Producing Water for Injection (WFI) and Pure Steam

Introducing a raw material that is chemically and microbiologically extremely pure, often required in large quantities and has to be generated on-site, directly from available potable water; Water for Injection (WFI).

At BWT Africa, we develop systems that transform drinking water into BWT Purified Water, Water for Injections and Pure Steam, and which ensure safe storage and distribution. We also provide services that guarantee the safe and reliable operation of the system for decades ahead.

The European Pharmacopoeia, United States Pharmacopoeia (USP) and the Chinese Pharmacopoeia, have set out clear criteria for quality. 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.

With over 50 years’ experience and specialist expertise in meeting these stringent standards of quality, BWT is the world’s leading supplier of critical purified media. Varying degrees of purity, therefore, exist: Purified Water (or aqua purificata) and Water for Injections (or aqua ad iniectabilia).

WFI/Purified Water 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.
  • In medicinal applications, including, for example, insulin for diabetics, the manufacture of cardiac pacemakers or prostheses and artificial joints in the medical technology sector and life-​saving infusions.
  • As an essential element in all these areas; it is both a solvent and carrier medium in the end-​product and is also required for cleaning and rinsing packaging and production systems.

In hospitals, laboratories and homeopathic products were purified water/water for injection contributes to wellbeing and health, purity and safety have the highest priority.

What is Pure Steam?

Pure Steam is WFI in gas form and is utilised 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.

Why BWT Africa Is The Best Choice For You

When it comes to the production, storage and distribution of Water for Injection, BWT is without a doubt one of the best choices. At BWTA, we use compact, standardized systems which 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.

BWT Africa’s Distillation & Membrane Process

When it comes to the ideal solution for individual requirements; this would depend on many parameters such as consumption quantities and temperatures, the local situation, and media costs. The European Pharmacopoeia have since 2021 also permitted alternative membrane-​​based processes alongside distillation for generating Water for Injection.

Whichever process is selected to best suit your system, we will deliver safe systems and excellent quality with the right service over the life of the product.

Distillation Process

Distillation has become the process of choice for many operators when it comes to producing WFI. It is also a necessity for generating Pure Steam. The Ph. Eur. permitted only distillation until April 2017, while the USP has permitted the membrane process within the scope of the USP for a long time.

Membrane-Based WFI

Prior to 2017, distillation was the only permitted method in Ph. Eur. Discussions and investigations on alternative processes that could sufficiently demonstrate the required levels of safety carried on for decades, notably in USP. Finally in April 2017, alternative suitable production methods were permitted thanks to the “interim quality” of highly Purified Water was introduced until the change in the monographs (0169) for producing WFI.

Benefits of WFI from the Membrane Process

While distillation is the process of choice for many operators; the membrane process has many benefits:

  • It is extra secure and the cost-​effectively generated WFI can be used for all purposes. This quality level ensures safety and saves time through additional and earlier alarm and action limits.
  • It is environmentally friendly. Removal of the distillation process and downsizing the facilities results in huge energy savings. This is a good measure to combat global warming. Not using salt also helps our air and our water.
  • It is economical as there is less space required for generation and distribution. There’s a lower level of investment required.. Not to mention lower operating costs per m³/WFI whilst also offering a high degree of safety.

What We Use

In a risk-​based approach, BWT engineers have taken all applicable regulations into account when designing membrane-​based WFI systems.

This has resulted in two standardized systems: OSMOTRON WFI and LOOPO WFI. When a tank and loops are added, they have everything needed for producing safe, cost-​effective WFI between a potable water inlet and the point of use of systems technology.

Contact Us to Find Out Which Products You Need for Water for Injection and Pure Steam!