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The skanfog® spectra isolator is the consistent answer to the increased demands of the modern pharmaceutical industry for highest hygiene standards, high efficiency, automation, and digitalization. SKAN uses proven and patented technology for the skanfog® spectra. The integrated SKAN nanox® catalyst and the sophisticated skanfog® decontamination technology optimize every process and guarantee fast and safe cycle times. Whether sterility testing, quality control or industrial preparations, the spectra helps speed up any process and therefore overall efficiency.

 

The main specifications of spectra

  • spectra is suitable for EU-GMP Class D (ISO 8) production environments.
  • Unclassified laboratory for sterility testing in some countries.
  • The isolator provides the highest level of safety for testing, production or quality control.
  • EU GMP Class A (ISO 5) working chamber provides the highest product protection.
  • Integrated skanfog® technology guarantees fast decontamination cycles.
  • Provides various predefined assemblies for individual applications.
  • The unique functionality of the skanfog® spectra

    skanfog® spectra is the latest version of SKANs isolator technology, specifically designed for aseptic and aseptic-toxic applications. Preferred areas of application are sterility testing, quality testing, laboratories, and industrial preparations.

    The independent isolator system uses the most advanced process technology available. It works in a positive pressure operation mode with double HEPA filtration. Neutralization of hydrogen peroxide (H2O2) is ensured by the nanox® catalyst.

    Additional product and operator protection is provided by the integrated skanfog® rapid decontamination system, which carries out automated decontamination cycles including a leak test.

    For control and documentation, a large operating panel reliably records all relevant data of the running processes.

  • spectra – As individual as your process

    The skanfog® spectra isolator is the perfect solution for all aseptic and aseptic-toxic processes. The integrated skanfog® technology is a decontamination technology based on the micro-nebulization of hydrogen peroxide (H2O2). This process allows rapid decontamination in less than one hour, which improves cycle times and increases overall profitability.

    Integrated safe change filters are standard and guarantee operator protection for all operations and aseptic-toxic processes.

    The skanfog® spectra isolator is composed of various predefined assemblies which can be adapted to individual requirements, thus allowing maximum flexibility. The associated Supervisory Control And Data Acquisition (SCADA) is available on Siemens or Allen Bradley platform and complies with current GAMP requirements.

  • Standard practice at the highest level with spectra

    According to current Good Manufacturing Practice (cGMP), aseptic pharmaceutical products require validated aseptic process procedures.

    Sterility testing must be performed in a defined cleanroom environment that is at least equivalent to the current production environment to provide valid results.

    The skanfog® spectra isolator is the most common standard practice isolator on the market for performing sterility testing and aseptic production. Whether your product is aseptic or aseptic-toxic in nature, the spectra isolator improves your testing procedure and confirms whether your process procedure is successful and the batch can be released.

  • Customized workspace with skanfog® spectra isolator

    SKAN offers several configurations and options of the spectra isolator for a variety of processes and applications.

    The isolator can be used for product protection only or for aseptic-toxic purposes, such as in oncology, to provide operator protection as well.

    The isolator system configuration can be selected from predefined assemblies to suit your specific process, such as quality control, research, development, or production.

    Depending on your specific process, the transfer can be completed with two attached rapid transfer airlocks, such as the skanfog® SARA Material Airlock.

  • Automation

    SKAN automated solutions are developed according to current GAMP and fulfil regulatory requirements.

    •  GMP guidelines, CFR 21 Part 11, EndraLex Volume 4
    •  Supervisory control and data acquisition (SCADA)
    •  PLC Siemens or Allen Bradley
    •  HMI Beckhoff Industrial PC
    •  Beckhoff touchscreen monitor 18.5 inches
    •  Active Directory
    •  Decontamination report
    •  Batch report
    •  Audit trail functionalities
    •  Electronic records
    •  Electronic signature
    •  OPC interface
  • Options and accessories

    Optional items:

    • 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 isolator chamber
    • H2O2 HC sensor (high concentration) for isolator chamber
    • Viable monitoring according to your choice
    • Particle Counter (non-viable) according to your choice
    • Glove testing devices with position control function
    • Negative pressure operation mode for special application

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