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Water for biopharmaceutical processing

Water represents one of the most important raw materials used in biopharmaceutical manufacture. It is used as a basic ingredient of fermentation media, and in the manufacture of buffers used throughout product extraction and purification. It represents the solvent in which biopharmaceutical products sold in liquid form are dissolved, and in which freeze-dried biopharmaceuticals will be reconstituted immediately prior to use. It is also used for ancillary processes, such as the cleaning of equipment, piping and product-holding tanks. It is additionally used to clean/rinse the vials into which the final product is filled. [Pg.104]

It has been estimated that up to 30 000 litres of water is required to support the production of 1 kg of a recombinant biopharmaceutical produced in a microbial system. It is not surprising, therefore, that the generation of water of suitable purity for processing is central to the [Pg.104]


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