Letzner Pharmawasseraufbereitung

Pure Steam Generator

Quality features

  • Droplet separation by centricyclon separator and by gravity: 4-5 Log pyrogen reduction demonstrated by validation Challengetest.
  • Sanitary system design: For example draining of degasifire, column and pump.
  • The conductivity of the pure steam is continuously monitored.
  • Pre-pressure rising station and degasifying column: Effective elimination of non condensable gas to guarantee the conductivity according USP.
  • Level control of effect: Flooding of effects (malfunction) will be detected according USP supplement.

Construction features

  • WFI production: The pure steam generator can be enlarged by adding additional columns to build up a multi effect still.
  • Extension of capacity: For higher productions rates additional heatexchangers can be installed.
  • Thermosyphon-princip: The construction of the thermosyphon generator with its effective natural circulation has thermodynamic advantages.
  • Headspace: Compared to heatexchangers with the thin film evaporator the headspace is reduced.
  • Double tubesheet heatexchangers: The tubes are welded in the headplate, which reduces risk of corrosion.
  • Sanitary design: Includes double tube-sheet heatexchangers, diaphragm valves, sensor with sanitary connections and orbital welds. All surfaces in contact with product are 316L, stainless steel and have sanitary connections and seals.
  • Custom designed: The dimensions can be adapted to fit the utilities room.
  • Energy utilization: Pre-heating of feed-water by blow down heatexchanger.
  • Stainless steel controlbox and frame
  • Option: electropolished

Control system and visualization

  • Storage programmable control system Siemens S7
  • Visualization system with data recording for documentation on PC
  • Telemaintenance function
  • Option: busconnenction

Qualification and validation

  • Design qualification (DQ)
  • Welding documentation
  • Boroscopic documentation of welds
  • Delta ferrite control
  • Installation qualification (IQ)
  • Performance qualification (PQ) with Standard Operating Procedures (SOP`s)
  • Endotoxin Challengetest
  • Factory Acceptably Testing (FAT) and pre-qualification in our facility