WFI Design Standards

[andy_oohhh]

Hi, I am looking for WFI (Water-For-Injection) literature for design practices or standards. I am looking for pharmaceutical processing design standards in general. Does anyone know of any good books, standards, or documents on these topics? What resources do you reference when you are designing a new system?

 

[jari001]

The International Society of Pharmaceutical Engineers has a lot of good resources. If you look at companies that make WFI (e.g. Meco, Paul Mueller) generation equipment, they have good info. Standards for WFI are set by the regulatory agencies where the produce will be sold (e.g. FDA for the United States points to the US Pharmacopeia for WFI standards).

 

[EdStainless]

And then most of the equipment is designed and built to ASME BPE Codes.
Cleaning, sanitation, system passivation, point of use filtration, and so on are all issues to deal with.


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P.E. Metallurgy, consulting work welcomed