Terra Part # 2899-04-SS
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64784
Cleanroom; BioSafe®, Compounding, USP-800, 304 Stainless Steel Panels, 12' x 10' x 8'

• Containment Room Dimensions: 8'W x 10'D x 8'H (2438 x 3048 x 2438 mm)

• Ante-room Dimensions: 4'W x 10'D x 8'H (1219 x 3048 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

• (4) 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: 10'

Width: 12'

Overall Dimensions: 12' x 10' x 8'

Panel Material: 304 Stainless Steel

Unit of Measure: EA

Marks & Listings: UL, ULC

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

Weight, Shipping: 1,450 lb

Manuals & Resources

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  13. Qualification Documentation (IQ/OQ) for Terra Universal System
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  14. White Glove Freight Service
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  15. Cleanroom Cleaning Service
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  16. Equipment Testing
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  17. USP 797/800 Consultation
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  18. Cleanroom Installation Information
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  19. Floor Survey Service
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  20. Duplex power outlet: 120VAC shown.  |  6704-34 displayed
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  23. 2'W x 4'D LED panel mounted in Terra Universal Cleanroom; choose models with dimmable brightness and adjustable color temperature for perfect lighting  |  3800-41 displayed
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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.

BioSafe Cleanrooms: No Pre-Assembly

How can Terra offer industry-leading lead times and pricing? Our advanced cleanroom design doesn’t require factory pre-assembly; each components fits together perfectly, ensuring seamless on-site installation

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.

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.

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 provide resistance to chemicals and minimize surface particle shedding. Choose 316L stainless steel as an optional substitute material.

Seismic Safe Cleanroom Design

Terra’s modular cleanrooms are designed with seismic safety in mind. Rigid steel frames and ceiling grids are designed with sufficient factors of safety to provide vertical and lateral strength recommended by professional engineers. Both hardwall and softwall designs can be installed to adhere to local seismic codes. Optional seismic and structural calculations can be drafted and stamped by a licensed PE to help meet municipal permitting requirements.

Continuous Product Improvement

At Terra, we strive to develop and produce the highest quality products for our customers to improve health, safety, performance, and yields. Our product quality is enabled by high-grade manufacturing equipment and processes, 45 years of engineering and application expertise, and our commitment to continuously improve.

4,000 Worldwide Cleanrooms

Since 1976, Terra has designed and manufactured over 4,000 cleanrooms for companies at the leading edge of high technology

Complete Order Transparency

Using Terra’s OnTrak system, our customers can view real-time production updates, receive shipment notifications and track their orders until they arrive at their facility

Comprehensive Service Provider

Terra’s portfolio of services includes white glove delivery, product installation, equipment certification, validation documentation, cleaning and disinfection services, engineering consultation, and structural seismic analysis

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For a full list of accessories, select a product then click Choose Accessories on that product page.
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On a tight schedule? Choose FasTrak 24/7 Priority Service to help meet your critical schedule for Terra-manufactured products, either before or after your order is placed.*

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Call for pricing. FasTrak service fees cover costs of additional services only, without additional profit.

 * Terra's FasTrak services limited guarantee: to ship on the ESD or date specified OR to refund up to 100% of FasTrak charges. This guarantee covers no direct, special, consequential or other damages and is strictly limited to up to 100% of the amount paid for FasTrak service. When a specified ship date is missed due to factors outside Terra's control (vendor performance, deliveries by shipping companies, etc.) and random factors such as accidents, the credit of up to 100% of the FasTrak 24/7 may not apply. FasTrak service requested after order placement will be quoted and accepted based on available time remaining before required ship date.

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