewing window for light and visibility of work inside

Customer can choose between two sensors for monitoring cleanroom pressure and temperature

Verify before you buy: Consultation services available to ensure evaluate compliance with USP, cGMP, DQSA and other regulations

Combines ISO 7 anteroom and ISO 5 buffer room with cascading pressure levels

Anteroom can be used for gowning or other prep

Heavy-duty steel ceiling grid securely holds HEPA-filtered fan units and LED light panels

Positive-pressure anteroom and buffer room meet prescribed ISO particle requirements and air change rates

Add optional pass-through chambers for transferring materials and finished products between rooms

Modular design meets any floor plan requirements; call for a custom quote!

Specifications

• Marks & Listings: UL, ULC

Watch Terra's Portable HEPA Filtration System Video
Watch Terra's Video on Pharmaceutical Air Lock Designs

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 Video The 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.

Airlocks safeguard cleanrooms, preventing cross contamination during transfers Watch Terra's Video on Pharmaceutical Air Lock Designs Airlocks are a crucial part of protecting your cleanroom from contamination while maintaining the required ISO rating. By preserving pressure differentials between adjoining rooms, air locks prevent cross contamination when personnel, materials and samples are transferred between contiguous spaces. The pressure cascade created from the gowning room to the personnel air lock to the ISO-rated cleanroom acts as a safeguard against the accidental influx of particles, dust and microbial contaminants.

Features and Benefits

Critical Environment Solutions

Terra's mission is to help customers in highly regulated industries transform the world with critical environment solutions that improve health, safety, performance, and yields. These environments may comply with stringent UL, ISO, IEST, ASTM and OSHA standards and local requirements.

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.

In Stock Pre-Fabricated Cleanroom Components

Since each pre-fabricated cleanroom component is tested and stocked, room pre-assembly is no longer required. Our lead times consist solely of the time it takes draw, package and ship the components to you.

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.

Hardwall Cleanroom Chemical-Resistant Panels

Chemically resistant polypropylene, mounted in mirror-finish steel brakets

Hardwall Cleanroom Partitioned Anteroom

Swing door separates ISO 7 Buffer room from ISO 8 Anteroom

Viewing Window for Modular Cleanroom

Cleanroom viewing windows provide ambient light and offer full visibility of the workspace. Polycarbonate offers chemical resistance, plus the highest durability (250x the impact resistance of glass). Static-Dissipative PVC panels are also chemical resistant and dissipate static charge to prevent particles from clinging to the window.

LED Lights, Fan Filter Units

HEPA fan/filter units (FFUs) exceed ISO 7 requirements for compounding buffer room; energy-efficient LED lights minimize generated heat

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.

Adjustable Exhaust Vents

Adjustable IsoVents help control internal pressure to meet ISO regulations and maintain cascading pressure differentials.

Clean and Durable Powder Coat Finish

Terra’s signature white powder coat finish provides a high quality, durable barrier to protect against corrosion, plus a clean and attractive aesthetic. The advanced heat-fused formulation exceeds ASTM and ISO paint standards to resist chipping, scratching, fading, and wearing.

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.

WhisperFlow Quiet Operation Reduces Distracting Background Noise

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.

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.

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Lighthouse Handheld Airborne Particle Counters

Lightouse portfolio of handheld airborne particle counters ensure accurate readings of cleanrooms and critical environments
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Germicidal UV Lamp Sanitizes Labs, Cleanrooms

UV-C Germicidal Lamp installs on a cleanroom ceiling grid for line-of-sight room disinfection; safety occupancy sensor prevents personnel exposure.
Available Environmental Control System

Standard cleanroom comes with analog pressure gauge and on/off controls; optional touchscreen FFU controller monitors, controls and logs internal pressure, as well as displaying temperature and RH.
Bootie Butler Shoe Cover Dispenser

Bootie butler shoe cover dispenser applies shoe covers quickly and conveniently, reinforcing clean garbing protocol and keeping contaminants out of the cleanroom
ISO 5 Laminar Flow Hood

Laminar flow hood provides the ISO 5 Primary Engineering Control (PEC) stipulated in USP-797 for sterile compounding of non-hazardous preparations.
Hardwall Cleanroom Cleanroom Pass-Through

Easily transfer materials and finished product without leaving the cleanroom
Glove and Garb Dispensers

Wall-mounted cleanroom garb and glove dispensers save ante-room space and promote clean garbing protocol.
Biosafe Cleanroom Hands-Free Sink

Hands-free sink and hand dryer, seen in cleanroom anteroom, boost compliance with hand-washing protocol.