Letzner Pharmawasseraufbereitung

One-Pass RO-System/EDI

Quality features

  • Sanitary design of pre-treatment RO-system and EDI: Biofilms will be avoided and microbiological requirements will be maintained during shutdown and at elevated room temperatures.
  • All stainless steel Sanitary system design: Sanitary construction throughout using diaphragm valves, sanitary connections and orbital weldings.
  • Quality controlled output: Only water meeting the Purified Water Specification is feet into the process water storage vessel.
  • Cleaning and preservation by Letzner CO2 patented process: During shutdown the system is pressurised by CO2. The membranes and the EDI´concentrate channels will be cleaned and microbiological growth is prevented.
  • Sanitary type Luer valves are used for sampling.
  • Pharmaceutical grade construction of EDI meets FDA cGMP compliance and comes with certification.

Construction features

  • Proven submersible pump technology: Submersible pumps are up to 85% quieter than those used in traditional RO- systems. The pump motor is cooled by process feed water.
  • Stainless steel pressures vessels are of 316L stainless steel with Sanitary type end caps. Vessels corne with Factory Acceptability Test Certification.
  • Integrity test of individual RO- cartridges are performed and documented.
  • The system is “Soft“ start for minimal mechanical stress of the RO-cartridges.
  • All product water piping is orbital welded (³ 95% of all welds). Boroscopic documentation and certification of the welds is provided.
  • Hardness is controlled with carbon dioxide and / or with high molecular weight sequestrant (descalent) to prevent scaling.
  • Depending on the quality of the feed water softeners may be used to prevent scaling in the EDI concentrate channel.
  • Plant capability can be increased 50 to 100% by adding additional pressure vessels and EDI stacks.
  • During shutdown the system will be cleaned with the permeate high purity water and CO2.

Control system and visualization

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

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)
  • Factory Acceptably Testing (FAT) and pre-qualification in our facility

Reduced Operating costs

  • The automatic cleaning with CO2 in concert with an RO-recovery of 85-90% (concen-trate recycling) and the EDI concentrate recycling reduce running costs by as much as 45%.