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USP 797 BioSafe® Compounding
Clean Room

usp-797 cleanroom
Model shown: Customized No. 2900-74-SS  
(shown with optional PureDry Hand Washer/Dryer and Labconco RXPert Double-Filtered Hood)
 
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products used for
USP 797 Compounding

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Terra modular cleanrooms

Automated FFU control systems help meet FDA and other compliance regulations. Add options including environmental monitoring and data logging. Click for details

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Terra Universal's USP 797-compliant Compounding Cleanroom uses modular construction to provide a turnkey ISO-rated Buffer Room/Ante-Room combination at an economical price point.  

  • All standard room configurations meet and often exceed the ISO 7 and ISO 8 ratings required by USP 797
  • Adding a single FFU upgrades the ISO classification to at least ISO 6 and smaller rooms can achieve ISO 5 air quality
  • Double-wall, insulated 304 stainless steel panels with radius corners provide smooth, ISO 5-compatible interior surfaces that stand up to daily cleaning and sterilizing procedure
  • Optional Environmental Control Systems can automatically record differential pressure data for auditing purposes
  • Internal partition with two-way swing door creates a separate ISO 8 ante-room for gowning and hand washing
  • Snap-in-place wall panels create a rigid, durable structure that requires no external bracing or ceiling support
  • Recommended Additional Equipment: USP 797-Compliant Sink, Tier II Environmental Control System, and Wall-Mounted Garb Dispensers

These turnkey sterile compounding cleanrooms include: (3) fan/filter units, (2) fluorescent lights, (2) Magnehelic®gauges, (1) air speed gauge, (1) external swing door, (1) internal swing door, (1) tempered-glass viewing window, and (1) 115V/60Hz duplex outlet.


Hidden Costs of FRP Cleanrooms

Why use stainless steel panels when neither FDA nor USP call for them? The answer is simple: everything else costs more in the long run. We know because we tried.

Although FRP (fiberglass-reinforced) panels may seem an attractive approach to an FDA- or USP-compliant cleanroom, hidden installation and maintenance costs pose significant challenges. FRP panel application, a multi-step process requiring an extended installation schedule, involves specialized adhesive, fast-drying and unforgiving seam sealants, and – most critically – installers with the tools and know-how to apply them uniformly and consistently. Mistakes are costly because re-do is nearly impossible and can require cleanroom shut-down and re-certification. Although Terra installers can avoid these problems, projects outside Southern California require travel and living expenses that can extend for weeks. Working with contractors local to you is a hit-or-miss proposition since most lack experience with cleanroom

FRP projects performed to FDA guidelines. To make matters worse, finished FRP rooms cannot be easily modified, expanded, or repaired if damaged by repeated cleaning and sterilizing.

By contrast, Terra modular BioSafe® stainless steel cleanrooms offer both lower cost of ownership and a showcase facility that simplifies certification to FDA and USP regulations. These pre-engineered, quick-connect panels require no installation expertise; rooms typically go up in a day and offer smooth, easy-clean, durable surfaces. Ease of assembly also means ease of relocation; these cleanrooms can be disassembled and reinstalled quickly and inexpensively. Best of all, as a major steel purchaser and fabricator, Terra can offer its BioSafe stainless steel cleanrooms at the same price previously charged for FRP structures.

Given the hidden costs and installation risks of alternative designs, does anything but a BioSafe stainless steel cleanroom make sense?
Certified for Sterile Compounding!
Photos courtesy of MedPilot Pharmacy, San Diego CA
usp cleanroom in exixting room anteroom
Space-efficient footprint allows
easy integration into existing facilities
hands-free entry
Doors open inward for no-hands entry
into anteroom and compounding room
(shown with Purifier Logic Class II, Type 2 Biosafety Cabinet)
Entry to anteroom,
with hands-free sink

Ordering Information - Call Terra to discuss custom sizes or configurations

USP 797-Compliant Compounding Cleanroom

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. Coved vinyl flooring can be added as an optional feature.

USP 797-Compliant Compounding Clean Rooms 7-ft Ceiling Height 8-ft Ceiling Height
Overall Dimensions
L x W
Ft. (mm)
Panel Type Cat. # Price Cat. # Price
8 x 6
(2438 x 1829)
304 Stainless Steel 2900-52C-SS Price 2900-71-SS Price
10 x 6
(3048 x 1829)
304 Stainless Steel 2900-53C-SS Price 2900-72-SS Price
10 x 10
(3048 x 3048)
304 Stainless Steel 2900-37-SS Price 2900-91-SS Price
12 x 12
(3658 x 3658)
304 Stainless Steel 2900-75-SS Price 2900-94-SS Price
Call your Terra Product Specialist to discuss installation options.

Ask the USP Expert

Chris Munoz
Compounding pharmacists face a challenging regulatory environment that is rapidly evolving as state standards move into compliance with FDA and USP mandates. It's important to work with an equipment supplier that understands the complexities of licensing and accreditation procedures.

Schedule a one-hour consultation with Chris Munoz, PharmD to help clarify how the regulations impact your facility and what equipment you are required to use for your compounding activities.

