- Available ISO Rated Designs: ISO 5, ISO 6, ISO 7, ISO 8
- Crevice-free design includes rounded corners for easy disinfection
- Reduces bio-burden in critical compounding zone
- Complies with USP <797> requirements for sterile, non-hazardous compounding
- Does not produce contaminants during sterilization process
- Designed for life science applications, such as genomics, proteomics and food science
Shown is an all stainless-steel USP797 compounding room, including ante-room and buffer room | 2900-94-SS displayed
2900-PP-03
2900-PP-03 72032
USP 797 BioSafe® All-Steel Cleanrooms
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Manufactured By: Terra Universal
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Summary
- Available ISO Rated Designs: ISO 5, ISO 6, ISO 7, ISO 8
- Crevice-free design includes rounded corners for easy disinfection
- Reduces bio-burden in critical compounding zone
- • Complies with USP <797> requirements for sterile, non-hazardous compounding
- Does not produce contaminants during sterilization process
- Designed for life science applications, such as genomics, proteomics and food science
- Free-standing structure is constructed of 304 stainless steel
- USP 797 BioSafe® Cleanrooms combine high durability with exceptionally smooth interior surfaces with coved corners for easy cleaning and sterilization
- Exceeds USP cleanliness and aseptic requirements
- Modeled after the facilities found in cGMP industries
- Double-wall insulated wall panels allow flush-mounting of power outlets
- Wall structure bolts together and panels snap in place, simplifying installation
- Customer can choose between two sensors for monitoring cleanroom pressure and temperature
- Verify before you buy: Consultation services available to ensure evaluate compliance with USP, cGMP, DQSA and other regulations
- ISO 5 compounding buffer room is physically separated from the ISO 7 anteroom and protected by cascading positive-pressure levels as specified in USP 797
- Wall panels can be sealed with silicone caulking for even smoother surfaces
- Internal partition with 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
- Standard turnkey configurations include HEPA RSR fan/filter units, LED light panels, duplex outlets, 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 797 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
Specifications
• Marks & Listings: UL, ULC
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Watch Terra's Portable HEPA Filtration System Video
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Watch Terra's Video on Pharmaceutical Air Lock Designs
Terra's in stock portable HEPA filtration systems provide high quality and medical grade air filtration for your ambient environment.
Watch Terra's Portable HEPA Filtration System Video
The mobile/ self contained filtration system converts to any room to a negative pressure isolation room which then makes it well suited for medical clinics, schools, waiting rooms and other confined areas.
Airlocks safeguard cleanrooms, preventing cross contamination during transfers
Watch Terra's Video on Pharmaceutical Air Lock Designs
Airlocks are a crucial part of protecting your cleanroom from contamination while maintaining the required ISO rating. By preserving pressure differentials between adjoining rooms, air locks prevent cross contamination when personnel, materials and samples are transferred between contiguous spaces. The pressure cascade created from the gowning room to the personnel air lock to the ISO-rated cleanroom acts as a safeguard against the accidental influx of particles, dust and microbial contaminants.
Features and Benefits
Critical Environment Solutions
Terra's mission is to help customers in highly regulated industries transform the world with critical environment solutions that improve health, safety, performance, and yields. These environments may comply with stringent UL, ISO, IEST, ASTM and OSHA standards and local requirements.
Accredited Technical Cleanroom Expertise
We are committed to provide our clients with a full service solution, from project planning through engineering, product design, manufacturing, procurement, shipping, installation, validation, commissioning, and preventative maintenance. Our team of qualified professionals collaborates with all stakeholders to deliver innovative solutions at every stage of the project.
BioSafe: Pre-Fabricated Cleanroom Parts
How can Terra offer industry-leading build times and pricing? Our advanced cleanroom design doesn’t require factory pre-assembly; each component fits together perfectly, ensuring seamless on-site installation
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 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.
Biosafe Cleanroom Control Panel
Standard control panel includes centralized on/off control of lights and FFUs; displays differential pressue in the anteroom and buffer (compounding) room.
Biosafe Cleanroom Exhaust Vents
Adjustable exhaust vents help balance internal room pressure inside BioSafe cleanrooms.
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.
Cleanroom LED Light Panel with Emergency Power Supply, 2' x 2'
Cleanroom LED lights are equipped with emergency back-up batteries to ensure continued operation in the event of a power failure.
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.
4,000 Worldwide Cleanrooms
Since 1976, Terra has designed and manufactured over 4,000 cleanrooms for companies at the leading edge of high technology
Products Tailored to Your Cleanroom Environment
Provide Terra with your desired ISO Grade™ design. We will tailor the product to meet your criteria and certify it with a report appended to your invoice. Certificate includes all the necessary information to streamline audits and facility compliance.
Popular Accessories
For a full list of accessories, select a product then click Choose Accessories on that product page.
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Lighthouse Handheld Airborne Particle Counters
Lightouse portfolio of handheld airborne particle counters ensure accurate readings of cleanrooms and critical environments -
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. -
WhisperFlow Laminar Fan and Filter Units (FFUs)
Equipment enclosures can be equipped with any number of fan/filter units to provide laminar airflow with HEPA or ULPA filtration -
In-Wall Utilities Plumbing
BioSafe cleanrom panels allow flush-mount quick-connect utility fittings. -
Roll-Up Door Pas-Through Chamber
Roll-Up Door Pass-Throughs with interlocked doors -
Cleanroom Access and Automated Fan Controls
Standard panel include pressure gauge, on/off and night switches; security system adds access restriction; automated fan system monitors and controls fan speed, pressure, temperature and RH. -
BioSafe Pass-through Chambers
Pass-through chambers, available for BioSafe Cleanrooms, include interlocked doors that allow contamination-free sample transfer.
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