VAI WFI QUALITY WATER Details

VAI WFI QUALITY WATER Details

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

  • Quality and Manufacturing
    • 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”
  • Features and Benefits
    • 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
  • Product Uses
    • Chemical formulation, disinfectant dilution
    • Lubricating
    • Rinsing, cleaning
  • Technical Documents

    SDS/SB258

    VAI-WFI-Quality-Water-Non-Aerosol_SDS-VEL-149-North-American-English-NAE_v3.1.pdf
    Translations available in the following languages:

    VAI-WFI-QUALITY-WATER-AEROSOL_SDS-VEL-028-A-North-American-English-NAE_v5.0-1.pdf
    Translations available in the following languages:

    Technical Reports

    VAI_WFI_Quality_Water_TDF_11Nov2019.pdf