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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.
 
See all of Terra's
products used for
USP 797 Compounding
 
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.


File Type File Name Publication Date
Tech Resource (PDF) Cleaning Procedures
A guide to cleaning and sterilizing protocol for modular clean rooms
03/07/2014
Manual (PDF) USP797 Compounding Cleanroom: Doc # 1800-90
09/25/2014
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