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USP 797 BioSafe® Clean Room

 
usp-797 cleanroom
Model shown: No. 2900-72-SS  
(shown with optional PureDry Hand Washer/Dryer and Labconco RXPert Double-Filtered Hood)
 
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USP 797 Compounding
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Constructed almost entirely of stainless steel, the USP 797 BioSafe Cleanroom combines high durability with exceptionally smooth interior surfaces to meet the most stringent cleanliness requirements. Modeled after the facilities found in other cGMP industries, the BioSafe line of pharmacy cleanrooms features insulated wall panels and radius corners for frequent sterilization and decontamination.  

  • ISO 7 Buffer room, physically separated from the ISO 8 anteroom and protected by cascading positive-pressure levels as specified in USP 797
  • 304 stainless steel wall panels stand up to daily cleaning with a wide variety of chemicals, including IPA
  • Wall structure bolts together and panels snap in place, simplifying installation
  • Gaskets installed between the wall panels minimize leaks and seams can be sealed with silicone caulking for even smoother surfaces
  • Internal partition with two-way swing door allows for gowning and hand-washing prior to entering the Buffer room
  • Heavy-duty steel ceiling grid is fully supported by the wall structure and can hold a number of HEPA-filtered fan units and LED light panels
  • Specialized pass-throughs can be included to expedite the transfer of materials and finished product, minimizing disruptions in your workflow
  • Exterior wall panels can be powder-coated white for aesthetic purposes
  • Standard configurations are available at affordable prices (see ordering chart below)
  • 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, tempered-glass viewing window, and 115V/60Hz duplex outlet.

 
  FEATURES & BENEFITS | USP 797 BioSafe Cleanroom
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Stainless Steel Panels
Smooth, durable 304 stainless steel walls hold up against IPA and other cleaning agents
Partitioned Anteroom
ISO 7 Buffer room is entered through the ISO 8 Anteroom, physically separated by a two-way swing door
Viewing Window
Dual-pane, polycarbonate window is flush with the wall surface and provides a full view of the compounding operation

LED Light Panels
Energy-efficient LED lights provide bright lighting without generating excessive heat

Control Panel
Includes pressure gauges for each room, as well as a Night mode key-switch for lower power consumption when not in use

Adjustable Exhaust Vents
Baffled vents located at floor-level allow filtered air to escape and can be adjusted to maintain cascading pressure levels between rooms
 
  Available Options | USP 797 BioSafe Cleanroom

Environmental Control System
Touchscreen fan controls simplify pressure balancing; sensors  monitor environmental 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 disturbing the cleanroom environment

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

Bootie Butler
Fast, automated donning of shoe-coverings to minimize cleanroom contaminants
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Hands-Free Sink
Hands-free sink and hand dryer in the anteroom boost compliance with hand-washing protocols

Standard USP 797 BioSafe 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 BioSafe Clean Rooms 8-ft Ceiling Height
Overall Dimensions
Panel Type Cat. # Price
10' x 6' 
(3048 x 1829mm)
304 Stainless Steel 2900-72-SS Price
10' x 10'
(3048 x 3048mm)
304 Stainless Steel 2900-91-SS Price
12' x 12'
(3658 x 3658mm)
304 Stainless Steel 2900-94-SS Price
Call Terra to discuss custom sizes or configurations.

Compliance Notice

These BioSafe® 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.


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

File Type File Name Publication Date
Video USP Cleanroom Construction
Time-lapse video showing the installation of a 6' x 10' USP 797 multi-chamber cleanroom. Swing door, windows, flooring, control panel, and ceiling components, including fan/filter units and lighting, are shown.
12/08/2014
Tech Resource (PDF) Calculating Clean Room Cleanliness: How many FFUs and Lights?
This tutorial provides practical tips for correlating the desired cleanliness level (per ISO/FS209 standards) to the required number of fan/filter units (FFUs). Also provides guidelines for specifying lights based on the type of operations being conducted.
05/15/2015
Manual (PDF) USP797 Compounding Cleanroom: Doc # 1800-90
USP cleanrooms are unique in their requirements. See this User Guide to understand your room's function, and how to properly operate and maintain it. Detailed installation instructions with drawings and photos are included in this manual.
08/19/2015
Manual (PDF) Cleaning Procedures #1800-91
A guide to cleaning and sterilizing protocol for modular clean rooms in order to meet your cleanliness requirements: frequency, materials to use and use of equipment.
03/07/2014
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