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USP 797 Compounding Clean Room

usp-797 cleanroom
Model shown: No. 2900-74 with three additional windows,
furnishings and ISO 5 glass WhisperFlow hood (not included)
FM approved logo
Class A FRP and C-PVC panels are
Factory Mutual (FM) approved.
 
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products used for
USP 797 Compounding
 
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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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See Below

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
  • Surfaces and materials are designed to stand up to daily cleaning and sterilizing procedures
  • 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
  • Powder-coated steel support frame creates a rigid, durable structure that requires no external bracing or ceiling support
  • BioSafe® interior Fiberglass-Reinforced Plastic (FRP) or C-PVC panels resist damage from physical contact, and stand up to IPA and other sterilizing agents
  • Recommended Additional Equipment: USP 797-Compliant Sink, Tier III 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.


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
cleanroom on truck Cleanroom on Wheels!
Save on installation time and expense. If your facility allows sufficient access, Terra can factory pre-assemble your cleanroom and arrange for flatbed truck delivery. Assembly of doors, windows and ceiling modules is typically completed in a few hours!

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)
BioSafe Class C FRP Panels 2900-52C Price 2900-71 Price
8 x 6
(2438 x 1829)
BioSafe Class A FRP Panels*
Certified ISO 5 compatible
2900-54C Price 2900-73 Price
10 x 6
(3048 x 1829)
BioSafe Class C FRP Panels 2900-53C Price 2900-72 Price
10 x 6
(3048 x 1829)
BioSafe Class A FRP Panels*
Certified ISO 5 compatible
2900-55C Price 2900-74 Price
10 x 6
(3048 x 1829)
BioSafe C-PVC Panels
Certified ISO 5 compatible
2900-82 Price 2900-84 Price
10 x 10
(3048 x 3048)
BioSafe Class C FRP Panels 2900-37 Price 2900-91 Price
10 x 10
(3048 x 3048)
BioSafe Class A FRP Panels*
Certified ISO 5 compatible
2900-38 Price 2900-92 Price
10 x 10
(3048 x 3048)
BioSafe C-PVC Panels
Certified ISO 5 compatible
2900-39 Price 2900-93 Price
12 x 12
(3658 x 3658)
BioSafe Class C FRP Panels 2900-75 Price 2900-94 Price
12 x 12
(3658 x 3658)
BioSafe Class A FRP Panels*
Certified ISO 5 compatible
2900-76 Price 2900-95 Price
12 x 12
(3658 x 3658)
BioSafe C-PVC Panels
Certified ISO 5 compatible
2900-77 Price 2900-96 Price
*Refer to the FRP Panel descriptions below for more information.
Call your Terra Product Specialist to discuss installation options.

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 III Environmental Control System
  • BioSafe Class A FRP Panels

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 III Environmental Control System

For optimal performance and fast configuration, select Terra's 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
  • 2.4” 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 6602-70A Price
Fire-Rated Glass 6602-71A Price
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FRP Panel Options

Both Classes of FRP panels feature a unique advanced polymer non-outgassing adhesive, allowing installation on surfaces such as drywall. A specialized seam sealant provides trim-free seams that expand and contract to accommodate temperature-induced dimensional changes without creating cracks or gaps. Finally, a patented surfacing technology seals panels uniformly to enhance durability and prevent particle emission and microbial growth.

Class A BioSafe interior panels are the only FRP wall panels certified to ISO 5 standards for added cleanliness, and FM approved for increased safety and fire hazard protection.


BioSafe FRP Wall Panel Specifications
Composition: Random chopped fiberglass in a modified polyester copolymer resin mix, with smooth finish and proprietary surface seal
Thickness: 0.075" (1.9 mm)
Total VOC: 22.16 ppb (Methyl methacrylate): 1.66 ppb (ISO 16000-9) - FDA and USDA approved
Color: White

BioSafe FRP Wall Panel Certifications*
  1. Particle emission ISO Class 5 – 8 per ISO 14644-1
  2. Meets USDA/FSIS (US Dept of Agriculture/Food Safety Inspection Service) requirements
  3. Does not support mold or mildew (per ASTM D3273 and ASTM D3274)
  4. Meets minimum requirements of major model building codes for Class A interior wall and ceiling finishes of flame spread ≤ 25, smoke developed 450 or less (per ASTM E-84)
  5. Meets requirements of ASTM D5319 for Classification Class A / Grade 5 (refers to standard specifications for materials, workmanship and physical requirements)
  6. Factory Mutual (FM) Approved under FM Research Approved FRP, Class 1 Interior Finish Material in accordance with FM Research with Canada and the United States Approval Standard 4880
  7. Biological Resistance rating of 0 – Excellence per ISO 846

*ISO 5 and FM ratings apply to Class A FRP panels.


BioSafe Cleanroom C-PVC Wall Panel Certifications
  • Particle emission ISO Class 5 – 8 per ISO 14644-1
  • Factory Mutual (FM) approved for class 4882, Plastic Interior Wall Finish Material for use in Smoke Sensitive Occupancies*
  • American Society of Testing and Materials (ASTM) E-84: Test for surface burning characteristics of building materials
  • ASTM D 638: Standard test method for tensile properties of plastics
  • ASTM D 790: Test methods for flexural properties of unreinforced and reinforced plastics and the electrical insulating materials
  • ASTM D 256: Test methods for determining the izod pendulum impact resistance of plastics
  • ASTM D 648" Test method for deflection temperature of plastics under flexural load in the edgewise position

*Certified only for installation onto walls less than 30-feet high using BioSafe C-PVC installation materials.


C-PVC Panel Option

Cleanroom chlorinated polyvinyl chloride (C-PVC) wall panels are tested and certified to meet ISO 5 – 8 cleanliness standards. These compressed panels also offer excellent chemical resistance and prevent particle emission and microbial growth.

Their unique solvent-free silicone adhesive allows installation on wallboard substrate mounted to Terra's steel frame structure, creating a strong, rigid structure. Seams are welded to provide trim-free seams, without cracks or gaps. Optional PVC coving is available for floors and corners to further simplify cleaning (see photo above). More information on C-PVC panels...


® Magnehelic is a registered trademark of Dwyer Instruments.

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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, using fiberglass reinforced plastic (FRP) panels. 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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