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Anonymous Poster

Purified water for pharmaceutical use

04/03/2008 1:50 AM

From Baudouin Houtart IPDS Belgium

What are the recommended methods to produce purified water for pharmaceutical use and what are the related guidelines or standards related to that topic? Thank you

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#1

Re: Purified water for pharmaceutical use

04/03/2008 10:26 PM

The recommended method will depend on the volume and level of purity required. Higher volume and lower purity levels can be produced using reverse osmosis. Lower volume and higher purity is produced using deionization. For the largest volume and highest level of purity, both methods are combined.

There are several different standards depending on what country you are in.

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#2

Re: Purified water for pharmaceutical use

04/07/2008 4:01 PM

With all things it depends how clean and how much.

Reverse osmosis is most common, but can only get to a certain level of purtiy.

Ion exchange beds are useful for making deionized water, but you will need to do some filtration and purification to remove bacteria and other micro organisms.

Distallation is also used for high purity applications such as water for injecton, but again some clean up is required for the removal pyrogens (remanents of cell bodies that might carry over in the still which cause an immune responce when injected.)

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#3

Re: Purified water for pharmaceutical use

05/27/2008 1:15 PM

Dear Guest, in addition to the above responses which seem fair, if you refer to the Pharmacopoeias (eg US Pharmacopeia,European Pharmacopoeia,or Japanese Pharmacopeia ) then you will get the specific chemical & micro requirements along with suggested methods of production.

In general the preferred method for WFI is distillation, however two stage RO can also be used (I am not aware of any company that uses two stage RO for the generation of WFI due to the inherent micro issues that are associated with RO). The benefit of distillation is that the water is generated at high temperatures and can be maintained at high temperatures in order to maintain the micro standards.

Hope this helps.

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#4

Re: Purified water for pharmaceutical use

12/27/2008 7:06 PM

THe question you have asked is very broad. UV purification, reverse osmosis, de-I water.

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