Sterility Test Isolator

Sterility Test Isolator
The Ortner PLUS
  • Properties
  • Integrated supply air and exhaust air makes it possible to use the unit independently 
  • Fast and fully integrated LOG6 decontamination using H₂O₂ and very low residual concentration from < 0.5 ppm at the end of the decontamination phase
  • Electric height-adjustable workplace for sitting and standing postures (+/- 150 mm)
  • Advantages
  • Fully automatic LOG6 decontamination using H₂O₂ with logging
  • Low sound level of < 57 dB (A)
  • Network-capable: User administration, remote access, time synchronization, access control

Sterility test must be performed for pharmaceutical products, regardless of their composition, type of application, and batch size. The specification: There can be a probability of the presence of microorganisms of <10-6 in the sample. The sterility test isolators from Ortner are capable of meeting these high standards, though two important factors must be present:

  • The fully automatic and validated decontamination using H₂O₂ on the LOG6 level in order to prevent false-positive test results.
  • The safe removal of the H₂O₂ before the test commences in order to prevent false-negative results.


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
  • 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

Isolator supply air module

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

H₂O₂ decontamination

  • Isolator ready for H₂O₂ decontamination
  • Decontamination level:
    LOG6
Additional options
  • Fully automatic glove testing system with port recognition
    and logging
  • Glove extension device for all ports
  • Adjustable isolator height
  • 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 RS432-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
  • ABL filter, UML filter
  • Integrated sterility testing pump
  • Liquid container for a pump
  • ICH9 risk assessment and GMP qualification IQ/OQ
  • GAMP5 computer validation
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