Cytostatic Isolator

Cytostatic Isolator
The Ortner PLUS
  • Properties
  • Integrated supply air and exhaust air makes it possible to use the unit independently 
  • Touch panel in the isolator chamber for operator programs for production monitoring of cytostatics
  • Electric height-adjustable workplace for sitting and standing postures (+/- 150 mm)
  • Advantages
  • Inside automatic sliding doors for easy loading and unloading of the lock system
  • Low sound level of < 57 dB (A)
  • Network-capable: User administration, remote access, time synchronization, access control

Cytostatics are hazardous materials that are carcinogenic, mutagenic, or toxic to the reproductive system (CMR): When it is necessary to protect the person outside of the isolator from the product and to protect the product itself from contamination during manufacture, this is when Ortner cytostatics isolators are used. It offers full separation of the operator and process using special air supply and handling via gloves. Negative pressure is maintained in the cytostatics isolator: Even in the case of a minor leak, no substances will be able to leak out.


Raised floor

A perforated raised floor that can be adapted to the process conditions ensures the homogeneity of the laminar flow up to the working level. For critical processes, the hole design is determined through a CFD simulation.


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/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 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 5/A
  • Front pane glass type/seal system:
    single-pane safety glass 15 mm/dynamic
  • Seal class of the isolator chamber to
    ISO EN 14644-7:
    3
  • Material of surface touched by the product:
    1.4404 Ra < 0,80 μm
  • Illumination level in working area:
    >700 LUX
  • Air pressure in the isolator chamber (TARGET):
    -30 Pa (configurable)
  • Protective filter air circulation:
    HEPA H14
  • Removable floor:
    2 pieces

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):
    -60 Pa
  • Protective filter air circulation/exhaust air:
    HEPA H14
  • Style of the door to the protection module:
    Sliding door (pneumatic)
  • 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 testing device 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 sockets, 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 sampler
  • 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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Cleanliness - made in Austria
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