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Terra Part #Price Ships in
USP 797 (Sterile) 10' 6' 8' 304/316L SS ISO 7 2900-72-SS $29,527 25-31 Days2
USP 797 (Sterile) 10' 6' 8' uPVC ISO 7 2900-72A $22,713 45-55 Days3
USP 797 (Sterile) 10' 10' 8' 304/316L SS ISO 7 2900-92-SS $35,128 25-31 Days4
USP 797 (Sterile) 10' 10' 8' uPVC ISO 7 2900-92A $27,022 45-55 Days5
USP 797 (Sterile) 12' 10' 8' 304/316L SS ISO 7 2900-91-SS $38,638 25-31 Days6
USP 797 (Sterile) 12' 10' 8' uPVC ISO 7 2900-91A $29,721 45-55 Days7
USP 797 (Sterile) 12' 12' 8' 304/316L SS ISO 7 2900-94-SS $41,715 25-31 Days8
USP 797 (Sterile) 12' 12' 8' uPVC ISO 7 2900-94A $32,088 45-55 Days9
USP 797 (Sterile) 16' 8' 8' 304/316L SS ISO 7 2900-78-SS $39,885 25-31 Days10
USP 797 (Sterile) 16' 8' 8' uPVC ISO 7 2900-78A $30,681 45-55 Days11
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ISO Rated Air Cleanliness
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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 non-hazardous sterile compounding in compliance with USP <797> requirements
  • uPVC wall system with aluminum core will not absorb moisture or humidity, is easily cleanable, and resistant to common disinfectants
  • 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.
  • 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.
  • 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 USP 797 modular cleanroom USP 797 BioSafe Modular Cleanroom Floor Plan
  • Pharmaceutical airlocks Watch Terra's Video on Pharmaceutical Air Lock Designs
  • Portable HEPA Filtration System Watch Terra's Portable HEPA Filtration System Video
  • Cleanroom pass-through chamber with door open and entry way door USP-797 Compounding Cleanroom with Pass-Through Chamber
  • 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 USP 797 modular cleanroom
Pharmaceutical airlocks
Portable HEPA Filtration System
Cleanroom pass-through chamber with door open and entry way door
Cleanroom pass-through chamber with door open
Cleanroom pass-through chamber with door closed and entry way door closed
inside view of door on usp cleanroom
outside view of door on usp cleanroom
outside view of the cleanroom
Set of 6 Images
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!

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

Hardwall Cleanroom Partitioned Anteroom

Swing door separates ISO 7 Buffer room from ISO 8 Anteroom

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.

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.

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® 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 - 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.

BioSafe® Wall Panel System, Wall Panel Junctions Plan View

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

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.
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.
  • 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.
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Manuals & Resources
Manuals & Resources

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