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.
Combo USP 797 and 800 Cleanroom Installation for Sterile Compounding Compliance
USP 797 BioSafe Modular Cleanroom Floor Plan
Watch Terra's Video on Pharmaceutical Air Lock Designs
Watch Terra's Portable HEPA Filtration System Video
USP-797 Compounding Cleanroom with Pass-Through Chamber
Custom USP Stainless Steel BioSafe® Cleanroom for Pharmaceutical Compounding
2899-17-PP
USP Compounding Cleanroom with Polypro Wall Panels and Pass-through
This USP compounding cleanroom features smooth polypropylene wall panels that resist chemical damage and allow easy cleaning, paired with a stainless steel pass-through chamber to minimize contamination during material transfer.
Combo USP 797 and 800 Cleanroom Installation for Sterile Compounding Compliance
Two modular cleanrooms installed side by side to support USP 797 and 800 sterile compounding workflows. Each room maintains distinct environmental controls, allowing facilities to meet regulatory requirements for separate processes.
Safety Cabinet Integrated in Cleanroom for Biological Containment
Installed in a cleanroom, this safety cabinet maintains cleanliness and containment through filtered airflow, enabling safe handling of sensitive biological materials.
Cleanroom Interior with Safety Cabinet and Stainless Steel Pass-Through
This cleanroom interior features a safety cabinet for personnel and product protection, along with a stainless steel pass-through chamber to maintain sterility during material transfers in USP compounding environments.
Cleanroom Area with Pass-Through, Sink and Environmental Control Panel
As part of the cleanroom, the pass-through, stainless steel sink, and control panel work together to support sterile material handling and maintain environmental controls.
Modular Cleanroom System Installs Easily Within Existing Workspaces
This modular cleanroom system is engineered for seamless integration into existing facilities. Its prefabricated design allows for flexible installation in a variety of workspaces while maintaining cleanroom performance standards.
Modular turnkey cleanroom with USP 797 compliance features positive pressure buffer and ante-rooms of cascading pressure, ensuring an isolated compounding environment supplied with only HEPA-filtered air.
The layout of the USP 797 non-hazardous compounding cleanrooms with positive pressure ante-room and buffer room | 2900-PP-06 displayedUSP 797 BioSafe Modular Cleanroom Floor PlanModular turnkey cleanroom with USP 797 compliance features positive pressure buffer and ante-rooms of cascading pressure, ensuring an isolated compounding environment supplied with only HEPA-filtered air.
Airlocks safeguard cleanrooms, preventing cross contamination during transfersWatch Terra's Video on Pharmaceutical Air Lock DesignsAirlocks 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.
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 VideoThe 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.
USP-797 Compounding Cleanroom with Pass-Through Chamber
Make the transferring of materials from one room to another easy, by utilizing pass through chambers and secure entry ways. Built for user comfort and mobility.
USP-797 Compounding Cleanroom with Pass-Through Chamber
Reduce contamination and cross-traffic by using a cleanroom pass-through to transfer materials and equipment between rooms. It is a vital component for ensuring material integrity during handling, allwoing for unnecessary personnel movement.
USP-797 Compounding Cleanroom with Pass-Through Chamber
Secure entry way helps prevent contamination by creating an airtight seal. This seal helps maintain the required pressure differential and blocks airborne particles from entering.
USP-797 Compounding Cleanroom for Sterile Pharmaceutical Preparations
Security begins at the entrance. This self-contained USP 797 cleanroom features a secure entry system to protect its highly sterile environment, along with seamless wall panels to ensure complete contamination control.
USP-797 Compounding Cleanroom for Sterile Pharmaceutical Preparations
Experience optimal contamination control with the USP-797 compounding cleanroom' seamless wall panels for a highly sterile compounding environment. Its durable, easy-to-clean surfaces support sterile pharmaceutical compounding operations while meeting regulatory requirements.
USP-797 Compounding Cleanroom for Sterile Pharmaceutical Preparations
For safe and compliant sterile compounding, this modular cleanroom uses integrated HEPA filtration to maintain precise, ISO-classified air quality. The seamless build eliminates contamination risks.
Custom USP Stainless Steel BioSafe® Cleanroom for Pharmaceutical Compounding
This image captures the outer transition area to a cleanroom, equipped with secure stainless steel doors, environmental monitoring systems, and keycard access. The cleanroom's glass windows offer a view into the sterile environment beyond
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
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
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.
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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