Letzner Pharmawasseraufbereitung

Single Effect Still

Main Features

  • Extremely suitable and economical to produce WFI according Ph. Eur. and USP in cases OF WFI consumption less than 200 m3 a year
  • Degasification up-stream of the system
  • Integrated FDA/USP compliant pure steam generator
  • Full factory acceptability testing (FAT) documentation

Quality features

  • Column is pressurised during stand-by. The degasifying effect in front of the still allows operation of the condenser at temperatures of > 110 °C providing filling of the storage vessels to higher levels.
  • Draining condenser: Fully automatic draining of condenser during shutdown (FDA requirement).
  • Droplet separation by centricyclone separator and by gravity: 4-5 Log pyrogen reduction verified by FAT Challengetest.
  • Sanitary system design: Includes draining of degasifire, column and pump.
  • Pre-pressure rising station and degasifying column: Effective elimination of non condensable gas to guarantee the conductivity according to USP standards.
  • Level control of effect: Flooding of effects (malfunction) will be detected according to USP supplement.

Construction features

  • Pure steam generator: The column can also be used as a pure steam generator, which is able to produce pure steam 24 hours a day, independent from WFI production. Independent from the WFI production rate the first column can be oversized if additional capacity of pure steam is needed.
  • Extension of capacity: For higher production rates additional effects can be installed. Energy and cooling water costs are reduced.
  • Thermosyphon- principle: The construction of the thermosyphon generator with its effective natural circulation has thermodynamic advantages.
  • Headroom: Compared to standard thin film evaporator heatexchangers, the Letzner style head-ROOM has been reduced.
  • Double tubesheet heatexchangers: The tubes are welded in the head-plates, thereby lowering the 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 the installation room.
  • Energy utilization: Preheating of feed-water by blow down heatexchanger, condensator and heat exchanger between the effects.
  • Stainless steel controlbox and frame
  • Option: electropolished

Control system and visualization

  • PLC- Siemens S7
  • Visualization system with data recording for documentation on PC
  • Telemaintenance function
  • Option: busconnection

Qualification and validation

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