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USP 797 BioSafe®
Compounding Aseptic Isolators

Compounding Glovebox
USP-compliant Compounding Aseptic Isolator, Model No. 2900-56A
 
Features Key
  Standard
  Option

A HEPA filtration module provides vertical laminar airflow
B Main processing chamber includes IV rod and 10" (254 mm)-diameter glove ports (shown with optional hypalon gloves)
C Antechamber with separate 1/2"-thick glass access door
D Differential pressure gauges display internal positive pressure
E Status Indicator
F Powder-coated steel stand with leveling feet
  Options include waste chutes and ionizing bar
  UV Module allows fast, effective sanitizing

cleanliness high

See all of Terra's
products used for
USP 797 Compounding

Meets Current USP 797 Requirements for Compounding Aseptic Isolators (CAIs)

Terra Universal's Compounding Aseptic Isolator uses a HEPA-purged, pass-through design to provide an economical solution for compounding pharmacies to meet the performance criteria for isolators outlined in USP 797.

    ValuLine Compounding Aseptic Isolator Polypropylene construction provides a USP 797-compliant isolator at a lower cost!
  • The ISO 5 positive pressure antechamber isolates the main chamber from the outside environment and features a sliding glass door for easy transfer of compounding materials
  • Low-noise, low-vibration fan/filter unit provides continuous vertical flow of 99.99% particle-free air to meet ISO 5 cleanliness standards
  • Hypalon sleeves and 3-groove glove connectors (sold separately) allow operators to easily replace the sterile gloves without opening the isolator and risking contamination
  • The large polycarbonate viewing window tilts open to simplify daily deep cleanings 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 in easy reach
  • Waste port available for disposing of materials through glovebox floor or side

For compounding hazardous drugs, check out the Compounding Aseptic Containment Isolator


Planning on Using an Isolator Instead of a Compounding Cleanroom?

Please read the following blog post published by Terra, which explains the potential impact of the upcoming revision to USP 797 and answers a few of the most common questions regarding isolator requirements:  Read More...

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.


Compounding Aseptic Isolators
Material 22" Chamber Depth
120VAC 220VAC
Cat.# Price Cat.# Price
304 Stainless Steel 2900-56A $ 8,447 2900-56A-220 $ 8,447
316 Stainless Steel 2900-57A $ 10,356 2900-57A-220 $ 10,356
Polypropylene 2900-58A $ 6,650 2900-58A-220 $ 6,650
Note: Sleeves, glove connectors, and sterile gloves must be ordered separately.
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FEATURES & BENEFITS | Compounding Aseptic Isolators

Tilt-up Access Door
Simplifies cleaning of main work area and transfer of large parts

Ante-Chamber Door
Easy transfer of kitting trays without contaminating the main work area
IV rod
IV Rod
Suspends IV bags at a convenient working height
Swing-up access door
Sliding Access Door
Half-inch tempered glass interior door isolates work area from antechamber, per USP requirements.
Swing-up access door
Heavy-Duty Hinges with Removable Doors
Tilt-up and swing access doors are easy to remove and reinstall to acccommodate cleaning and sterilizing protocol
Swing-up access door
Certification Test Ports
Test ports simplify validation of antechamber and main chamber pressure levels to reduce certification costs

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 316 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 @ 0.3µm 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
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Replacement Parts and Optional Equipment



filter
bag-out waste chute
Replacement Exit Filters
MERV 7 polyester, 1" thick, removable from
inside the chamber (no rear access required)
Waste Port 6" (152mm)
For easy disposal of sharps or other waste
(Choice of side- or floor-mounted)
Replacement Filters Cat.# Price
Main chamber filter 2900-65A Price
Antechamber filter 2900-66A Price
Waste Port 6" (152 mm) dia. Cat.# Price
Glovebox floor mounting * 2900-48 Price
Glovebox sidewall mounting
(Protrudes 3" (76 mm) from sidewall)
2900-49 Price
Bags, 12-mil PVC; package of 10 1694-44 Price
*Standard mounting: 18" (457 mm) from front 7"
(178 mm) from side.
Requires stand or table with 7" (178 mm)-dia. cut-out.


CAI Sleeves and Glove Connectors
Hypalon Sleeve and Glove Connectors
Sleeve/connector assemblies provide physical separation from CSPs and protect the isolator during sterile glove replacement.
Gloveport Assemblies Cat.# Price
Hypalon Sleeve 1671-18 Price
Glove Connector 1671-20 Price
14" Hypalon Glove
Unlined Textured grip
Cat.# Price
Glove size 8 1671-05 Price
Glove size 9 1671-06 Price
Glove size 10 1671-07 Price
One-piece Fully-Dipped
Hypalon Hand & Sleeve
Cat.# Price
Ambidextrous, size 8 1671-21 Price
Ambidextrous, size 9 1671-17 Price
Ambidextrous, size 10 1671-22 Price
cord grip
Cord Pass-Through
Mounted in lower rear corner (as shown).
Specify other desired location.
Optional Ports Cat.# Price
Power Cord Pass-through 2900-70 Price

Glove Box Stand
Stands
Constructed of all-welded 2" (51 mm) square tubing. All stands raise chambers 30" (762 mm) off of floor, add 3"
(76 mm) for casters.
Stands Cat.# Price
Powder-coated Steel Stand 1694-82A Price

Casters  Cat.# Price
Set of 4, 2 with locking brakes 1700-43 Price
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File Type File Name Publication Date
Tech Resource (PDF) Why Use Nitrogen?
A guide to how nitrogen purging protects moisture-sensitive materials.
05/18/2015
Manual (PDF) Compounding Aseptic Isolator: Doc. No. 1800-35
Operating and maintenance instructions for Terra's USP Compounding Aseptic Isolator Glove Box. See our section for preparing the CAI for testing performance and passing inspection.
01/14/2016
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