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
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 sterile compounding in compliance with USP <800> requirements
BioSafe® modular wall panel system features coved corners between the ceilings, walls, and floors to maintain a flush finish
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 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.
Simplify Cleanroom Construction with BioSafe® Wall Panel System
Custom USP Stainless Steel BioSafe® Cleanroom for Pharmaceutical Compounding
BioSafe Modular Cleanroom with Integrated Gowning Anteroom
Combo USP 797 and 800 Cleanroom Installation for Sterile Compounding Compliance
USP 797 Compounding Cleanroom with ULPA Filtered Passthrough
Multi-Suite USP 797 and 800 Pharmaceutical Compounding Cleanroom
USP 800 Compounding Cleanroom
USP 797 BioSafe Stainless Steel Clean Room
USP 797 Hardwall Cleanroom
USP 800 BioSafe Cleanroom for Hazardous Drug Compounding
USP 800 BioSafe Cleanroom, Stainless Steel
Custom USP 797 BioSafe Cleanroom
USP-797 Compounding Cleanroom with Pass-Through Chamber
Watch Terra's Video on Pharmaceutical Air Lock Designs
USP-795 Compounding Cleanroom
BioSafe® Wall Panel System cGMP compliant, 304 and 316 stainless steel or pre-coated uPVC steelSimplify Cleanroom Construction with BioSafe® Wall Panel SystemBuild faster and cleaner with Terra Universal’s BioSafe® Wall Panel System. Ideal for ISO Class 4 and cGMP facilities, the seamless monolithic design ensures superior cleanliness and durability.
These modular panels simplify installation, reduce costs, and allow quick reconfiguration.
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
BioSafe Modular Cleanroom with Integrated Gowning Anteroom
This ISO 5 certified BioSafe cleanroom features monolithic wall panel connections without gaps or ledges, ensuring compliance with ISO-14644, cGMP, and GLP requirements.
The turnkey UL-listed design streamlines building permitting while the flush-mount wall panel system eliminates particle-trapping gaps found in traditional panel-post construction.
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.
USP 797 Compounding Cleanroom with ULPA Filtered Passthrough
This central fill compounding cleanroom consists of three staged rooms. ULPA filtered Passthrough chambers allow supplies and materials to be passed from room to room
Ante chambers maintain the integretyy of the cleanroom while allowing users to recive supplies and materials, don further cleanroom attire or conduct prep work
USP 797 BioSafe Clean Room includes ISO 8 ante-room and ISO 7 buffer roomUSP 797 BioSafe Stainless Steel Clean RoomUSP 797 BioSafe Clean Room includes ISO 8 ante-room and ISO 7 buffer room (floor not included); shown with optional hand cleaner, biosafety cabinet.
8658
USP 797 Hardwall Cleanroom
USP 797 BioSafe Clean Room includes ISO 8 ante-room and ISO 7 buffer room (floor not included); shown with optional hand cleaner, laminar flow hood.
USP 797 BioSafe Clean Room includes ISO 8 ante-room and ISO 7 buffer roomUSP 797 Hardwall CleanroomUSP 797 BioSafe Clean Room includes ISO 8 ante-room and ISO 7 buffer room (floor not included); shown with optional hand cleaner, laminar flow hood.
USP 800 BioSafe Cleanroom for bio-hazard containment | 2899-06-SS displayedUSP 800 BioSafe Cleanroom for Hazardous Drug CompoundingUSP 800 BioSafe Cleanroom for bio-hazard containment includes ISO 8 ante-room, ISO 7 buffer room; optional hand cleaner, biosafety cabinet, flooring.
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USP 800 BioSafe Cleanroom, Stainless Steel
USP 800 BioSafe cleanroom with ISO 8 ante-room, ISO 5 compounding suites and negative-pressure containment suite, surrounded by a standard hardwall cleanroom frame for enhanced biohazard containment
USP 800 BioSafe cleanroom with ISO 8 ante-room, ISO 5 compounding and containment suitesUSP 800 BioSafe Cleanroom, Stainless SteelUSP 800 BioSafe cleanroom with ISO 8 ante-room, ISO 5 compounding suites and negative-pressure containment suite, surrounded by a standard hardwall cleanroom frame for enhanced biohazard containment
10021
Custom USP 797 BioSafe Cleanroom
BioSafe cleanrooms blend in with facility construction and can tie to existing A/C and other utilities.
BioSafe cleanrooms blend in with facility constructionCustom USP 797 BioSafe CleanroomBioSafe cleanrooms blend in with facility construction and can tie to existing A/C and other utilities.
2900-78-PP
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.
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.
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.
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
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.
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.
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.
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.
Seamless design is compliant with ISO-14644, cGMP, GLP, ASTM and IEST requirements. 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.
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
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