WFI is water for parenteral use, prepared by distillation or reverse osmosis and

meeting certain standards for sterility and clarity; it may be specified as sterile if it
has been sterilized and as bacteriostatic if suitable antimicrobial agents have been
added.

Applications
Water for Injection (WFI) for Cell Culture can be used for a wide variety of cell culture and molecular biology
applications:

Diluting buffers

Cleaning or rinsing equipment

Hydrating dry powder media

Making solutions

Typical WFI uses:

Sterile Bulk API or BPC Preparation
Parenteral dosage forms
Final cleaning rinses for the above two application s

How is WFI made?

 In Europe, WFI can only be produced by distillation

USP allows for WFI production by RO or by distillation
JP allows for WFI production by RO, distillation or Ultra-Filtration
Two main still designs: Vapour Compression and Multi-Effect

General Design Principles

Sanitary diaphragm valves used throughout system
Single mechanical seal centrifugal pumps
Every line slopes to drain
Consider designing system for steaming
Recommend envelope gaskets (PTFE encapsulated EPDM)

What is WFI? WFI is highly purified water that contains less than 10 CFU/100 ml of Aerobic bacteria.
These waters should also have fewer than 500 ppb of total organic carbon, fewer than 0.25 EU/ml
endotoxins, and a conductivity of less than 1.3uS/cm @ 25 C.
Why is this important? Well, because as the name implies, WFI is the water, combined with active
ingredients used to make drugs that are injected into our bodies. It is also used a the final rinsing agent
for any component that comes in contact with the drug such as vials, ampules, caps and stoppers.
How do we make it? Through a series of steps aimed removing ionic and organic contaminants with the
final steps being distillation or reverse osmosis.
Once we make it, what do we do? Keep it hot and moving, use it or lose it. We store and transport WFI
using ultra high purity process equipment like highly polished tubing, diaphragm valves, sanitary
centrifugal pumps with single of double mechanical seals, and double sheet shell and tube heat
exchangers.
So what is done with WFI after it is produced to ensure the water stays at water for injections quality? It
either needs to be used quickly (usually same day) or put in a state that allows it to maintain its efficacy.
How do you make sure WFI stays as WFI? You need to minimize microbial growth. This is accomplished
by maintaining it at high temperatures and keeping it in motion. Normally WFI is kept at 90 degrees C
and recirculated through a distribution loop at a minimum velocity of 5 feet per second.