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.
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