Terra Part # 2899-06-SS
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64785
Cleanroom; BioSafe®, Compounding, USP-800, 304 Stainless Steel Panels, 12' x 12' x 8'

• Containment Room Dimensions: 8'W x 12'D x 8'H (2438 x 3658 x 2438 mm)

• Ante-room Dimensions: 4'W x 12'D x 8'H (1219 x 3658 x 2438mm)

• ISO 7 Compounding room with ISO 7 Anteroom

• Materials: Double-wall, insulated 304 Stainless Steel panels with radius corners provide clean, ISO 5-compatible interior surfaces that are easy to clean and sterilize

• Control panel includes Night Setting switch, to conserve power when room is not in operation

• Requires connection to in-house exhaust ventilation fan (not included); minimum required exhaust - 2730 CFM

• Negative pressure containment system meets requirements USP800 for hazardous drug compounding

• Meets USP compliance with Environmental Control System, which monitors room pressures, temperature and humidity

• Containment system ensures safe handling of hazardous drugs in conformance with USP 800

• Compounding rooms meet ISO 7 particle requirements, in accordance with USP 797 and USP 800

• Request UL Listing Declaration (order separately) for cleanroom electrical system, which helps meet municipal and other permitting requirements that may apply

• Compliance Notice: this clean room is built to the specifications of USP 800 as published in USP 40-NF 35; however, because practice standards vary from state to state and depend on compounding operations, Terra recommends consultation to evaluate suitability for your application

• Includes:

• (1) Duplex outlet

• (4) 2' x 4' Room Side Replaceable HEPA Fan Filter Units

• (5) LED Light panels and polypropylene ceiling panels in remaining ceiling bays

• (2) Stainless Steel swing doors with partial view windows

• (1) Tempered glass viewing window per compounding room

• (1) Negative pressure exhaust plenum to ensure hazardous drug containment

• FDA-approved silicone sealant for caulking internal seams

Application: USP 800 (Sterile HD)

Frame Material: Stainless Steel

Height: 8'

Depth: 12'

Width: 12'

Overall Dimensions: 12' x 12' x 8'

Panel Material: 304 Stainless Steel

Unit of Measure: EA

Electrical Specifications: 120 V, 50 A, 1 Ph, 60 Hz

Weight, Shipping: 1,650 lb

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  16. USP 797/800 Consultation
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Features and Benefits

Hazardous Drug Storage

Negative-Pressure HD Storage Rooms

The layout of the USP 800 Hardwall cleanroom can be modified to include a negative-pressure storage room adjacent to the Buffer room. A dedicated HD storage room provides a convenient, USP 800-compliant receiving/unpacking area for HD shipments that does not require cleanroom garb. ISO classification is not required for HD storage rooms; air must simply be exhausted at a rate of 12 air changes per hour (ACPH). The storage room exhaust can often be integrated with the Buffer room exhaust for maximum efficiency.

USP 800 also cautions against placing HD refrigerators in the Buffer room, as the refrigerators tend to harbor contaminants and release significant numbers of particles. The designated HD refrigerator can instead be placed inside the HD storage room.

Adding a HEPA-filtered pass-through in the HD storage room allows operators to easily transfer the HD bag into the cleanroom for manipulation. Prior to compounding, operators can pull the necessary items from storage and place them in the pass-through chamber. The HD ingredients can remain in the pass-through, ready for receipt, until the compounder has gone through gowning and finished all other preparations. Following compounding, the final HD product can be safely transferred back into the HD storage room.

Non-Sterile HD Compounding

According to USP 800, non-sterile HD compounding must also take place within a negative-pressure room that is physically separated from other areas. An exhaust system (directed to the outside of the building) must be used to ventilate the contaminated air and create a slight vacuum (negative-pressure).

The key difference for non-sterile HD compounding is that it does not require HEPA filtered airflow, which can significantly reduce the cost and complexity of building a containment room. Existing HVAC systems can provide fresh air to replace the air removed by the exhaust system.

Because HD contamination can be difficult to clean, non-sterile HD compounding rooms share the same construction features with sterile compounding cleanrooms. Surfaces must be smooth, made of non-shedding materials, and minimize crevices where contamination can collect.

Please contact Terra Universal for quotes regarding USP 800 cleanrooms without the HEPA-filtered FFUs.

Smooth Interior Walls

Smooth steel BioSafe cleanroom panels with radius corners simplify cleaning and stand up to biocides and disinfectants. Cleanrooms constructed with medical-grade and USP-compliant material.

Sterile Buffer Room

Swing door separates ISO 7 Buffer room from ISO 8 Anteroom; ceiling HEPA fan/filters meet USP particle and pressure differential requirements.

Containment Exhaust Plenum

Negative-pressure containment cleanrooms include exhaust plenums that route air to floor- or ceiling-mount fans, protecting the external environment from hazardous materials inside the cleanroom.

Framed Double-Flush Cleanroom Window for Pharmaceutical Compounding Rooms

Dual-pane window sits flush with wall surface, design is free of cracks and crevices where contaminants can aggregate. Design meets USP and medical-grade requirements.

Available Environmental Control System

Standard cleanroom comes with analog pressure gauge and on/off controls; optional touchscreen FFU controller monitors, controls and logs internal pressure, as well as displaying temperature and RH.

Flush-Mount Dual Pane Windows

Flush mount dual-pane window design simplifies cleaning.

Stainless Steel Cleanroom Door

Stainless steel doors provides resistances to chemicals and minimizes surface particle shedding. Choose 316L stainless steel as an optional substitute material.

BioSafe®: Terra's Ultimate Cleanliness Rating

Terra's BioSafe products are designed for life science applications: no gaps and crevices where microbes can colonize, rounded corners for easy disinfection, won't produce contaminants during sterilization, and exceed cGMP, IEST, ASTM and ISO 14644-1 requirements.

Popular Accessories

For a full list of accessories, select a product then click Choose Accessories on that product page.
  • Biosafe Cleanroom Laminar Flow Hood
    Terra provides ISO 5 laminar flow benches, biosafety cabinets or compounding aseptic isolators.
  • Space-Efficient Glove and Garb Dispensers
    Wall-mounted cleanroom garb and glove dispensers save ante-room space and promote clean garbing protocol.
  • Bootie Butler Shoe Cover Dispenser
    Bootie butler shoe cover dispenser applies shoe covers quickly and conveniently, reinforcing clean garbing protocol and keeping contaminants out of the cleanroom
  • Biosafe Cleanroom Hands-Free Sink
    Hands-free sink and hand dryer, seen in cleanroom anteroom, boost compliance with hand-washing protocol.
  • Cleanroom Biosafe Mirror
    Cleanroom Biosafe mirror minimizes cracks where germs collect, helps guarantee correct garbing protocol (frameless design shows).
  • BioSafe Pass-through Chambers
    Pass-through chambers, available for BioSafe Cleanrooms, include interlocked doors that allow contamination-free sample transfer.
  • Germicidal UV Lamp Sanitizes Labs, Cleanrooms
    UV-C Germicidal Lamp installs on a cleanroom ceiling grid for line-of-sight room disinfection; safety occupancy sensor prevents personnel exposure.

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