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soloPURE™ Flexible Aseptic Isolator

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soloPURE™ Flexible Aseptic Isolator

The future of sterile manufacturing is soloPURE™.

ILC Dover’s soloPURE™ flexible aseptic isolator is a cost-effective, closed-barrier system for sterile manufacturing that provides a closed, Grade-A, aseptic environment for fill finish activities requiring positive and negative pressure.

soloPURE™ maximizes efficiency and productivity in the cleanroom through its fully disposable, single-use chamber and double-sided operator access, reduces costs through bolt-on modules for lyophilization that deliver more capabilities without the added expense, and mitigates risk through integrity testing throughout its lifecycle. It is available with the capability to sterilize in-place with VHP or operate with a single-use, disposable gamma-irradiated chamber.

soloPURE™ expands ILC Dover’s portfolio of flexible, single-use systems, delivering significant benefits to biopharmaceutical manufacturers. Its fully disposable, single-use chamber and a CAPEX-efficient compact design, represents the future of sterile manufacturing.

Applications

  • Fill/Finish Activities
  • Sterile Manufacturing
  • Aseptic Processes

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soloPURE™ Flexible Aseptic Isolator

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soloPURE™ Flexible Aseptic Isolator Tech Specs

Why soloPURE™ from ILC Dover?

Fully Disposable, Single-Use Chamber

Fully disposable chamber eliminates the need for cleaning and validation, promoting rapid campaign changeover.

Compact Design and Small Footprint

Complete and compact system optimizes the space in constricted cleanrooms for greater productivity.

Filter and Isolator Integrity Testing

Testable HEPA filters and inbuilt pressure decay testing ensure the integrity of filters and isolators before use.

Easy Bolt-On Modules and Interfaces

Modules for lyophilizer loading or VHP transfer expand processes without expensive equipment.

Automatic Pressure Control System

System automatically balances and maintains the correct pressure and airflow for the operator.

Double H14 HEPA Filter Assembly

Any potent airborne particulate will be captured in the filter system and disposed of, mitigating risk.

Double-Sided Access for Operators

Double-sided working surface allows two operators to work opposite each other, enhancing workflow practices.

System Requirements

Maintain a Grade-A Particle Count
Maintain Unidirectional Airflow Between 0.36m/s and 0.54m/s
Capable of a 6 log kill with VHP & Gamma Irradiation Sterilization
Requires a Grade C or D Cleanroom to Operate Within (depending on process)

Additional Available Features

RTP 105 to 270 Integration
Glove Integrity Tester Available
VHP Generator Supplied
21 CFR Part 11 Upgrade Available

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