- HEPA filtration maintains ISO Class 5 conditions in work area
- Air lock reduces contaminant inflow during sample transfer
- Meets USP 797 regulations for sterile pharmacy compounding
- Types 304 and 316L stainless steel provide excellent corrosion-resistance
- Will not produce contaminants during disinfection
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2900-PP-02 72031
USP 797 BioSafe® Compounding Aseptic Isolators: Stainless Steel
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Manufactured By: Terra Universal
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Product Details
• HEPA filtration maintains ISO Class 5 conditions in work area
• Air lock reduces contaminant inflow during sample transfer
• Meets USP 797 regulations for sterile pharmacy compounding
• Types 304 and 316L stainless steel provide excellent corrosion-resistance
• Will not produce contaminants during disinfection
• HEPA-filtered antechamber isolates the main chamber from the outside environment and features a sliding glass door
• Hypalon sleeves and 3-groove glove connectors (sold separately) allow operators to easily replace the sterile gloves without opening the isolator and risking contamination
• Rounded corners for easy wipe down of critical zone
• Reduces bio-burden in compounding critical zone
• Large polycarbonate viewing window tilts open for daily deep cleaning or for adding large process equipment
• Magnehelic® gauges monitor internal positive pressure inside the antechamber and main compounding chamber
• Includes externally mounted fluorescent illuminator
• IV rod securely holds hanging IV bags within reach
• Optional waste port available for disposing of materials through glovebox floor or side
• Due to the differences in state-level enforcement of USP 797, please check with your State Board of Pharmacy before installing an isolator outside of an ISO 7 cleanroom
• Do not use with hazardous substances
USP 797 Pharmacy Compounding Aseptic Isolators: Stainless Steel
Standard Features
- A HEPA filteredHEPA filtration module provides vertical laminar airflow
- B 10" glove portsMain processing chamber includes IV rod and 10" (254 mm)-diameter glove ports (shown with optional hypalon gloves)
- C AntechamberAntechamber with separate 1/2"-thick glass access door
- D Differential pressure gaugesDifferential pressure gauges display internal positive pressure
- D Differential pressure gaugesDifferential pressure gauges display internal positive pressure
- E Status IndicatorStatus Indicator
Not Shown: Range of Options - Options include waste chutes and ionizing bar
Not Shown: UV Module - UV Module allows fast, effective sanitizing
Low Particle Isolators
USP 797 BioSafe® Compounding Aseptic Isolator, Stainless Steel- Stainless Steel USP 797 Compoudning Aseptic Isolator (CAI)
USP 797 BioSafe® Compounding Aseptic Isolators (shown in 304 stainless steel) provide HEPA-filtered, laminar airflow that protects sterile samples | 2900-56B displayed USP 797 BioSafe® Compounding Aseptic Isolator, Stainless Steel USP 797 BioSafe® Compounding Aseptic Isolators (shown in 304 stainless steel) feature HEPA-filtered, laminar airflow that protects sterile samples, an isolated antechamber, hanger rod and swing-up access door for easy cleaning.
Stainless Steel USP 797 Compounding Aseptic Isolator shown with optional Hypalon gloves/sleeves | 2900-56B displayed Stainless Steel USP 797 Compoudning Aseptic Isolator (CAI) Stainless steel laminar flow glovebox complies with USP 797 Compounding Aseptic Isolator (CAI) requirements. Includes illuminator, hanger rod, dual pressure gauges and separate antechamber. Shown with optional Hypalon gloves/sleeves.
Features & Benefits
Features and Benefits
Compounding Aseptic Isolator Specifications
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Glovebox Specifications
- Overall dimensions: 48.25"W x 28.54"D x 53.72"H (1226 x 725 x 1364 mm), nominal, including fan/filter unit; 46.25"W x 22.25"D x 38.74"H (1175 x 565 x 984 mm), chamber exterior, excluding FFU
- Antechamber: 12.5"W (318 mm)
- Processing Chamber: 32.5"W x 22.25"D x 38.74"H (826 mm x 565 x 984 mm), with pneumatic tilt-up door, 27.13"W x 31.43"H (689 mm x 798 mm) opening
- Housing: 304 or 316L stainless steel, or polypropylene
- Viewing Windows: Polycarbonate, 0.25" (6 mm) thick, with swing access door
- Glove Ports: 10" (254 mm) diameter (order desired gloves separately)
- IV Rod: 0.25" (6 mm) stainless steel rod mounted 9" (228 mm), from the filter face Pressure Gauge: 0 - 0.25" Magnehelic® gauges monitor internal positive pressure
- Lighting: External-mount fluorescent fixture Filter/Fan Unit Specifications
- Filter/Fan Unit: 24" x 48" (610 mm x 1219 mm), low-vibration impeller blower module with direct-drive, continuous-duty three-speed fan and 99.99% efficient HEPA filter (rated @ 0.3 µm particle size); operates at less than 50dBA
- Full-load Amps: 4.3 (for 120V, 60Hz)
- Average CFM: 644 (1094.2 m³/hr)
- Air Speed: 100 (low speed); 120 (medium speed); 140 (high speed)
- Watts: 160 @ 90FPM (0.04 m/s)
- Prefilter/Exit filter: Fiberglass/Polyester
Tilt-Up Access Door
Ergonomic LiftLatches and gas struts simplify daily cleaning of the main compounding chamber and transfer of bulky equipment. A one-piece, thermoplastic gasket seals when the panel is closed and latched.
HEPA-Filtered Antechamber
The antechamber provides an intermediary HEPA-filtered space that prevents cross-contamination of the compounding chamber. A sliding glass door provides separation and maintains a pressure gradient.
IV Bag Rod
The main compounding chamber includes a stainless steel IV rod for suspending IV bags at a convenient height during compounding (hooks not included).
Sliding Transfer Door
A 0.5”-thick tempered glass door glides in a polypropylene track between the antechamber and main chamber, maintaining separation and the USP-prescribed pressure gradient when closed.
Heavy-Duty Quick-Release Door Hinges
The tilt-up front panel pivots on stainless steel hinges that allow the entire panel to be easily detached for maintenance or cleaning; simply disconnect the lift-assist gas struts and slide the door off.
Certification Test Ports
Two ports (normally plugged) allow independent verification of the chamber pressures monitored by the Magnehelic gauges, simplifying certification (the “Ambient” reference port always remains open).
Outside-Mounted Illuminator
Light fixture attaches to outside, giving easy access to fluorescent bulb and power switch. Placed at the top of the glovebox, it doesn’t obstruct viewing.
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.
Available Accessories
Popular Accessories
For a full list of accessories, select a product then click Choose Accessories on that product page.
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High Caliber Hardware
Don’t be concerned about the quality, durability, and craftsmanship of your latches, ports, glides and hinges. Terra’s products are made of long lasting, cleanroom compatible, top tier hardware. -
Sleeve and Glove Assemblies
Sleeve/glove combinations, available in many materials, allow fast, inexpensive glove replacement without removing sleeves from the glove box port (shown: Hypalon with glove/sleeve connectors). -
"Sharps" Waste Port
The side or floor mounted waste port offers easy disposal of sharps or other waste. The 6"-diameter port is flush with the interior of the main chamber and has a 3” flange below the surface for connecting waste containers (includes cover). -
Powder-Coated Steel Stands
Stands are all-welded 2"-square steel tubing with white powder-coated finish and chemical-resistant nylon leveling feet. Raise chamber 30" above floor level. Select optional casters for easy positioning.
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