Aseptic Isolator

Aseptic Isolator
The Ortner PLUS
  • fully automated leak test of the entire system with recording of test data
  • operation in positive or negative pressure
  • the unit can also be operated independently from the building ventilation system because of the integrated supply- and exhaust air
  • ready-to-plug-in device
  • can be used in any combination lock and isolator (lock on the right and/or on the left)
  • prepared for fully automatic decontamination
  • for more information please see data sheet or upon request

The aseptic manufacturing method plays an important role, especially in the pharmaceutical industry or in hospital pharmacies. If a product needs to be sterile, contamination must be avoided during product manufacture. An aseptic isolator from Ortner protects the product from contaminants in the environment. Positive pressure is maintained in the isolator in order to ensure that particles from the setup room will not enter the isolator and contaminate the product in the case of even a very minimal leak.



Technical specifications - Isolator

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/1200 kg

Media connection points

  • Electric:
    3 x 400 V/50 Hz/5.8 kW
  • Compressed air:
    H14 filtered 6 bar
  • Exhaust/supply air:
    260 m³/h

Control and monitoring

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

Protection class

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

Isolator chamber (working area)

  • Cleanroom class in the isolator chamber: 
    ISO 5 / A
  • Front pane glass type/seal system:
    single-pane safety glass 15 mm/dynamic
  • Seal class of the isolator chamber according to 
  • ISO EN 14644-7:
    4
    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):
  • +30 Pa (configurable)
    Protective filter air circulation:
  • HEPA H14
    Removable floor:
  • 2 pieces
    Sterility testing pump:
  • fully integrated

Isolator supply air module

  • Rectified flow (low-turbulence displacement flow):
    0.45 m/s +/- 20% (configurable)
    Main filter stage:
  • HEPA H14

Lock

  • Air pressure in the lock (TARGET):
    +15 Pa
    Protective filter air circulation/exhaust air:
  • HEPA H14
    Style of the door to the protection module:
  • Sliding door, pneum. operated
    Style of the doors to the surrounding area:
  • Revolving door, manual, dynamically sealed

H₂O₂ decontamination

  • Isolator ready for H₂O₂ decontamination'
    Decontamination level:
  • LOG6
Additional options
  • Fully automatic glove test unit with port recognition and logging
    Glove extension device for all ports
  • Adjustable height of isolator
  • Material lock right/left with fully integrated automatic
    H₂O₂ decontamination
  • ISU-H₂O₂ generator with catalyzer
  • Air cooler suitable for achieving more precise temperature control, incl. control and monitoring for H₂O₂ decontamination
  • 230 V socket, USB- or RS432 connection in the isolator chamber
  • Shelf system 150 mm deep
  • Integrated online particle monitoring for 0.5 and 5 μm, with logging, H₂O₂-resistant
  • Integrated air samplers
  • Integrated temperature and moisture monitoring
  • H₂O₂ concentration measurement HC/LC sensor
  • Intercom system with monitoring camera
  • Touch panel 19”
  • 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
  • ICH9 risk assessment and GMP qualification IQ/OQ
  • GAMP5 computer validation
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