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WFI

WFI is water for parenteral use that meets standards for sterility and clarity. It is prepared through distillation or reverse osmosis and may be specified as sterile if sterilized or bacteriostatic if antimicrobial agents are added. WFI is highly purified water containing less than 10 CFU/100 ml of bacteria and is important because it is used to make drugs injected into bodies. It is also used for final rinsing of drug vials and containers. WFI is made through a process removing ionic and organic contaminants, with the final steps being distillation or reverse osmosis. To maintain its quality, WFI must be kept at high temperatures and in motion to minimize microbial growth.

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151 views3 pages

WFI

WFI is water for parenteral use that meets standards for sterility and clarity. It is prepared through distillation or reverse osmosis and may be specified as sterile if sterilized or bacteriostatic if antimicrobial agents are added. WFI is highly purified water containing less than 10 CFU/100 ml of bacteria and is important because it is used to make drugs injected into bodies. It is also used for final rinsing of drug vials and containers. WFI is made through a process removing ionic and organic contaminants, with the final steps being distillation or reverse osmosis. To maintain its quality, WFI must be kept at high temperatures and in motion to minimize microbial growth.

Uploaded by

Mohamad Syamil
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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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.

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