Description
VAI® manufactures a USP grade bulk Water for Injection (WFI), VAI® WFI Quality Water, that is ready-to-use and can be used throughout any facility for chemical formulation, disinfectant dilution, cleaning, rinsing, and lubrication. VAI’s WFI Quality Water is produced from a 6 effect distilled water system that is validated, routinely monitored, and passes all USP monograph requirements for “Water for Injection”.
VAI WFI Quality Water is processed to comply with the standards required by the pharmaceutical, biotechnology, medical device, and healthcare industries. VAI WFI Quality Water is an innovative solution for GMP facilities that demand the use of a sterile WFI quality water in their daily operations but do not have it readily available on site.
VAI WFI QUALITY WATER IS NOT FOR HUMAN OR ANIMAL INJECTION, DIAGNOSTIC, OR THERAPEUTIC USE.
Patents: www.sterile.com/patents
Additional Information
Filled in an ISO 5 (Grade A/B, Former Class 100) operation
Filtered at 0.2 microns
Components are air washed with 0.2 micron filtered air before assembly
Gamma irradiated at a 10-6 SAL
Lot sterility tested according to current USP compendium
Lot tested for endotoxins
Completely traceable from start to finish
Completely validated for sterility and shelf life
Produced from a validated 6 effect distilled water system
Passes all USP monograph requirements for “Water for Injection”
Each sterile container is double bagged in easy tear packaging
Quadruple bagged in the ABCD Cleanroom Introduction System®
Individually labeled with lot number and expiration
Delivered with lot specific Certificate of Analysis, Certificate of Irradiation, and Certificate of Sterility tested to current USP compendium
For use on a multitude of surfaces
Lubricates for continuous and effortless manufacturing
Meets the needs for USP grade WFI when required in cleanroom operations
Ideal for operations that do not have USP grade WFI readily available
Chemical formulation, disinfectant dilution
Lubricating
Rinsing, cleaning
SDS/SB258
VAI-WFI-Quality-Water-Non-Aerosol_SDS-VEL-149-North-American-English-NAE_v3.1.pdf
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Technical Reports
VAI_WFI_Quality_Water_TDF_11Nov2019.pdf
