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Stainless Steel 10' 6' 8' 304 Stainless Steel $41,08425-31 Days
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Stainless Steel 12' 12' 8' 304 Stainless Steel $53,29225-31 Days
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Product Details

Designed in the USA

• Free-standing 304 stainless steel structure meets the requirements of USP 800 for negative-pressure containment in hazardous-drug compounding

• Includes exhaust plenum with flanges for connection to the customer-furnished ventilation system capable of drawing out air introduced by the fan/filter units

• Standard layout features a negative-pressure Buffer room (ISO 7 or 5, depending on requirement) and a positive-pressure ISO 7 Anteroom

• Environmental Control System (included) adjusts fan/filter units via 3.5" color touchscreen interface for easy air balancing; includes pressure sensors, remote and clock-controlled setback/shut-down and data logging capabilities

• Stainless steel double-wall insulated panels with coved corners product a smooth, easy-clean interior; allow flush-mounting of power outlets

• Exceeds USP cleanliness and aseptic requirements

• Wall structure bolts together and panels snap in place, simplifying installation

• Verify before you buy: Consultation services available to ensure evaluate compliance with USP, cGMP, DQSA and other regulations

• Wall panels can be sealed with silicone caulking to eliminate all cracks and simplify disinfection

• Internal partition with two-way swing door allows for gowning and hand-washing prior to entering the Buffer room

• Heavy-duty steel ceiling grid is fully supported by the wall structure; holds HEPA-filtered fan units and LED light panels without need for external bracing

• Specialized pass-throughs can be included for transfer of finished products, minimizing disruptions in your workflow

• Ethernet connection for logging and storing room pressures or other data

• Pressure sensor included in each room

• Individual variable control over all Fan/Filter Units to achieve target flow and pressure levels

• Fan performance and room pressure warning alerts via Ethernet

• Clock-calendar control of energy-saving setback mode

• Standard turnkey configurations include HEPA fan/filter units, LED light panels, duplex outlets, control panels and ante-/buffer room panels and ceiling grid; installed on site

• Modular design meets any floor plan requirements; call for a custom quote!

• These BioSafe® compounding cleanrooms are designed to the requirements 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 with our compounding experts to evaluate suitability for your application

Features & Benefits

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.

Cleanroom LED Light Panel

LED panels mount flush on ceiling grid, have longer life, and use less energy (emitting less heat) than conventional fluorescent lights.

Smooth Interior Walls

Smooth steel BioSafe cleanroom panels with radius corners simplify cleaning and stand up to IPA and other sterilizing agents.

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 Windows

Dual-pane polycarbonate window is flush with the wall surface and provides a full view of the compounding operation.

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.

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.

Available Accessories

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.

Manuals & Resources

Manuals & Resources

USP Cleanroom Customization

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.*

  • FasTrak 24/7 provides a 24/7 commitment to meet the shipping date YOU specify, regardless of quoted lead times.
  • FasTrak 24/7 assigns a dedicated production team plus a dedicated senior expeditor working three shifts to meet your delivery specification.
  • FasTrak 24/7 guarantees* to meet the agreed-to specified ship date.

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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