714-578-6100
M-F, 5:30am - 5:30pm, L.A. Time

USP 797 Compounding Clean Room

Meets USP-797 Requirements!
USP 797 Compounding Cleanroom
Model shown: custom size (12' x 12' buffer room) with optional coved walls and floors.
ISO 5 glass WhisperFlow hood not included.
FM approved logo
Class A FRP and C-PVC panels are
Factory Mutual (FM) approved.
Cleanroom Client List
Dozens of customers for
Terra modular cleanrooms
  • Complete turnkey clean room meets cleanliness standards for control of submicron particles, ensuring a clean compounding environment
  • Internal partition with swing door creates a separate gowning ante-room, in accordance with USP 797 regulations
  • 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
  • Includes two differential pressure gauges to simplify USP-797 certification

Terra's Compounding Clean Rooms provide the ideal environment for compounding sterile injectables and other critical operations.

Designed to meet or exceed the ISO 7 requirements of USP 797, the turnkey rooms include three HEPA filter/fan units that provide a total of 1950 CFM (3315 m³/hr) of 99.99% particle-free air (measured at 0.3 µm diameter). Class C FRP panels meet ISO 7 (Class 10,000) standards, while Class A panels perform to ISO 5 (Class 100) cleanliness requirements, and are Factory Mutual (FM) approved. C-PVC panels meet ISO 5 requirements and are FM approved.

Select between 6'W x 8'L and 6'W x 10'L floor plans, or specify a custom dimension. Both rooms include an internal partition with a swing door that creates a separate antechamber for personnel gowning or product staging. Both the entry and partition doors open inward, allowing workers to avoid potential contamination by backing-in, never having to touch the handles. In the typical configuration, the primary compounding room accommodates a 6'-long workbench, which provides ample space for a laminar flow hood, as stipulated by USP 797 requirements (order bench and hood separately).

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.

Status Indicator
Status light provides
clear indication that
fan filter units are
in operation.

C-PVC Panel Option

Cleanroom chlorinated polyvinyl chloride (CPVC) 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...

Dual Magnehelic® pressure gauges, located on the outer control panel, monitor the cascading pressure levels in the anteroom and main room, simplifying USP-797 certification.

The USP-797 Compounding Clean Rooms below do not include floors; they are designed for installation on a flat, sealed, non-particulating, crevice-free surface, which can be caulked to the clean room frame to form a seal. Talk to a Terra Product Specialist about installation of FRP or C-PVC panels.

Select 7-ft. or 8-ft. ceiling height (filter face to floor).

USP 797 Compounding Clean Rooms 7-ft Ceiling Height 8-ft Ceiling Height
Panel Type Dimensions L x W
nominal
Ft. (mm)
Cat. # Price Cat. # Price
BioSafe Class C FRP Panels 8 x 6
(2438 x 1829)
2900-52C Price 2900-71 Price
BioSafe Class C FRP Panels 10 x 6
(3048 x 1829)
2900-53C Price 2900-72 Price
BioSafe Class A FRP Panels*
Certified ISO 5 compatible
8 x 6
(2438 x 1829)
2900-54C Price 2900-73 Price
BioSafe Class A FRP Panels*
Certified ISO 5 compatible
10 x 6
(3048 x 1829)
2900-55C Price 2900-74 Price
BioSafe C-PVC Panels
Certified ISO 5 compatible
8 x 6
(2438 x 1829)
2900-81 Price 2900-83 Price
BioSafe C-PVC Panels
Certified ISO 5 compatible
10 x 6
(3048 x 1829)
2900-82 Price 2900-84 Price
Includes (3) filter/fan units, (1) fluorescent light, (2) Magnehelic® gauges, air speed gauge, internal swing door, tempered-glass viewing window, 115V/60Hz duplex outlet, and external swing door
* See descriptions above.

® Magnehelic is a registered trademark of Dwyer Instruments.


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 CPVC 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.

Click to leave a message. 24-hour sales and tech phone support, M - F