Water is the one of the major commodities used by the pharmaceutical industry. It may present as an excipient, or used for reconstitution of products, during synthesis, during production of finished product, or as a cleaning agent for rinsing vessels, equipment and primary packing materials etc. There are many different grades of water used for pharmaceutical purposes.
Purified Water is used as an excipient in the production of non parenteral preparations and in other pharmaceutical applications, such as cleaning of certain equipment and non parenteral product-contact components. Unless otherwise specified, Purified Water is also to be used for all tests and assays for which water is indicated. Purified Water must meet the requirements for ionic and organic chemical purity and must be protected from microbial contamination.
Sterile Purified Water is Purified Water, packaged and rendered sterile. It is used in the preparation of dosage forms or in analytical applications requiring Purified Water where access to a validated Purified Water system is not practical, where only a relatively small quantity is needed, where sterile Purified Water is required, or where bulk packaged Purified Water is not suitably microbiologically controlled.
Pure Steam is also sometimes referred to as “clean steam”. It is used where the steam or its condensate would directly contact official articles or article-contact surfaces such as during their preparation, sterilization, or cleaning where no subsequent processing step is used to remove any code posited impurity residues.