Getinge Isoflex-R Isolators
Getinge Isoflex-R Isolators
A modular rigid wall isolator with fast bio-decontamination solutions.
The Getinge Isoflex-R Isolator protects the product against contamination during aseptic operations such as sterility testing. The isolator maintains an enclosed and sterile environment throughout transfer, manipulation, and bio-decontamination.
Overview
Isolators narrow containment to just around the process within the chambers, making it easier to trace sources of contamination. Energy consumption can be lower than with a cleanroom, as only the environment inside the isolator needs to be controlled. A modular isolator system provides flexible configuration and modification possibilities to meet your specific process and application requirements.
Modular design for flexible use
The modular design of the Getinge Isoflex-R allows the isolator to be tailored according to your specific needs. Three-glove or four-glove versions are available. Bio-decontamination airlocks can be added at one or both ends of the isolator or between two isolators. A large front window can be easily opened for fast and ergonomic loading. Getinge Isoflex–R is compatible with our full range of DPTE® Transfer Solutions to ensure safe and efficient transfer without breaking containment.
Ventilation to maintain aseptic conditions
With the Getinge Isoflex-R, unidirectional or turbulent airflow can be achieved to meet various process requirements. In this sealed, operator-free environment with control over sources for contamination entry (HEPA filters, transfer ports), turbulent airflow (ETF) is sufficient to maintain sterile conditions. For aseptic applications where it is important to ensure that non-viable particles are rapidly swept away from critical areas, unidirectional airflow (also known as UDAF, LAF, Laminar flow) is appropriate to meet Grade A/ISO 4.8.
Validated process control & traceability
Getinge Isoflex-R offers Siemens or Allen Bradley PLC for process control and monitoring. Both systems provide a 15” color touch panel PC with an intuitive user interface for easy navigation, operation, and parameter monitoring.
As standard, the Getinge Isoflex-R provides built-in SCADA for central supervision of process performance. Authorized users can adjust process parameters according to the unique requirements of a specific process. Batch reports can be digitally stored locally or in the user’s network. Getinge Isoflex-R is fully FDA 21 CFR Part 11 and GMP Annex 11 capable and compliant.
Bio-decontamination alternatives
When it comes to bio-decontamination, the Getinge Isoflex-R provides the means to bio-decontaminate the isolator working chamber, the hatch, or both chamber and hatch simultaneously. The optional Isoturn™ airlock provides fast “flash” bio-decontamination. It is designed with a space-saving rotating door, making it possible to unload while reloading/bio-decontaminating another load. The integrated H2O2 generator ensures safe and reliable operations. The unit is controlled by the same interface as the isolator and provides full traceability of H2O2 bottles.
Upgrades on site
Easily upgrade your Getinge Isoflex-R isolator
Designed for modularity, the Getinge Isoflex-R isolator can be easily retrofitted on site. Bio-decontamination hatches can be added at a later stage, if required. Additional upgrades are available, including environmental monitoring devices, shelving, H2O2 sensors, and Getinge Glove Leak Testers can be added afterwards, providing accurate and repeatable testing for glove and sleeve integrity.
Applications
Reliable sterility testing
Sample contamination during sterility testing can be a costly problem, showing false positives for contamination when in fact there is none. Getinge’s sterility testing applications support efficient workflows and reliable operations to provide an optimal environment for your sterility testing process.
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