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USP 800 BioSafe® Clean Room
For Hazardous Drug Compounding

 
USP 800 BioSafe Cleanroom
Custom cleanroom layout with dual compounding cleanrooms and HEPA-filtered outside corridor;
USP 800 BioSafe Cleanroom identifiable by the white exhaust plenum
 
usp-797 cleanroom
Model shown: Customized No. 2899-06-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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See Below
Based on the design of the USP 797 BioSafe Cleanroom, the USP 800 BioSafe Cleanroom is designed specifically for compounding sterile hazardous drugs, such as antineoplastics or hormonal therapies. A negative-pressure Buffer room prevents the spread of contamination to the rest of the facility, while an exhaust plenum attaches to the cleanroom vents to allow removal of the contaminated air. Unique to the BioSafe line of pharmacy cleanrooms, the seams between wall panels can be sealed with silicone caulking to stop unclassified air from entering the Buffer room as a result of the negative-pressure differential.
  • Requires a customer-furnished exhaust system capable of releasing contaminated air outside of the building in volumes equivalent to the air volume generated by the fan/filter units
  • Included exhaust plenum provides flanges for connection to the existing in-house exhaust system
  • Standard layout features a negative-pressure ISO 7 Buffer room and a positive-pressure ISO 7 Anteroom
  • HEPA fan/filter units are controlled by the included Tier 2 Environmental Control System with touchscreen interface and data-logging capabilities
  • Stainless steel walls and rounded corners minimize the buildup of contamination inside the Buffer room and facilitate cleaning in the Anteroom
  • 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 aesthetics
  • Standard configurations are available at affordable prices (see ordering chart below)
  • Modular design meets any floor plan requirements; 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, tempered-glass viewing window, and 115V/60Hz duplex outlet.

 
  FEATURES & BENEFITS | USP 800 BioSafe Cleanroom

Negative-Pressure Buffer Room
Negative-pressure, ISO 7 Buffer room is protected by the positive-pressure, ISO 7 Anteroom, with cascading pressure levels
Exhaust Plenum
Contaminated air escapes through floor-level exhaust vents in the attached exhaust plenum (vented outside of the building)
Environmental Control System
Touchscreen FFU controller (Tier 2) simplifies pressure balancing and uses sensors to monitor interior conditions

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

Viewing Window
Dual-pane, polycarbonate window is flush with the wall surface and provides a full view of the compounding operation
Alt Text
Stainless Steel Panels
Smooth, durable 304 stainless steel walls hold up against IPA and other cleaning agents
 
  Available Options | USP 800 BioSafeCleanroom

Biological Safety Cabinets
Terra provides biological safety cabinets or compounding aseptic containment isolators (CACIs)
Cleanroom Pass-through
Easily transfer materials and finished product without disturbing the cleanroom environment
Hands-Free Sink
Hands-free sink and hand dryer in the anteroom boost compliance with hand-washing protocols

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

Bootie Butler
Fast, automated donning of shoe-coverings helps reduce contaminants in the cleanroom
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Cleanroom Mirror
Flush-mounted mirror minimizes horizontal surfaces for easy cleaning

Standard USP 800 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 800 BioSafe Clean Rooms 8-ft Ceiling Height
Overall Dimensions
Panel Type Cat. # Price
10' x 6' 
(3048 x 1829mm)
304 Stainless Steel 2899-10-SS $ 42,177
12' x 10'
(3048 x 3048mm)
304 Stainless Steel 2899-04-SS $ 53,583
12' x 12'
(3658 x 3658mm)
304 Stainless Steel 2899-06-SS $ 54,711
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.


Custom Room Configurations - Call for Quotes

Non-Sterile-to-Sterile Hazardous Drug Compounding to ISO-800 & DQSA Section 503B Requirements
 
 
Non-Sterile-to-Sterile Hazardous Drug Compounding to ISO-800 & DQSA Section 503B Requirements

Terra Universal's Environmental Control System
All USP 800 models include a Tier II Environmental Control System, which allows pharmacists to configure their compounding cleanroom to optimal operating conditions.  These systems provide automatic monitoring, fine adjustments, and traceable documentation to simplify certification and meet environmental monitoring requirements for 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 storage of 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

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
Video BioSafeĀ® Pass-Throughs
Showing the optimal cleanroom pass-through chamber for aseptic operations, this video provides an overview of the features and benefits of BioSafe pass-throughs.
05/14/2015
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
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