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BioSafe® FRP/C-PVC Modular Cleanrooms

Terra's BioSafe FRP and C-PVC Cleanrooms provide the ideal contamination-free processing environment for bio/pharmaceutical and other operations requiring an environment that's easy to clean and sterilize.

Completely free-standing, these structures can be installed inside a warehouse or other unclassified spaces to create an ISO 5 – 8 cleanroom, typically in a few days and without the need for costly, time-consuming permitting.

Hardwall CleanroomBioSafe Cleanroom: The look and feel of a brick-and-mortar cleanroom,
with the price and versatility of a modular structure (shown with exterior
drywall finish and fast-response automatic double-doors)
 
Tight on space?
Consider a BioSafe® Cleanroom Conversion System
transform an existing room into an ISO 5 – 8 cleanroom!
 
FM approved logo  
Cleanroom Client List
Dozens of customers for
Terra modular cleanrooms
Class A FRP and C-PVC panels are
Factory Mutual (FM) approved.
 

 
Features Key
  Standard
  Option

A HEPA or ULPA fan/filter units provide a laminar flow of micro-filtered air
B Status Indicator Lights: indicate that fan/filter units are operational
C Ceiling Panels available in polypropylene, acrylic or fire-safe steel
D Fluorescent or LED lights
E Display Panel includes fan/filter and light controls, internal pressure gauge(s) and controls for selected options
F Door options include swing door and IR-activated fast-response sliding doors
G Internal wall panels: choose FM-approved FRP or C-PVC, or non-FM FRP; exterior walls are finished wallboard
H All-steel ceiling grid securely holds ceiling panels in place for easy cleaning
  Steel support structure provides rigid, free-standing structure—no external bracing or ceiling suspension
  Options include Night Service setting, pass-throughs, A/C, vacuum, DI water and gas utilities
  canada and us Ul logo
See Below
Terra cleanroom walls are made of durable, easy-to-clean, ISO-grade materials, as specified in FDA guidance documents. Combined with your cGMP processes, they will help you comply with operational requirements.
 
Automated FFU control systems help meet FDA and other compliance regulations. Add options including environmental monitoring and data logging. Click for details

See information below to specify cleanroom accessories, including tempered glass viewing windows, pass-through chambers, coved corners along vertical walls and flooring, and ceiling components (FFUs, lights, power distribution modules). Standard ceiling height is 7' (filter face to floor); specify other desired dimensions. Rooms are designed to accommodate equipment such as biocontainment workstations. See Terra''s explanation of BioSafety Levels (BSL).
Ordering Information
BioSafe Cleanrooms    
  Cleanroom with Welded Ceiling Grid
Panel Type Cat. # Price
Class C FRP 6601-80 Price
Class A FRP 6601-81 Price
C-PVC 6601-82 Price
BioSafe®: Terra's Ultimate Cleanliness Rating
Terra's BioSafe products meet design and material standards that go far beyond conventional cleanroom requirements.

Developed specifically for aseptic requirements in bio-pharmaceutical cleanrooms, these items incorporate a range of features that minimize particle generation and accumulation and inhibit microbial growth. Learn more . . .

Declaration of UL Listing
Includes 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 while ensuring the safety and integrity of electrical components.
Cat. # Price
6600-33 call TUI
 

  FEATURES & BENEFITS | BioSafe FRP/C-PVC Cleanrooms
Alt Text
Sealed Wall Paneling
Fiberglass-Reinforced Plastic (FRP) panels use a specialized seam sealant while C-PVC panels are welded together at the seams.
Modular Steel Frame
The modular design combines versatility and affordability while maintaining the look and feel of a conventional cleanroom.
Power Outlets
Power outlets and other utilities can be added and will receive the same sealing treatment as the wall panels.

Polymer Panel Adhesive
A non-outgassing polymer adhesive designed for cleanrooms permanently attaches the wall panels to the substrate.

Flush-Mounted Exhaust Vents
The exhaust vents provide a smooth, cleanable surface and feature an external baffle plate for adjustment of differential pressure levels.

Steel Ceiling Grid
The grid of powder-coated steel joists is supported by the walls of the cleanroom frame, creating a completely free-standing structure.

Specifications, Certifications, and Accessories

BioSafe FRP Wall Panel Specifications and Certifications

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 CPVC installation materials.

Cleanroom Accessories

window
Tempered Glass Window
The 0.25" 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

Coved Corners
Coved Corners
White PVC coving can be installed along horizontal or vertical seams to provide easy-clean radius corners. Dimensions: 3.75" x 3.75" x 0.079" thick. Radius: 1.625". Max. length: 8 feet. Seal sealant is used to form a moisture-tight seal between panels on each side.

