Support cell culture growth and biomanufacturing processes with Water for Injection (WFI) quality water
Meets stringent USP specifications
Manufactured in ISO 9001 certified facility
Lot-specific certificate of analysis (CoA) for each lot of water produced
Intended for further manufacturing or research use
Not for diagnostic or therapeutic use
HyClone HyPure WFI Quality Water undergoes extensive purification to meet or exceed the stringent specifications of United States Pharmacopeia (USP)
Water for injection (WFI) is produced in ISO 9001 certified facilities to ensure a high quality product
HyPure WFI Quality Water meets the following criteria: Must be produced from a validated water purification system that meets or exceeds current USP requirements for HyPure WFI Quality Water
Must have a quality assurance monitoring system that ensures continuous compliance and incorporates system test and action limits
Must meet all applicable chemical, purity, and other acceptance criteria as outlined in the current USP for both system and packaged water
Must include a lot-specific CoA for each lot of water produced, listing both acceptance criteria and actual test results
Actual test results on a CoA are not taken from system samples, but must be from actual packaged samples of the given lot.