Dr. Munoz teaches pharmacy compounding at the University of Southern California (USC) School of Pharmacy, and serves on the California Pharmacists Association's Policy Committee and Board of Directors. Following Chris's earlier work in compounding pharmacies and for pharmaceutical companies, he began a consulting firm specializing in the business of, and regulatory affairs for, pharmacy compounding.

Chris is an active member of the International Academy of Compounding Pharmacists. He earned his Doctor of Pharmacy degree at the University of Southern California, and his Masters of Business Administration at Chapman University's George L. Argyros School of Business and Economics.

Talk to your Terra Product Specialist to arrange for a private, consultative conversation.

503A Traditional Compounding Pharmacies and 503B Outsourcing Facilities:

How to Optimize Your Compounding Cleanroom for FDA Inspections

As a result of the 2013 Drug Quality and Security Act (DQSA), all traditional compounding pharmacies and outsourcing facilities are subject to FDA oversight. Since enactment, the FDA has taken aggressive steps to strengthen enforcement and implement stricter standards for sterile compounding. Any “insanitary conditions” are in direct violation of Sections 501(a)(1) and (a)(2)(A) of the FD&C Act (Title 21 CFR), which gives the FDA inspectors broad secretion for determining what constitutes sterile conditions.

Because adverse events and sterility test failures are a surefire way to attract the undivided attention of the FDA and State Board of Pharmacy, experts in the field of pharmaceutical compounding strongly recommend using an ISO 5 cleanroom to substantially lower the bioburden of the cleanroom environment and restrict the number of colony-forming units (CFUs) introduced into the critical areas.

Specify the following for compliance with cGMP requirements:

  • 1 additional FFU in the Buffer Room
  • 1 additional FFU in the Ante-Room
  • Tier II Environmental Control System

Please contact us to add these options to your compounding cleanroom.

Visit our USP/cGMP resource page for more information including a Terra webinar presentation and a white paper explaining the facility requirements for compounding pharmacies.


Recommended Options for USP 797 Compounding Cleanrooms


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

USP 797-Compliant Sink

A cleanroom-compatible, hands-free sink is required in the ISO 8 Ante-Room to allow for antiseptic hand-washing prior to entering the Buffer Room and donning sterile gloves.
Foot Pedal Operated Hands Free USP 797 Compliant Sink
  • Constructed of 304 stainless steel for durability and cleanliness
  • Choose between foot-operated or electronic eye sensor models
  • Pedestal-style sink with a 4.75" diameter sump
  • Marine edge design helps prevent spills and splashes
  • Includes a soap dispenser and basket drain
  • One Year Manufacturer Warranty
  Faucet Operation Cat. # Price
P1916 Foot Valve 1372-90 Price
P1916FE Electronic-Eye Sensor 1372-91 Price

Tier II Environmental Control System

For optimal performance and fast configuration, select Terra's Tier II Environmental Control System, which allows easy monitoring, control and documentation of critical room pressures. These systems help you bring your compounding room to target operational levels quickly and easily, and optional Ethernet connection provides the traceable operational history required by USP and cGMP regulations.

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 Price

Wall-Mounted Glove Dispenser

A space-saving wall-mounted glove and garb dispenser can be conveniently located within the Ante-Room to facilitate the required gowning procedures.
wall-mount glave dispenser
  • All dispensers are designed to simplify cleaning and sterilization
  • Swing-open lids allow for easy loading
  • Multi-chamber models are available to accomodate different sizes or types of garb
  • Available materials include polypropylene, 304 stainless steel, and 316 stainless steel
  • Custom inserts and designs are available to fit your garbing routine

See Terra's glove and garb dispenser selection here.

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Door and Window Options


window
Automated Sliding Doors
A no-touch motion sensor opens sliding door for passage into or out of the clean room. Get single or double doors to transport personnel and carts with hands-free operation. Sliding doors conserve forward space and close automatically to preserve pressure and cleanliness within the controlled environment. Urethane wheels stay locked in upper and lower tracks to ensure smooth sliding, and a microprocessor monitors door position to adjust speed of movement and braking. Visit Automatic Sliding Door Systems for more details and ordering information.

window
Automated Swing Door Opener
For hands-free door opening when side-to-side space may be an issue, opt for Terra’s Automated Swing Door Opener. The space-saving unit fits above the swing door; trigger the door motion with the swipe of a hand in front of the sensor pad. Operation is quiet and open/close speed is programmable. An on-board power supply eliminates the need for secondary power. This opener can be installed on single or double doors, and is ADA-compliant. Visit Automatic Swing Door Opener for more details and ordering information.

 


window
Tempered Glass Window
The 0.5" double-paned tempered glass window is secured between two 304 stainless steel retaining frames; the internal frame has no fasteners or other cleaning obstructions. Standard size: 47"W x 36"H (nominal); specify other desired size.

  Cat. # Price
Tempered Glass 6600-45A Price
Fire-Rated Glass 6600-46A Price
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Untitled Document


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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