Personnel and Product Protection

Product Description

Isolators with personnel and product protection as an enclosure for aseptic/toxic processes (filling, loading/unloading of freeze dryers, etc.). Personnel and 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 mouse holes or a suitable transfer system.

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

The work area and return air ducts can be cleaned automatically or manually with water by means of rotating spray nozzles or a spray gun (WIP).

All safety-relevant functions are constantly monitored electronically.

Technical Details

  • Fully welded stainless steel housing in a single-wall construction and return air ducts with radial edges and rounded corners
  • Electrically monitored safety glass doors with pressure-controlled pneumatic seals and glove ports (glove material: CSM)
  • Recorded mock-up study
  • 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 sides
  • 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
  • Automatic pressure decay test or pressure hold test
  • Leakage rate: tbd
  • Spray gun and/or rotating spray nozzles for automatic or manual cleaning with water, drainage by means of an electrically operated diaphragm valve
  • LED lighting
  • Integration of transfer systems
  • Integrated PLC control system (Siemens S7-300) with 15“ touch panel (B&R)
  • Technical documentation according to the Machinery Directive
  • Qualification documentation
  • GMP-/FDA-compliant design
  • CE declaration of conformity