Cat. # Price
6601-61 Price

Aluminum Frame Sing Door
Aluminum Frame Swing Door
Aluminum frame with choice of acrylic or static-dissipative PVC panel and pneumatic closure. Standard mounting is on right panel of shorter wall; specify other desired location. Standard swing is outward (away from room).

Door Panel Material Single Door
81"H x 36"W
(2057 mm x 914 mm)
Double Door
81"H x 72"W
(2057 mm x 1829 mm)
Cat. # Price Cat. # Price
Acrylic* 6710-14A Price 6704-00A Price
Static-Dissipative PVC 6710-15A Price 6704-01A Price
*Acrylic is damaged by alcohol and other cleaning agents

Automatic Sliding Door
Automatic Sliding Door Systems
These cleanroom sliding doors are available in Single Slide or Bi-Part (double sliding) configurations in a variety of colors and customizable sizes. Models meet the demands of research, healthcare and educational institutions. Advanced security and safety options are available.
  • All glass doors minimize obstructive sight lines and provide hand-free entrance into cleanrooms
  • Models include a touchless motion door sensor for hands-free operation of doors
  • Fiberglass reinforced toothed timing belt
  • Microprocessor controller continually monitors door position with adjustable opening & closing speed, distance and speed of braking, reduced opening and time delay
  • Auto reverse on obstruction; slow speed search for obstruction
  • Load-bearing wheels made of cast urethane for long-lasting, smooth and trouble-free operation+
  • Adjustable anti-riser wheels lock each door in its track
  • Toothed drive belt reinforced with fiberglass to prevent slippage and ensures even closing
  • Doors undergo life testing to a minimum of 1 million cycles
  • Quick installation with pre-assembled header and panel sub-assemblies
  • UL listed and ANSI compliant
  • One-Year Manufacturer Warranty for Parts and Labor
All Glass Sliding Door Systems
Description Dimensions Cat. # Price
Dura-Glide 2000 Single Slide 96"h x 92"w (2438.4 x 2336.8 mm) 5555-00 Price
Dura-Glide 2000 Bi-Part Double Slide 147.825"h x 92"w (3754.755 x 2336.8 mm) 5555-01 Price
Optional Features
Cleanroom Rating Class 1 or 2 Cleanroom rating for cleanrooms and computer centers
Wind Resistant Damper Improves safety and lessens repairs costs by withstanding wind gusts two times more than standard door package
Glass Door and Sidelights Provides an aesthetically pleasing appearance
Position Switch Single or Dual
Alarm Contacts Optional
Transom Optional
Threshold Configurations Continuous Double Bevel threshold specified
Emergency Power Options Uninterruptible Power Supply (UPS); extended operation
Fly Open Box; One time operation
Locking options (2-Point locking specified
  • 3-Point Locks
  • Lock position indicators
  • Armored strikes
  • Electric Solenoid Lock (Fail Safe/Fail Secure)
  • Access Control Locking with surface or recessed panic hardware
Specifications
Description Standard Optional
Design Bi-Part of Single Slide
Breakout Series 2000 Sliding Panels Only or Series 3000 Full Breakout
Jamb Dimension 1 3/4" x 4 1/2" 1 3/4" x 6"
Finish Clear or Dark Bronze Special Finish Available
Glass 1/2" tempered with polished edges
Locking Single Point Bottom Rail Deadlock(s) Electric Locking
Controls Rocker Switch Rotary, Keyed Rotary Controls
Sensors 2 SU-100s / Stanguard 2 Wizards
Drive System ¼ HP DC gear driven motor, twin ¼ HP DC gear driven motors (optional)
Material Door Panels: Glass, Aluminum, Wood, Metal or Custom
Compliance UL, cUL, ANSI A156.10, UBC, BOCA, ICBO, NFPA 101
STANLEY SU-100 MOTION SENSORS Uni-directional function reduces length of time door stays open by detecting approaching traffic; saves energy by preserving loss of heat and air conditioning
Stan-Guard® Threshold Sensor Configurable Options: threshold sensor and doorway holding beam detects and holds the door open for people and objects until area is clear
Recessed Panic Hardware Provides security and easy access in emergency situations. Flush mounted panic hardware extends to a minimum of half the door width. Non-handed, single size push bar accommodates door panel widths from 16" to 54" and integrated into a 4/25" muntin bar.
Battery Backup Extends operation of automatic doors up to 1.5 hours in event of power outage or failure

Control Panel
Control Panel
Status Light
Control Panel with Operation Status System
Mounted to the right of the access door, this panel allows convenient control of filter/fan units, lights, ionizing modules, and other environmental monitoring equipment selected for your hardwall modular cleanroom. Fabricated of mirror-finish 304/316 stainless steel or powder-coated steel to match cleanroom design. This system includes top corner indication lights that display cleanroom operation status: lights glow when FFUs (fan/filter units) are in operation, and flash intermittently to indicate they are off. For Hardwall and BioSafe® Celanroom designs only, it includes a Magnehelic® Differential Pressure Gauge (0.25-0-0.25"WC).

