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USP 800 Hardwall Clean Room
For Hazardous Drug Compounding

usp-797 cleanroom
Model Shown: 2899-10-PP with various options
(see Available Options for details)
See all of Terra's
products used for
USP 797/800 Compounding
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See Below

These low-cost cleanrooms, based on the design of the USP 797 Hardwall cleanroom, are configured for compounding hazardous formulations specified on the NIOSH hazardous drug list. In addition to protecting the sterile product from contamination, a negative-pressure cleanroom protects personnel from exposure to airborne hazards.  

  • Negative-pressure, ISO 7 Buffer room protects personnel by ventilating the cleanroom through a designated exhaust system; contaminated air is never recirculated
  • Integrated anteroom with ISO 7 air quality avoids cross-contamination of the Buffer room
  • Tier II Environmental Control System (standard on USP 800 cleanrooms) allows enhanced control of FFUs, simplifies pressure balancing, and provides a traceable environmental history
  • Smooth, durable, chemical-resistant polymers ensure the wall panels hold up against frequent cleaning
  • Seams and ceiling panels in the Buffer room can be sealed with silicone caulking to create an air-tight space for compounding sterile HDs
  • Standard configurations are available at affordable prices (see ordering chart below)
  • Modular hardwall cleanrooms can be designed to fit in any facility; call for a custom quote!

Sterile HD Compounding Configuration

These turnkey sterile compounding cleanrooms include: HEPA fan/filter units, LED lights, Magnehelic®gauges, Tier II Environmental Control System, exhaust plenum, external swing door, internal swing door, and 115V/60Hz duplex outlet.

 
  FEATURES & BENEFITS | USP 800 Hardwall Cleanroom
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Environmental Control System
Touchscreen fan controls simplify pressure balancing; sensors monitor interior conditions
Partitioned Anteroom
Negative-pressure Buffer room is isolated by an ISO 7 positive-pressure Anteroom.
Exhaust Containment Plenum
Connects to an existing exhaust fan system to remove air from the buffer room

Smooth Internal Panels
Chemically resistant polypropylene stands up to IPA and decontamination agents.

LED Lights and Filter/Fan Units
FFUs shower the room in HEPA-filtered air; energy-efficient LED lights minimize generated heat.

Viewing Window
Polycarbonate panel offers full visibility of the workspace and improved lighting.
 
  AVAILABLE OPTIONS | USP 800 Hardwall Cleanroom

Glove/Garb Dispenser
Wall-mounted cleanroom garb dispensers save space in the anteroom

Bootie Butler
Fast, automated donning of shoe-coverings to reduce cleanroom contaminants

Hands-Free Sink
Hands-free sink and hand dryer in the anteroom help comply with hand-washing protocol

Standard USP 800 Hardwall Cleanroom Layout
 
USP 797 Cleanroom Standard Configuration Diagram

Does not include floors; the cleanrooms are designed for installation
on a flat, sealed, non-particulating, crevice-free surface.

 
USP 800 Hardwall Clean Rooms 8-ft Ceiling Height
Overall Dimensions
Panel Type Cat. # Price
10' x 6' 
(3048 x 1829mm)
Polypropylene 2899-10-PP $ 28,551
12' x 10'
(3048 x 3048mm)
Polypropylene 2899-04-PP $ 33,871
12' x 12'
(3658 x 3658mm)
Polypropylene 2899-06-PP $ 35,331
Call Terra to discuss custom sizes or configurations.

Compliance Notice

These BioSafe® compounding cleanrooms are designed to the requirements of USP 797 and USP 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 with our compounding experts to evaluate suitable for your application.


Negative-Pressure HD Storage Rooms

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.


Terra Universal's Environmental Control System
All USP 800 cleanrooms include a Tier II Environmental Control System, allowing compounding pharmacists to optimize their cleanroom for efficient operating conditions. These systems enable automatic monitoring, fine adjustments, and traceable documentation to streamline certification and regulatory audits (such as FDA inspections).
  • 3.5” touchscreen console display for easy set-up and monitoring of conditions in each room
  • Ethernet connection for logging and storing room pressures or other data
  • Pressure sensors in each room
  • Individual variable control over all Fan/Filter Units to achieve target flow and pressure levels
  • Fan performance and room pressure warning alerts via Ethernet
  • Remote setback and shutdown capability
  • Clock-calendar control of energy-saving setback mode
aircare_acc7015_console

Declaration of UL Listing

Separately order a declaration of system listing under UL File E472687, including all high-voltage Modular Cleanroom electrical components integrated into Power Distribution System (Terra Nos. 6600-29B-P, 6600-29B-S, 6600-29B-B, 6600-29B-P-220, 6600-29B-S-220, 6600-29B-S-220, 6600-27, 6600-27-220). UL listing helps meet municipal and other permitting requirements that may apply.

Cat. # Price
6600-33 Call TUI
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