Water For Injection (WFI)

MULTIPLE EFFECT DISTILLATION UNIT

Multiple Effect Distillation Unit

ELETTRACQUA multiple effects distillation units consist of different evaporation sections each provided of liquid disengaging sections and a final condensing units.

In order to increase the energy savings, an additional DTS sanitary heat exchanger is installed to recover heat from the steam condensate to the first effect, transferring sensible heat to the feed water.

The column of each effect operates in series, only the first one Is heated by plant steam.

The steam produced from each effect is used to feed the downstream effect in sequence of steps.

CYCLONE
Cyclone
THE STEAM SEPARATION SYSTEM IS THE HEART OF THE SYSTEM BEING INSTALLED INSIDE THE EVAPORATION COLUMN DIRECTLY IN CONTACT WITH THE PURE STEAM PRO-DUCED BY THE SEPARATION OF THE WATER DROPLETS FROM THE PURE STEAM.

ELETTRACQUA new pure steam generators and distillation units are all equipped of cyclone steam separation systems instead of the demister traditionally used for this purpose.

Two basic principles are involved in the steam separation by Cyclone System

  • High Steam Speed creating centrifugal forces that separate any entrained water particles and throw them to the outer wall of separator to drain.
  • Double 180 turns: the pure steam flow direction is forced to double 180° turns inducing gravity separation of larger water droplets

The pharmaceutical customers pay lots attention to the materials and surface finishing, the cy-clone system, that is the heap of the system is the only device designed to meet all the material and finishing requirements, including ferrite tests. The cyclone separation system for its nature is a fully hygienic device.

ELETTRACQUA WA units and PURE STEAM GENERATORS are equipped with Cyclone separa-don system in all the evaporation columns

FEATURES and CONSTRUCTION

ELETTRACOUA ELETTRA LP-ps WFI units are designed in compliance to the the cGMP for the production of pure steam meeting or exceeding the product quality requirements stated in the current USP, EU and Japan Pharmacopoeias.

  • DTS Heat exchanger AISI 316L - standard surface finishing of the equipment Is < 0,6 urn RA.
  • ASME SPE piping and fittings 0.51 pm / 20 pinch Ra SF1 (higher finishings are available as options)
  • Flow regulation valves on water supply and Industrial steam supply
  • 4-20 mA level transmitter for the continuous measurements of the water inside the evaporation column
  • Cyclone system separator to remove the droplets from the pure steam
  • Orbital Welding of the piping wherever Is possible
  • AISI 304 Frame
  • 4-20 mA temperature Transmitters on the each distillation column.
  • Control System: PLC / HMI (all the PLC brands are available).
  • Standard design and manufacturing code PED Pressure equipment Directive 97/23/EC
  • Available option Design and manufacturing code ASME U Stamp
Operation Features


High efficiency:

The Maximum energy efficiency is obtained recovering the condensate steam from the first effect heating the feed water through a DTS Heat exchanger.

Widest operation range:

The Automatic Water level control in all the evaporation columns. the adjustment on the incoming plant steam and the design of the colund that never stop the production for flooding gives the possibility to work in a wider production operation range according to the WEI storage tank level.

Single effect level regulation:

Each effect is provided of a dedicated 4-20 mA level trans miner and an automatic flow control valve for a better wa-ter level adjustment inside the effects during transient in the steam pressure to the first effects.

Operation Safety and Long Life Time:

A stainless Steel expantion joint is installed to avoid dif-ferential expantion rates that could cause stress cracking.

Easy and cheap maintenance:

Compared to therrnocopression WA units the Multiple ef-fects Distillation systems have a Lower maintenance since there isn't no mechanical moving parts.

DESIGN GUIDELINES

  • UNI EN 285.
  • HIM 2031.
  • HTM 2010.
  • FDA • Guide to inspection of high purity water system.
  • Guide for Validation of Automated Systems in Pharmaceutical Manufacture.
  • European Commission • Good Manufacturing Practices.
  • ASME BPE • 2007 Bioprocessing Equipment.
  • ISPE Guidelines: Water and steam systems

UTILITIES REQUIREMENTS

ELECTRICAL:
400 VAC. 50.60 Hz, 3-Phase

INDUSTRIAL STEAM:
97-100% Saturated Steam
From 3,5 to 8 barg design possibilities

FEED WATER:
Quality: Purified Water
Conductivity: meeting PW requirements

INSTRUMENT AIR:
6.8 berg - dry , oil free

COOLING WATER:
Temperature: < 15°C
Hardness < 10 °F (100 ppm CaCO3)

Note: Other design options are available for different utilities supply.

STANDARDS AND CERTIFICATES

ELETTRACQUA products are designed and and manufactured to meet applicable sections of the fol-lowing EUROPEAN Community (CE) certifications:

  • PED Pressure equipment Directive 97/23/EC
  • ASME U STAMP
  • HTM 2010.
  • Machine Directive: 2006/42/CE
  • Electro magnetic compatibility 2004/108/CE
  • Low voltage directive: 2006/95/CE

Other countries certification and standards are avail-able as options.

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