WFI

DEWADEST SC

Single-stage pressure column water distillation plant

Distillation plant for the production of sterile and pyrogenous free water out of fully deionized water suitable to produce Aqua ad injectabilia (WFI).

Compact unit at a favourable price destined for a capacity up to 50 l/h, electrically or steam heated.

Design and construction fully come up to GMP and FDA guidelines to obtain highest safety:

  • Pressurised operation, that means any kind of leakiness can be stated immediately so that penetration of germs is impossible
  • welding seams are located outside to avoid cross-contamination (as per FDA regulations)
  • premium materials – stainless steels in the product contacting area AISI 316L, otherwise AISI 304
  • effective demisting due to low steam velocity and cyclone effect
  • effective degassing of the distillate to achieve a conductance according to USP 24 with an In line measured value of < 1.3 µS/cm

Essential characteristics

  • compact design
  • fully automated operation
  • short heating-up time
  • no obligation for acceptance and surveillance
  • low consumption of energy and cooling water
  • clean steam production

DEWADEST MC / MCE

Multistage pressure column water distillation plant

Distillation plant for the production of WFI as per PharmEur and USP out of fully deionised water. Economically operating and reliable plants for a capacity as from 50 l/h. We are able to construct these plants in various ranges of capacity, e. g. 3 – 8 column plants, electrically or steam heated.

High processing quality and operation safety

All DEWADEST MC plants feature the opportunity of complete draining and complete self-sterilisation. Each product contacting part of the plant is made of stainless steel, material AISI 316L or higher with superior surface finish. All heat exchangers are performed as tube bundle heat exchangers. Pre heater, cooler and heat exchanger of the first column are furnished with a double tube sheet. Thereby, it is ensured that a mixture of clean and unclean water is impossible in case of water leakage in the connection between tube bundle and tube sheet.

Operation description

The distillation plant has 4 or more (max. 10) evaporating columns, the same count of pre-heaters and one pre heater/condensator and one cooler/condensator in horizontal position. All heat exchangers, which get charged with heating steam, cooling water or feed water, are tube bundle heat exchangers with a double tube sheet.

The heat exchanger with the 1. column gets charged with heating steam in the shell. The distillation plant gets supplied with pure water from the loop pipe. How to use the right amount of supply depends on the steam pressure. The feed water gets preheated up to nearly evaporation temperature, before it goes in the first evaporating column.

For this, the water gets lead to the horizontal pre heater and afterwards further to the pressure staged pre heater, which count is the same like the pressure columns. At the same time the preheating conduce to the cooling of the distillate. The distillate gets cooled down before it resign from the distillation plant. The cooler gets operated with softened water. When the distillate resigns the plant you can measure the temperature and conductivity.

All advantages at a glance

  • design and construction fully come up to GMP guidelines with effective demisting and double-tube sheet heat exchangers
  • low consumption of energy and cooling water
  • clean steam outlet for sterilisation purposes
  • fully automated operation if a level controller is placed in the storage tank
  • no moving parts, hence low noise operation, low abrasion, low maintenance costs
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