HyClone’s WFI system employs a state-of-the-art purification train that begins with high quality water sources. Water undergoes multimedia filtration, mineral reduction, reverse osmosis, continuous deionization, UV light treatment, and distillation. HyClone’s validated system is designed to meet all manufacturing processes and testing requirements of the current USP monograph for WFI. Routine monitoring and sampling plans include the following tests and specifications:

Additional tests performed on HyClone’s packaged HyPure™ WFI Quality Water routinely include those for chloride, sulfate, calcium, carbon dioxideand oxidizable substances.

Large capacity requirements for media, buffers, salts, or other process liquids that utilize water from HyClone’s WFI system are routinely produced in lots sizes up to 10,000 L. Current expansions to these systems will enable HyClone to continue to meet the demanding needs of today’s large-scale biopharm manufacturers.