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Summary

  • Available Certified ISO Grade Designs: ISO 5, ISO 6, ISO 7, ISO 8
  • Containment Room Dimensions: 6' W x 10' D x 8' H (1828 x 3048 x 2438mm)
  • Ante-room Dimensions: 4' W x 10' D x 8' H (1219 x 3048 x 2438mm)
  • BioSafe® modular wall panel system features coved corners between the ceilings, walls, and floors to maintain a flush finish
  • All gaps are filled by an FDA-grade silicone sealant to ensure a leak-tight system to prevent contamination influx
  • uPVC wall system with aluminum core will not absorb moisture or humidity, is easily cleanable, and resistant to common disinfectants
  • 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 10' D x 8' H (1219 x 3048 x 2438mm)
  • ISO 5 USP 800 negative-pressure hazardous compounding room. 6' W x 10' D x 8' H (1828 x 3048 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.
  • 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.
  • See accessories to choose compliant biosafety cabinet

Specifications

Application: USP 800 (Sterile HD)

Height: 8'

Depth: 10'

Width: 10'

Overall Dimensions: 10' x 10' x 8'

Panel Material: uPVC

Cleanroom Type: Wall System

Unit of Measure: EA

Marks & Listings: UL, ULC

Electrical Specifications: 120 V, 50 A, 1 Ph, 60 Hz

Weight, Shipping: 1,450 lb

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.

Energy Efficient LED Light Panel

Energy-efficient LED lighting cuts power consumption without sacrificing brightness. Built for long service life with minimal maintenance in controlled environments.

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.

Negative-Pressure Buffer Room

Negative-pressure ISO 5 or 7 Buffer room contains hazardous substances to protect the external environment, in accord with USP-800 requirements.

Exhaust Containment Plenum

Exhaust plenums route potentially hazardous air from cleanroom vents directly to mounted fans in a fully enclosed pathway. Purpose-built containment design ensures outward environmental protection meets safety and compliance requirements.

BioSafe® Wall Panel System, Wall Panel Vertical Joint Detail

Fully monolithic and seamless connecting wall panel system (not a panel-post system with gaps and ledges).

BioSafe® Wall Panel System, Wall Panel Junctions Plan View

Seamless coved transitions between ceiling, walls, and floors allow for easy cleaning.

BioSafe® Wall Panel System, Wall Panel - Ceiling Panel Junction

Seamless design is compliant with ISO-14644, cGMP, GLP, ASTM and IEST requirements. Coved transitions between ceiling, walls, and floors allow for easy cleaning.

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.

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

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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    Hands-free sink and hand dryer prevents further contamination
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