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Terra Part # Price Ships in
USP 800 (Sterile HD) Stainless Steel 10' 6' 8' 304 Stainless Steel ISO 5 2899-10-SS 69185 $53,132 25-31 Days 2
USP 800 (Sterile HD) Stainless Steel 10' 10' 8' 304 Stainless Steel ISO 5 2899-17-SS 75626 $63,476 25-31 Days 3
USP 800 (Sterile HD) Stainless Steel 12' 10' 8' 304 Stainless Steel ISO 5 2899-04-SS 64784 $68,391 25-31 Days 4
USP 800 (Sterile HD) Stainless Steel 12' 12' 8' 304 Stainless Steel ISO 5 2899-06-SS 64785 $73,812 25-31 Days 5
USP 800 (Sterile HD) Stainless Steel 16' 8' 8' 304 Stainless Steel ISO 5 2899-16-SS 75617 $70,400 25-31 Days 6
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Request demo from your product specialist or add note to your order or quote request.

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Custom-configured product. Contact Terra by phone, chat or email for a project-specific quote.
Custom-configured product. Contact Terra by phone, chat or email for a project-specific quote.
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Product Details
Product Details
  • Available ISO Ratings: ISO 5, ISO 6, ISO 7, ISO 8
  • 304-grade stainless steel construction is resistant to corrosion, stands up to disinfectants
  • Will not produce contaminants during sterilization
  • Reduces bio-burden in compounding spaces
  • Free-standing 304 stainless steel structure meets the requirements of USP 800 for negative-pressure containment in hazardous-drug compounding
  • Includes exhaust plenum with flanges for connection to the customer-furnished ventilation system capable of drawing out air introduced by the fan/filter units
  • Standard layout features a negative-pressure Buffer room (ISO 7 or 5, depending on requirement) and a positive-pressure ISO 7 Anteroom
  • Meets USP compliance with Environmental Control System, which monitors room pressures, temperature, and humidity; includes two sensors, and customer can choose between two versions
  • Stainless steel double-wall insulated panels with covered corners product a smooth, easy-clean interior; allow flush-mounting of power outlets
  • Exceeds USP cleanliness and aseptic requirements
  • Wall structure bolts together and panels snap in place, simplifying installation
  • Verify before you buy: Consultation services available to ensure evaluate compliance with USP, cGMP, DQSA and other regulations
  • Wall panels can be sealed with silicone caulking to eliminate all cracks and simplify disinfection
  • Heavy-duty steel ceiling grid is fully supported by the wall structure; holds HEPA-filtered fan units and LED light panels without need for external bracing
  • Specialized pass-throughs can be included for transfer of finished products, minimizing disruptions in your workflow
  • Features available for logging and storing room pressures and temperature
  • Pressure sensor included in each room
  • Clock-calendar control of energy-saving setback mode
  • Standard configurations are available at affordable prices, or specify custom sizes to fit unique facility requirements; call for a custom quote!
  • Standard turnkey configurations include RSR HEPA fan/filter units, LED light panels, duplex outlets, ante-/buffer room panels and ceiling grid; installed on site
  • These BioSafeĀ® compounding cleanrooms are designed to the requirements 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 with our compounding experts to evaluate suitability for your application

ā€¢ Marks & Listings: UL, ULC

USP Compounding Cleanrooms

  • Portable HEPA Filtration System Watch Terra's Portable HEPA Filtration System Video
  • Pharmaceutical airlocks Watch Terra's Video on Pharmaceutical Air Lock Designs
Portable HEPA Filtration System
Pharmaceutical airlocks
Features & Benefits

Features and Benefits

Learn More: Hazardous Drug Storage

Negative-Pressure HD Storage Rooms

The layout of the USP 800 Hardwall cleanroom can be modified to include a negative-pressure storage room adjacent to the Buffer room. A dedicated HD storage room provides a convenient, USP 800-compliant receiving/unpacking area for HD shipments that does not require cleanroom garb. ISO classification is not required for HD storage rooms; air must simply be exhausted at a rate of 12 air changes per hour (ACPH). The storage room exhaust can often be integrated with the Buffer room exhaust for maximum efficiency.

USP 800 also cautions against placing HD refrigerators in the Buffer room, as the refrigerators tend to harbor contaminants and release significant numbers of particles. The designated HD refrigerator can instead be placed inside the HD storage room.

Adding a HEPA-filtered pass-through in the HD storage room allows operators to easily transfer the HD bag into the cleanroom for manipulation. Prior to compounding, operators can pull the necessary items from storage and place them in the pass-through chamber. The HD ingredients can remain in the pass-through, ready for receipt, until the compounder has gone through gowning and finished all other preparations. Following compounding, the final HD product can be safely transferred back into the HD storage room.

Non-Sterile HD Compounding

According to USP 800, non-sterile HD compounding must also take place within a negative-pressure room that is physically separated from other areas. An exhaust system (directed to the outside of the building) must be used to ventilate the contaminated air and create a slight vacuum (negative-pressure).

The key difference for non-sterile HD compounding is that it does not require HEPA filtered airflow, which can significantly reduce the cost and complexity of building a containment room. Existing HVAC systems can provide fresh air to replace the air removed by the exhaust system.

Because HD contamination can be difficult to clean, non-sterile HD compounding rooms share the same construction features with sterile compounding cleanrooms. Surfaces must be smooth, made of non-shedding materials, and minimize crevices where contamination can collect.

Please contact Terra Universal for quotes regarding USP 800 cleanrooms without the HEPA-filtered FFUs.

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.

BioSafe: Pre-Fabricated Cleanroom Parts

How can Terra offer industry-leading build times and pricing? Our advanced cleanroom design doesnā€™t require factory pre-assembly; each component fits together perfectly, ensuring seamless on-site installation

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.

Containment Exhaust Plenum

Negative-pressure containment cleanrooms include exhaust plenums that route air to floor- or ceiling-mount fans, protecting the external environment from hazardous materials inside the cleanroom.

BioSafeĀ®: 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.

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.

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.

Flush-Mount Dual Pane Windows

Flush mount dual-pane window design simplifies cleaning.

Stainless Steel Cleanroom Door

Stainless steel doors provide resistance to chemicals and minimize surface particle shedding. Choose 316L stainless steel as an optional substitute material.

Seismic Safe Cleanroom Design

Terraā€™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 Terraā€™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

Terraā€™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.
Available Accessories
Popular Accessories
For a full list of accessories, select a product then click Choose Accessories on that product page.
  • Lighthouse Handheld Airborne Particle Counters

    Lightouse portfolio of handheld airborne particle counters ensure accurate readings of cleanrooms and critical environments
  • 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.
  • Biosafe Cleanroom Laminar Flow Hood

    Terra provides ISO 5 laminar flow benches, biosafety cabinets or compounding aseptic isolators.
  • BioSafe Pass-through Chambers

    Pass-through chambers, available for BioSafe Cleanrooms, include interlocked doors that allow contamination-free sample transfer.
  • Biosafe Cleanroom Hands-Free Sink

    Hands-free sink and hand dryer, seen in cleanroom anteroom, boost compliance with hand-washing protocol.
  • Space-Efficient Glove and Garb Dispensers

    Wall-mounted cleanroom garb and glove dispensers save ante-room space and promote clean garbing protocol.
  • 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
  • Cleanroom Biosafe Mirror

    Cleanroom Biosafe mirror minimizes cracks where germs collect, helps guarantee correct garbing protocol (frameless design shows).
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Manuals & Resources
Manuals & Resources

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