PSI-M Isolator

The PSI-M isolator is the ultimate multi-purpose isolator. Due to its modularity, the PSI-M isolator easily adapts to all conditions and applications and can be upgraded at any time. Whether as a sterility tester, incubator, balance or centrifuge, the isolator is suitable for all pharmaceutical and laboratory applications.
The highly flexible isolator system uses the proven decontamination system with vaporized H2O2, making it ideal for aseptic and aseptic-toxic applications.

  • PSI-M offers unbeatable functionality

    PSI-M is an independent isolator system operating in positive pressure mode with double HEPA filtration.
    The required supply air is taken from the surrounding room or technical area. Exhaust air is discharged to the outdoors or back into the room via an optional nanox® catalyst.

    The decontamination system integrated into the isolator performs an automatic decontamination cycle including a leak test, maximizing process and operator safety. Optional safe interchangeable filter boxes (FIBO) also enable processing of aseptic-toxic processes. This allows the PSI-M isolator to be used for all work areas and laboratory environments.

  • PSI-M is the perfect solution for aseptic applications

    The PSI-M isolator system is the perfect modular solution for all traditional aseptic applications. The pre-definition of assemblies and various options improves your individual application and thus offers the highest flexibility. This allows a wide variety of equipment to be successfully integrated to meet your individual requirements for all aseptic-toxic processes, providing the best solution.
    The integrated H2O2 decontamination system guarantees a stable decontamination process, ensuring not only process, but also increased operator safety.
    Our Supervisory Control And Data Acquisition (SCADA) is available on Siemens or Allen Bradley platform and meets current GAMP requirements.

  • Added value through sterility testing with the PSI-M isolator

    Aseptic processes always require validated aseptic process flows in accordance with the requirements of current Good Manufacturing Practice (cGMP). Above all, sterility tests must take place in defined cleanrooms, that should at least correspond to the production environment currently in use, in order to be able to collect valid data.

    The PSI-M isolator is considered the standard practice isolator on the market for sterility testing of aseptic production equipment. Independent of product and filling lines, the PSI-M isolator improves the testing procedure and facilitates the validation of pharmaceutical processes.

  • Customize your workspace with the PSI-M isolator

    SKAN offers various configurations and options of the PSI-M for a variety of processes and applications. The isolator can be used for product protection only or for aseptic-toxic purposes, for example in oncology, to provide operator protection as well.

    The configuration of the isolator system can be selected from predefined assemblies to fit your specific process, such as quality control, research, development, or production. Depending on your specific process, transfer can be enhanced with two attached quick-change airlocks, like the skanfog® SARA Material Airlock.

  • Automation

    Supervisory Control And Data Acquisition (SCADA) according to current GAMP requirements:

    • PLC Siemens or Allen Bradley
    • HMI Beckhoff Industrial PC
    • Beckhoff touchscreen monitor 15,6 inch
    • Decontamination report
    • Audit trail functionalities
    • Electronic records
  • Option and accessories
    • Integrated sterility testing pump
    • Rapid transfer port for solids (RTP)
    • Rapid transfer port for liquids (AT-Port™)
    • H2O2 TLV sensor for room monitoring (operator safety)
    • H2O2 LC sensor (low concentration) for chamber
    • H2O2 HC sensor (high concentration) for chamber
    • Viable monitoring according to your choice
    • Particle counter (non-viable) according to your choice
    • nanox® catalytic converter (operator safety)
    • Glove testing devices with position control function
    • Negative pressure operation mode for special application

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