Sterility Testing Isolator

Product Description

Sterility Testing Isolators with product protection for sterility testing under aseptic conditions. Optionally, a rapid decon hatch can be connected. Product protection is achieved by means of a barrier (isolator housing with glove ports) between the operator and the product. The laminar air flow system, incl. monitored positive pressure control, increases the level of safety for the product.

Products and material are transferred inwards and outwards via a suitable transfer system.

The isolators are decontaminated with vH2O2 (vaporized H2O2) before the sterility test by means of the integrated Bio-Decontamination-System ‘FZ-BDS 12/60’.

All safety-relevant functions are constantly monitored electronically.

Technical Details

Sterility Testing Isolator STI4

  • Fully welded stainless steel housing in a single-wall construction and return air ducts with radial edges and rounded corners
  • Folding, electrically monitored, front panel of safety glass with pneumatic springs, pressure-controlled pneumatic seals and glove ports (glove material: CSM)
  • Integrated sterility test pump (tbd)
  • Shelving systems for storing consumables
  • Laminar air flow recirculation system and positive pressure control by means of supply and exhaust air units
  • Gas-tight, electrically operated butterfly valves on the supply air and exhaust air side
  • Integrated Bio-Decontamination-System ‘FZ-BDS 12/60’  with vH2O2 directly injected (DIS = direct injection system) below the membrane distributor for an effective and stable decontamination process with short cycle times
  • Integrated catalysts for flushing after vH2O2-decontamination (no connection to the on-site ventilation system required)
  • Automatic pressure decay test
  • Leakage rate: 2 vol%/h
  • LED lighting
  • Integration of transfer system Ø270
  • Integrated PLC control system (Siemens S7-300) with 12“ touch panel (B&R)
  • Panel printer for the recording of process data
  • Technical documentation according to the Machinery Directive
  • Qualification documentation
  • GMP-/FDA-compliant design
  • CE declaration of conformity

Sterility Testing Isolator STI4c

(For the design, see STI4 incl. following additional equipment for the containment model:)

  • Additional bag in/bag out HEPA recirculation filter H13 under the tabletop for contamination-free filter changes

Rapid Decon Hatch RDH

  • Fully welded stainless steel housing in a single-wall construction and return air ducts with radial edges and rounded corners
  • Interlocked, electrically monitored safety glass airlock doors with pressure-controlled, pneumatic seals
  • Transfer cart for loading consumables into the isolator
  • Laminar air flow recirculation system and positive pressure control by means of supply and exhaust air units
  • Gas-tight, electrically operated butterfly valves on the supply air and exhaust air side
  • Supply via the isolator's integrated Bio-Decontamination-System „FZ-BDS 12/60“ with vH2O2 directly injected (DIS = direct injection system) below the membrane distributor for an effective and stable decontamination process with short cycle times
  • Cycle time: 15-20 minutes
  • Integrated catalysts for flushing after vH2O2 decontamination (no connection to the on-site ventilation system required)
  • Automatic pressure decay test
  • Leakage rate: 2 vol%/h
  • LED lighting
  • Integrated PLC control system (Siemens S7-300) with 12“ touch panel (B&R)
  • Technical documentation according to the Machinery Directive
  • Qualification documentation
  • GMP-/FDA-compliant design
  • CE declaration of conformity