Cat. # Price
6600-26-NS Price

Other Cleanroom Accessories
FRP panels
BioSafe interior FRP panels: Class A FM-approved fiberglass-reinforced plastic (FRP) panels provide a 100% sealed, fire-rated, ISO 5-compatible enclosure ideal for aseptic operations (shown with optional coved corners, window and pass-through chamber)
 
These BioSafe Cleanrooms employ a modular design that lets you tailor the system components to your requirements and meet cleanliness standards from ISO 5 – 8 (Class 10 – 100,000).

Ceiling Grid: Rigid Support of Ceiling Components
Terra’s welded grid consists of rigid flat stock members, either powder-coated CR steel or 304 stainless steel, that provide strong, rigid spans of up to 20 feet without external bracing. Longer spans are achieved using interior support posts. Ceiling members lock in place to form 2-foot x 4-foot ceiling bays that support fan/filter units, lights and ceiling panels.

Fan/Filter Units and Lights: Versatile Configuration to Meet ISO Requirements
Select HEPA or ULPA filters to meet your cleanliness requirements; 100% FFU ceiling coverage provides a sweeping laminar flow of micro-filtered air that meets ISO 5 particle requirements. Use the recommended configuration charts below as a guide to creating the appropriate ISO environment for your operation. HEPA filters are rated 99.99% efficient @ particles ≥ 0.3µm diameter, ULPA filters are rated 99.999% efficient @ particles ≥ 0.12µm diameter.

Terra also offers a comprehensive range of specialty FFUs, including room side-replaceable units, reverse flow models that draw out and capture particles generated inside the enclosure, and explosion-proof models. All are UL listed.

Terra offers a number of lighting solutions. For the most critical cleanliness requirements, select energy-efficient LED light strips, which mount to the bottom of the ceiling T-grid. This mounting design allows 100% ceiling bay coverage with FFUs. Fluorescent lights are also available for mounting in ceiling bays.

Power to ceiling FFUs and lights is managed by Terra’s Power Distribution Modules, which house all switches, relays, contactors and circuit protection and allow easy installation of additional modules if requirements change.

More information on FFUs and lights . . .


Steel Support Frame and Panel Choices
The supporting frame is fabricated of interlocking powder-coated square steel uprights and cross sections that create a rigid, self-supporting structure. Fire-resistant gypsum wallboard is attached to the inside and outside of this structure to provide a smooth backing for interior wall panels.

Choose among three panels types:

Class A and Class C FRP
Fiberglass-Reinforced Plastic (FRP) panel systems provide a sealed, cleanroom-compatible surface that’s easy to wipe down and sterilize. Class A panels are the only FRP wall panels certified to ISO standards and FM-approved for fire-safety. Class C panels provide a more economical alternative but without the FM and ISO rating.

Both designs include a patented surface seal that prevents particle shedding, resists staining, inhibits growth of mold and bacteria, and stands up to a broad range of chemicals, including most sterilizing agents.

Class A and C panels are applied to the wallboard substrate with a unique polymer non-outgassing adhesive that adheres to porous and nonporous surfaces. A specialized seam sealant expands and contracts to accommodate temperature-induced dimensional changes without creating cracks or gaps.

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

Their unique solvent-free silicone adhesive allows installation on most substrates. Seams are welded to create a uniform, sealed surface that won’t harbor germs or other contaminants.


A/C Module mounted to return plenum
A/C Module mounted to return plenum, with cooled air ducted to fan/filter units.
Airflow Control and Air Conditioning Systems
Adjustable air vents allow controlled release of air and balancing of internal air pressure to meet ISO requirements. Rooms can be configured for single-pass airflow, or air can be recirculated to FFUs via modular A/C units, allowing control of temperature and humidity.

 


Air recirculation in rooms with many FFUs is typically managed with a double ceiling, which provides a ceiling plenum that provides FFU make-up air. Terra application engineers work with you to develop the most cost-efficient airflow design for your operation.

A central control panel, mounted at the main cleanroom entrance, includes on/off switches for FFUs, lights and other system features. This panel includes connection to Operation Status Indicators located at each corner of the room. These monitors provide a convenient visible indication of proper cleanroom operation: when FFUs are running, they glow continuously; if FFUs are shut down, they flash to indicate a potential problem.

