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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
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
Newsroom
Blog
ILC Dover Acquires Solo Containment, a Leading UK-Based Provider of Products Used in Pharmaceutical and Biopharmaceutical Manufacturing
Blog
ILC Dover Defines the Future of Sterile Manufacturing with the soloPURE™ Flexible Aseptic Isolator
Blog
Webinar: ILC Dover’s soloPURE™ Aseptic Isolator System
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