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Production, storage, and distribution of Water for Injection.

Extremely stringent requirements apply to WFI quality worldwide, defined by the pharmacopoeias. BWT is the best choice when it comes to the production, storage, and distribution of Water for Injection.
Discover WFI quality

Water for injec­tion

WFI

Water for Injec­tion (WFI) is an impor­tant raw mate­rial. It is often required in large quan­ti­ties and there­fore has to be gener­ated on-site, directly from the avail­able potable water. The Euro­pean Phar­ma­copoeia, as well as the United States Phar­ma­copoeia and the Chinese Phar­ma­copoeia, set out clear quality criteria. Water purity is clearly defined with threshold values for the micro­bi­o­log­ical load in the form of colony-forming units, conduc­tivity and quan­tity of organic carbon.

WFI is used:

  • As a solu­tion or thinner for substances and prepa­ra­tions for parenteral admin­is­tra­tion
  • In bulk when making parenteral or ophthalmic prod­ucts
  • For final rinsing of recep­ta­cles, such as primary pack­aging and manu­fac­turing of these prod­ucts

Pure Steam is gaseous WFI and is used for ster­il­iza­tion, drying, and humid­i­fi­ca­tion. The degree of steam satu­ra­tion, dryness, and quan­tity of non-condens­able gases must be deter­mined for the indi­vidual appli­ca­tion or the applic­able regu­la­tions set out in EN 285.

Pharma
Pharma

Pharmacopoeia requirements

The European Pharmacopoeia, the United States Pharmacopoeia, and the Chinese Pharmacopoeia at a glance
USP Ph. Eur. ChP
TOC ppm C ≤ 0.50 ≤ 0.50 Same as Ph. Eur.
Conduc­tivity µS/cm ≤ 1.3 (25°C) ≤ 1.1 (20°C) Same as Ph. Eur.
Nitrate (NO3) - ≤ 0.2 ppm ≤ 0.000006%
Aerobic bacteria CFU/100 ml ≤ 10 ≤ 10 Same as Ph. Eur.
Bacte­rial Endo­toxins /ml ≤ 0.25 EU ≤ 0.25 IU ≤ 0.25 EUI

Great reasons to trust ultra-pure media and BWT

Distillation or membrane process? With BWT you have the free choice.

Since early 2017, the Euro­pean Phar­ma­copoeia has also permitted alter­na­tive membrane-​based processes along­side distil­la­tion for gener­ating Water for Injec­tion.

The best solu­tion for indi­vidual require­ments depends on many para­me­ters such as consump­tion quan­ti­ties and temper­a­tures, the local situ­a­tion, and media costs.

Regard­less of the process, BWT delivers safe systems and excel­lent quality with the right service over the life of the product.


Find out more
Osmotron or Multistil Osmotron or Multistil

Products for Water for Injection and Pure Steam

BWT is the best choice when it comes to the gener­a­tion, storage, and distri­b­u­tion of Water for Injec­tion. Compact, stan­dard­ized systems combine all neces­sary process steps and tech­nolo­gies to reli­ably ensure the highest levels of safety within the process.

Systems are fully tested (FAT), preval­i­dated, and docu­mented prior to delivery.

Comparing costs of WFI generation

The costs per m³ WFI depend on many factors: Unit design is heavily influenced by the individual consumption profile and required WFI temperature, whilst media costs also vary widely. BWT experts will consult you finding the right sizing and generation process. For example the following costs are incurred for potable water until it comes to the WFI tank inlet:

Distillation unit, 8 columns Membrane unit, 2xRO-EDI/UF
3 m³/h WFI* €13.77/m³ €8.55/m³
9 m³/h WFI* €12.28/m³ €5.84/m³
WFI temperature (inlet tank) >85°C 10...20°C


*Assumptions: Production 16 hrs/day; 5 days/week; 52 weeks/year

BWT will gladly advise you on your individual requirements whilst taking your situation into account. Simply reach out to your BWT contact. Together, we'll find the perfect solution.

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AQU@Service for WFI System

Maximum safety, reliability, and value retention in critical production applications are achieved via quality systems, preventative service, and intelligent spare parts management.

The planned, documented AQU@Service for distillation units with BWT means users are on the safe side with sensor calibration and replacement of all seals and membranes in operation, as well as in audits and inspections.
Discover AQU@Services