Water for Injection (WFI) quality water supports cell culture growth and biomanufacturing processes.
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.
HyPure WFI Quality Water undergoes extensive purification to meet or exceed the stringent specifications of the United States Pharmacopeia (USP).
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.
Certifications: Manufactured in cGMP (21 CFR 820) compliant and ISO9001 certified facilities.
Available in 500 ML PETE/PETG Bottles.
This lyophilized preparation is stable at room temperature when garded from light, but should be kept at -20°C for long term storage, preferably with dessicant. Upon reconstitution, the preparation is stable when stored at 2-8°C. For maximum stability, apportion the reconstituted preparation into working aliquots and store at -20°C. Avoid repeat freeze/thaw cycles.