Recommended Air Velocity Rates
Class
Iso 146144-1

(Standard 209E)
Average
Airflow Velocity
m/s (ft/min)
Air Changes
Per Hour
ISO 8 (Class 100,000) 0.005 - 0.041 (1 - 8) 5 - 48
ISO 7 (Class 10,000) 0.051 - 0.076 (10 - 15) 60 - 90
ISO 6 (Class 1,000) 0.127 - 0.203 (25 - 40) 150 - 240
ISO 5 (Class 100) 0.203 - 0.406 (40 - 80) 240 - 480
ISO 4 (Class 10) 0.254 - 0.457 (50 - 90) 300 - 540
ISO 3 (Class 1) 0.305 - 0.457 (60 - 90) 360 - 540
ISO 1-2 0.305 - 0.508 (60 - 100) 360 - 600
Note: Actual average velocity and air changes required may vary depending on the application and floor plan. Source: Institute of Environmental Science
 
Recommended Ceiling Filter Coverage
Class Ceiling Coverage
ISO 8 (Class 100,000) 5 - 15%
ISO 7 (Class 10,000) 15 - 20%
ISO 6 (Class 1,000) 25 - 40%
ISO 5 (Class 100) 35 - 70%
ISO 4 (Class 10) 50 - 90%
ISO 3 (Class 1) 60 - 100%*
ISO 1-2 80 - 100%*
Note: Actual average velocity and air changes required may vary depending on the application and floor plan, including ceiling height.
* ULPA filters required in Class 1/10 applications. HEPA filters required for all others.
Night Service Switch
  • Energy-saving mode saves 25% of fan operating costs by reducing power consumption during off-hours
  • Maintains round-the-clock cleanroom integrity at lower cost
  • Easy to activate via panel-mounted switch (Wireless Cleanroom Control System also available)

Why Pay More for Less?
Terra cleanrooms are designed to meet a specified ISO cleanliness rating when a cleanroom is in use: with operations in progress, process machinery humming, and personnel in motion. So why pay to maintain that level of FFU performance when a production shift ends and people, the greatest source of contamination, leave the room?

With a greatly reduced contaminant load, a cleanroom at rest maintains its target ISO cleanliness standard with much less airflow, fewer air changes—and decreased power consumption. Terra’s Night Service Switch provides this cleanliness at a nominal cost, giving you immediate cost savings.

Simply select the “Night Service” Switch when you turn off the lights and go home. A separate operation circuit drops all Fan/Filter Units (FFUs) into low-energy operation mode, shaving 25% of energy costs off your power bill while maintaining uninterrupted cleanroom performance at your specified cleanliness level. With Terra's Night Service Switch, operators can save up to 7,000 kilowatt-hours per year with a return on investment in slightly over a year.**
Ordering Information
A complete system includes fan/filter units and Terra's standard Power Distribution Modules (order separately), in addition to the units specified below. The Night Service Switch includes electronic configuration of each FFU controlled by this system. The Control Panel includes switch settings and indicator lights for Normal Mode and Night Service Mode, as well as a tamper-resistant master FFU Off switch.
Night Service Switch
Order one per Fan Filter Unit Cat. # Price
120VAC, 60Hz 6601-70 Price
Control Panel for Night Service Switch
Order one per cleanroom 120VAC, 60Hz 220VAC, 60Hz
Cat. # Price Cat. # Price
BioSafe FRP/C-PVC Cleanroom 6600-57-NS Price 6600-57-NS-220 Price
Comparative Specifications:
2’ x 4’ (600 x 1210 mm) Terra Fan/Filter Unit No. 6601-24-H, operating at High, Medium, and Night Service setting
Operation Setting: High Speed* Medium Speed* Night Service
Airflow: cfm (m^3/hr) 808 (1373) 717 (1218) 654 CFM (1111)
Air Speed: ft/m (m/s) 115 (.58) 102 (.51) 93 ft/min (.47)
Run Amps (Watts): 4.3 (512) 3.5 (416) 3.3A (393W)*
*25% savings over operation on high speed
**Based off of an average-sized cleanroom with 10 FFU's, active cleanroom usage of 8 hours per day, and the U.S. Energy Information Administration's given average retail price of electricity at 10.72 cents per kilowatt-hour.

File Type File Name Publication Date
Video On-Site Hardwall Cleanroom Installation
Video showing installation of a hardwall, modular cleanroom at a customer site. The room is tested at the factory, then shipped overseas to be installed. Framing, paneling and utilities are assembled according to the customer specifications.
03/16/2015
Video BioSafe® 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
White Paper (PDF) BSL Explanation
Understand Biological Safety Levels (BSL) by reading this summary of the CDC's specifications for working with infectious agents.
08/05/2015
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
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
Manual (PDF) BioSafe Cleanroom with FRP Panels Doc. # 1788-06
This manual describes the features of the BioSafe FRP cleanroom, shipped components and installation instructions. Additionally, it covers general operation and maintenance of the room.
08/19/2015
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