Модель

Product Protection Isolator

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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 sterilised before filling by means of the integrated H₂O₂ gas supply system.

All safety-relevant functions are constantly monitored electronically.

Model Features

Technical details:

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 H2O2 gas supply system with gas directly injected (DIS = direct injection system) below the fabric frame for an effective and stable sterilisation 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