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USP 797 Hardwall Clean Room

usp-797 cleanroom  
Model Shown: 2900-72-PP with various options
(see Available Options for details)
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USP 797 Compounding
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Designed specifically for compounding sterile pharmaceuticals, the USP 797 hardwall cleanroom makes use of cleanroom-grade polypropylene for the wall panels, which significantly lowers the cost of the cleanroom and speeds up installation.  Transparent polycarbonate viewing window offers full visibility into the workspace and helps brighten the cleanroom environment.  These materials create smooth internal surfaces that stand up to harsh cleaning agents, including IPA, to support USP cleaning protocols.  

  • Cleanroom layout combines an ISO 8 anteroom and ISO 7 buffer room with cascading pressure levels to meet the minimum standards for sterile compounding
  • All necessary systems and components are integrated into the structure of the cleanroom, providing a turnkey USP solution
  • HEPA-filtered fan units maintain positive-pressure within the anteroom and buffer room and meet prescribed ISO particle requirements and air change rates
  • Powder-coated steel frame is fully self-supporting, requiring no external bracing or ceiling support
  • White polypropylene panels support cleaning with alcohol and other sterilizing agents
  • Pass-throughs can be added to expedite the transfer of materials and finished product, minimizing disruptions in your workflow
  • Standard configurations are available at affordable prices
  • Modular design meets any floor plan requirements; call for a custom quote!

Sterile Compounding Configuration

These turnkey sterile compounding cleanrooms include HEPA fan/filter units, LED lights, Magnehelic®gauges, external swing door, internal swing door, and 115V/60Hz duplex outlet.

 
  FEATURES & BENEFITS | USP 797 Hardwall Cleanroom
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Smooth Internal Panels
Chemically resistant polypropylene stands up to IPA and harsh sporicidal agents.
Partitioned Anteroom
Cascading positive-pressure levels from ISO 7 Buffer room to ISO 8 anteroom to the outside.
Viewing Window
Polycarbonate panel offers full visibility of the workspace and improved lighting.

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

Control Panel
Includes pressure gauges for each room; shown with optional touchscreen control console.

Adjustable Exhaust Vents
Baffled vents located at floor-level allow filtered air to escape. Easily adjust to modify room pressure.
 
  AVAILABLE OPTIONS | USP 797 Hardwall Cleanroom
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Environmental Control System
Touchscreen fan controls simplify pressure balancing; sensors monitor interior conditions
Laminar Flow Hood
Terra provides ISO 5 laminar flow benches, biosafety cabinets or compounding aseptic isolators
Cleanroom Pass-Through
Easily transfer materials and finished product without leaving the 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 797 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 797 Hardwall Cleanrooms 8-ft Ceiling Height
Overall Dimensions
Panel Type Cat. # Price
10' x 6'
(3048 x 1829mm)
Polypropylene 2900-72-PP $ 19,966
10' x 10'
(3048 x 3048mm)
Polypropylene 2900-91-PP $ 23,395
12' x 12'
(3658 x 3658mm)
Polypropylene 2900-94-PP $ 26,107
Call Terra to discuss custom sizes or configurations.

Compliance Notice

These hardwall compounding cleanrooms are designed to the requirements of USP 797 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.


Fast Cleanroom Installation While Minimizing Interruptions

The lightweight materials and modular design allow a USP 797 hardwall cleanroom to be assembled with minimal disruption of daily operations. The interlocking frame components simply slide together and lock in place. The steel beams that form the ceiling grid are predrilled for quick fastening to the frame, and the ceiling components drop right in. Wall panels are positioned in the frame openings and clamped in place with mirror-finished, ultra-smooth stainless steel brackets, which are predrilled to ensure the fast, easy installation.

Controlling Pressure Differentials

Maintaining a sterile environment for compounding requires strict control of airflow. The USP 797 hardwall cleanroom achieves this control by pressurizing each of the ISO-classified areas to different degrees. The Buffer room always has the highest pressure levels, as this is where the most critical operations take place. ISO 7-quality air from the Buffer room is pushed out into the ISO 8 Anteroom, which is only slightly pressurized. If pressure levels do not become progressively lower from room to room, this flow pattern could reverse and the lower quality air would enter the Buffer room, potentially contaminating surfaces and sensitive materials.

To control the pressure differences, Terra’s USP 797 hardwall cleanrooms include vents and baffles that adjust the amount of air exhausted from the cleanroom. The fan/filter units also have individual speed switches that can increase or decrease the amount of HEPA-filtered air that is forced into the cleanroom.

For enhanced monitoring and control, the cleanroom can be equipped with an automated monitor/control system that allows operators to adjust the speed of each FFU and balance the pressure differences, right from the control panel. This system can also be programmed to log sensor readings that provide validation of system performance, which is particularly useful when being audited by a regulatory authority.

Controlling Temperature and Humidity

Another key requirement of USP 797 is to maintain appropriate temperature and humidity levels. Fan/filter units typically draw air from the surrounding environment, but Terra Universal’s FFUs can be easily adapted to connect to the facility’s existing ductwork, allowing the cleanroom to be supplied with conditioned air.

Terra can also provide a dedicated A/C unit to be installed alongside the cleanroom, eliminating the need to modify the building’s HVAC system. These compact units are ducted into the space above the FFUs, functioning as a plenum for the conditioned air.


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

Tier II Environmental Control System

For enhanced performance and fast optimization, select Terra's Tier II Environmental Control System, which enables convenient monitoring, control and documentation of critical room pressures. These systems help you to quickly and easily bring your compounding room to target operational levels. An optional Ethernet connection furnishes the traceable history required by USP and cGMP.

System Features:

Environmental Control System Console
  • 3.5” console display for easy set-up, monitoring and control of pressure conditions in each room
  • Pressure sensors in each room
  • Individual variable control over all Fan/Filter Units to achieve target flow and pressure levels
  • Alarm outputs
  • Remote setback and shutdown capability
  • Clock-calendar control of energy-saving setback mode
  • Remote or local (SD card) data logging of environmental conditions
  • Room sensors available for temperature, relative humidity, particle counts or occupancy sensing
Cat. # Price
6702-95 $ 2,955
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