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USP 797 BioSafe® Compounding Aseptic Isolators: Stainless Steel

Manufactured By: Terra Universal

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Chamber Material All 304 Stainless Steel Stainless Steel, 316L Grade Sort Order: Descending Ascending	Window Material All Polycarbonate Sort Order: Descending Ascending	Chamber Width All 46" Sort Order: Descending Ascending	Chamber Depth All 22" Sort Order: Descending Ascending	Chamber Height All 38.5" Sort Order: Descending Ascending	Light Fixture All Fluorescent Illuminator Sort Order: Descending Ascending	Voltage All 240 V 120 V Sort Order: Descending Ascending	Number of Glove Ports All 2 Sort Order: Descending Ascending	Terra Part #	Price	Ships in
304 Stainless Steel	Polycarbonate	46"	22"	38.5"	Fluorescent Illuminator	240 V	2	2900-56B-220	$10,805	35-43 Days
304 Stainless Steel	Polycarbonate	46"	22"	38.5"	Fluorescent Illuminator	120 V	2	2900-56	$10,135	1-3 Days
Stainless Steel, 316L Grade	Polycarbonate	46"	22"	38.5"	Fluorescent Illuminator	240 V	2	2900-57B-220	$12,992	35-43 Days
Stainless Steel, 316L Grade	Polycarbonate	46"	22"	38.5"	Fluorescent Illuminator	120 V	2	2900-57B	$12,992	35-43 Days
304 Stainless Steel	Polycarbonate	46"	22"	38.5"	Fluorescent Illuminator	120 V	2	2900-56B	$11,280	1-3 Days

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Product Details

Designed in the USA

• HEPA filtration maintains ISO Class 5 conditions in work area

• Optional 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 and are easy to sterilize

• 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

• 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 BioSafe® Compounding Aseptic Isolators: Stainless Steel

Standard Features

A HEPA filtered
HEPA filtration module provides vertical laminar airflow
B 10" glove ports
Main processing chamber includes IV rod and 10" (254 mm)-diameter glove ports (shown with optional hypalon gloves)
C Antechamber
Antechamber with separate 1/2"-thick glass access door
D Differential pressure gauges
Differential pressure gauges display internal positive pressure
D Differential pressure gauges
Differential pressure gauges display internal positive pressure
E Status Indicator
Status 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

Tilt-Up Access Door

Ergonomic LiftLatches and gas struts simply 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.

Rod for Hanging IV Bags in Compound Aseptic Isolator

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).

Compounding Aseptic Isolator Sliding Glass Door

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 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.

Glove Box Cord Feed-Through

A self-sealing port can be mounted in the lower-rear corner of the glove box chamber for passing cables or tubing into the isolator. Feed-throughs are also available for gas, vacuum and other electrical connectors.
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.