Utilities and Building Systems

Water systems are expected to be demonstrated to be suitable for their intended uses. At a minimum, water is required to meet the World Health Organization requirements for drinking (potable) water. Processing steps such as isolation and purification will require purified water as outlined in USP 23 (2), pharmaceutical grade water. Validation of water systems is required for all product contact water systems. We 

Gases used in final processing steps will also require validation and GMP compliance. These gases, such as nitrogen, will be required to pass through filtration systems to remove any microbes that might be in the gas stream. 

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