Construction of membrane units

Starting with customers ideas, needs and requirements we develop the process, design the unit and build, test, deliver, install, train and service.

GMP microfiltration unit for parenterals

GMP-microfiltration for parenterals

Details:

  • sanitary design, perfect emptying
  • very precise measurement and controll
  • inner surfaces Ra 0.6 electropolished
  • outer surfaces Ra 0.8
  • complete manufacturing documentation (welder certificates, material certificates, isometrie, orbital welding parameters)
  • material certificates EN10204 3.1B
  • FDA-conformity 21 CFR177.2600 / 21 CFR 177.1550. for seals and flexible tubes
  • pump greas USD-H1 conform
  • DQ, IQ, OQ, FAT documentation
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