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Terra Part #Price Ships in
USP 797/800 Combo 26' 8' 8' 304/316L SS ISO 7 ISO 4 2899-23-SS $68,290 45-55 Days2
USP 797/800 Combo 26' 8' 8' uPVC ISO 7 ISO 5 2899-23 $52,531 45-55 Days3
USP 797/800 Combo 16' 6' 8' 304/316L SS ISO 7 ISO 4 2899-22-SS $50,719 45-55 Days4
USP 797/800 Combo 16' 6' 8' uPVC ISO 7 ISO 5 2899-22 $39,014 45-55 Days5
USP 797/800 Combo 16' 10' 8' uPVC ISO 7 ISO 5 2899-24 $45,909 45-55 Days6
USP 797/800 Combo 18' 10' 8' 304/316L SS ISO 7 ISO 4 2899-24-SS $59,682 45-55 Days7
USP 797/800 Combo 20' 10' 8' 304/316L SS ISO 7 ISO 4 2899-20-SS $67,868 45-55 Days8
USP 797/800 Combo 20' 10' 8' uPVC ISO 7 ISO 5 2899-20 $52,206 45-55 Days9
USP 797/800 Combo 20' 12' 8' 304/316L SS ISO 7 ISO 4 2899-21-SS $73,000 45-55 Days10
USP 797/800 Combo 20' 12' 8' uPVC ISO 7 ISO 5 2899-21 $56,154 45-55 Days11
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ISO Rated Air Cleanliness
Certified ISO Grade Cleanroom Design
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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 Certified ISO Grade Designs: ISO 5, ISO 6, ISO 7, ISO 8
  • Free-standing, fully-integrated turnkey pharmacy compounding cleanroom system with all major components included
  • •  Designed for hazardous and non-hazardous sterile compounding in compliance with USP <797> and <800> requirements
  • Series of positive and negative pressure rooms ensure both sterile and hazardous compounding rooms maintain USP standards
  • Environmental Control System with touchscreen interface monitors and logs temperature, pressure, and humidity in compliance with USP standards
  • BioSafe® wall and ceiling panel system combines high durability with exceptionally smooth surfaces and coved corners for easy sterilization
  • 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.
  • ISO 5 USP 797 positive-pressure sterile compounding room.
  • ISO 5 USP 800 negative-pressure hazardous compounding room.
  • 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.

Marks & Listings: UL, ULC

USP Compounding Cleanrooms

  • Two cleanrooms side by side for USP 797 and 800 compounding compliance Combo USP 797 and 800 Cleanroom Installation for Sterile Compounding Compliance
  • diagram displaying the layout of the combination USP 797/800 modular cleanroom Combination USP 797 and 800 BioSafe Modular Cleanroom Floor Plan
  • Pharmaceutical airlocks Watch Terra's Video on Pharmaceutical Air Lock Designs
  • Cleanroom gowning or entry vestibule with stainless steel doors Custom USP Stainless Steel BioSafe® Cleanroom for Pharmaceutical Compounding
USP cleanroom with polypropylene panels and stainless steel pass-through
ValuLine stainless steel foot-pedal sink in USP compounding cleanroom
stainless steel work station with mounted universal hood in USP compounding cleanroom
Two cleanrooms side by side for USP 797 and 800 compounding compliance
Safety cabinet inside cleanroom providing containment for biological work
Cleanroom interior with safety cabinet and stainless steel pass-through chamber
Cleanroom with pass-through, stainless steel sink, and system control panel
Modular cleanroom interior designed to fit into existing workspace environments
Set of 8 Images
diagram displaying the layout of the combination USP 797/800 modular cleanroom
Pharmaceutical airlocks
Cleanroom gowning or entry vestibule with stainless steel doors
Cleanroom interior with stainless steel walls, sink, and workstation
Cleanroom with stainless steel sliding door and observation window
Cleanroom pass-through chamber with glass door open
Cleanroom pass-through chamber with gloves and medical refrigerator
Hazardous cleanroom with isolator for sterile compounding
Cleanroom gowning and transition area with bench seating
Cleanroom entry door with window and electronic control panel
Set of 8 Images
Features & Benefits

Features and Benefits

Learn More: USP-Compliant Cleanrooms
USP 800 BioSafe Cleanroom, Custom Floor Plan

Affordable customization to unique requirements!

  • Terra’s modular designs allow versatile configurations using standard components, whether you need a small compounding enclosure or a multi-suite processing facility (shown: Stainless steel USP 800 multi-room hazardous materials cleanroom with plastic hardwall ISO 8 transition room)
  • Versatile plug-and-play Power Distribution Modules allow addition of ceiling fan/filter units and lights to meet any cleanliness requirement or to upgrade ISO levels or lighting levels after installation
  • Modular frame and panel designs, in several application-specific materials, adapt to any floor plan requirement
  • Automated fan controls simplify pressure balancing, Building Management System (BMS) integration, and certification of large, multi-suite facilities
  • Stand-alone A/C modules or integration with existing air handling system
  • Negative-pressure plenums and exhaust fans accommodate hazardous materials compounding requirements (USP 800)
  • Consultation services available to meet USP 797 and 800 and FDA/cGMP requirements
  • Terra’s full engineering services adapt designs to accommodate unique equipment or facility integration challenges

Call or submit a QuickQuote Form for assistance with a modular cleanroom tailor-made to your application!

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

Exhaust Containment Plenum

Containment design includes exhaust plenums that route air from vents inside the enclosure to floor- or ceiling-mount fans, protecting the external environment from hazardous materials inside the cleanroom.

Combination USP 797 and 800 BioSafe Modular Cleanroom Floor Plan

The pressure differentials in the turnkey BioSafe Modular USP 797/800 compounding cleanrooms are configured to cascade from high pressure to low pressure to ensure compliant airflow in both chambers.

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.
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.
  • 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
  • Glove and Garb Dispensers

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

    Hands-free sink and hand dryer prevents further contamination
Products similar to this one
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Manuals & Resources
Manuals & Resources

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