Product Protection Isolator
Isolators with product protection as an enclosure for aseptic processes (filling, loading/unloading of freeze dryers, etc.). 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 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’.
All safety-relevant functions are constantly monitored electronically.
- Fully welded stainless steel housing in a double-wall construction or 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 circulation 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 directly injected vH2O2 (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
- LED lighting
- Integration of transfer systems
- Integrated PLC control system with 15“ touch panel
- Technical documentation according to the Machinery Directive
- Qualification documentation
- GMP/FDA-compliant design
- CE declaration of conformity