Containment Isolator

Containment-Isolator
The Ortner PLUS
  • Properties
  • Automated leak test
  • Integrated supply and exhaust air
  • Automated WIP process with rotation and mist nozzles
  • Glove stretching units for a WIP process
  • Integrated dehumidifier for the dry phase following the WIP process
  • Advantages
  • Height safety through validated leak test and
  • WIP process
  • Low sound level of < 57 dB (A)
  • Network-capable: user administration, remote access, time synchronization

Containment solutions from Ortner serve to prevent the release of hazardous materials, during production of solid-based medications for example, since powder particles can be borne through the air. This isolator is washed after use, when the interior is covered in dust from the hazardous materials and the isolator therefore cannot be opened, using an automatic and validated “wash in place”-(WIP)- washing process.



Technical specifications

Overall data of Isolator

  • Cleanroom class at the setup location:
    ISO 8/D or better
  • Total weight of the system, incl. locks 2-glove/4-glove:
    Approx. 900 kg/1100 kg

Media connection points

  • Electric:
    3 x 400 V/50 Hz/5.8 kW
  • Compressed air:
    H14 filtered 6 bar
    AP water 4 - 65 °C, min. 4 bar, 33 l / min
  • Exhaust/supply air:
    110 - 260 m³/h

Control and monitoring

  • Screen navigation with touchscreen user interface:
    9 "
  • PLC model:
    Siemens S7-1500

Protection class

  • Primary:
    Personal & environmental protection
  • Secondary:
    Product protection

Isolator chamber (working area)

  • Cleanroom class in the isolator chamber:
    ISO 7
  • Front pane glass type/seal system:
    single-pane safety glass 15 mm/dynamic
  • Dynamic seal system for the front panel
  • Seal class of the isolator chamber acc. to
    ISO EN 14644-7:
    3
  • Material of the surface touching the product:
    1.4404 Ra < 0,80 μm
  • Illumination level in the working area:
    > 700 LUX
  • Air pressure in the isolator chamber (TARGET):
    -60 Pa to +60 Pa (configurable)
  • Isolator chamber air circulation:
    HEPA H14
  • Chamber cleaning nozzle for AP water

Isolator supply air module

  • Ventilation principle:
    turbulent mixed ventilation
  • Main filter stage:
    HEPA H14

Lock

  • Air pressure in the lock (TARGET):
    -60 Pa to +60 Pa
  • Protective filter air circulation/exhaust air:
    HEPA H14
  • Style of the door to the protection module:
    Sliding door (pneumatic)
  • Style of door to the surrounding space:
    Revolving door, manual, dynamically sealed

Cleaning – WIP process

  • Manual:
    Hand spray
  • Automatic:
    Rotating nozzles
  • Wash media:
    AP water cold/warm, chemical via WIP kitchen
Additional options
  • Material lock right/left with fully integrated, automatic H₂O₂ decontamination
  • Shelf system 150 mm deep
  • Additional sliding tray
  • Integrated temperature and moisture monitoring
  • Intercom system with monitoring camera
  • Remote maintenance access
  • Audit trail
  • Central user administration - Siemens log on*
  • OPC client coupling to a higher-ranking system of the operator
  • RTP port
  • RTP beta port endless liner
  • Outer coating
  • ICH9 risk assessment and GMP qualification IQ/OQ
  • GAMP5 computer validation
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Cleanliness - made in Austria
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