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VAI-WFI Quality Water™

VAI®'s WFI Quality Water is a sterile, USP grade Water for Injection (WFI) that is processed to comply with the standards required by the pharmaceutical, biotechnology, medical device, and healthcare industries. VAI WFI Quality Water is produced from a Six-Effect distillation water system that is validated, routinely monitored, and passes all USP monograph requirements for "Water for Injection". The product is manufactured in a Grade A, aseptic filling operation, filtered at 0.2 microns, quadruple bagged and gamma irradiated at a validated 10-6 SAL dose to render the product sterile.

VAI Quality Water can be used throughout the operations for chemical formulations, disinfectant dilution, cleaning, rinsing and lubrication. VAI 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 or require it for an interim period while in-house systems are being serviced, passivated or repaired.

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VAI WFI Quality Water

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  • Filtrado a 0.2 micrones
  • Etiquetado individualmente con número de lote y caducidad
  • Quadruple Bagged. Each 16 ounce (473 mL) with attached trigger sprayer, one gallon (3.78L) and 2 gallon (7.56 L) sterile container are double bagged in easy tear packaging and the contents of the case double bagged creating a quaduple bagged product. The 55 gallon (200 L) container is double bag packaged and skidded.
  • The 55 gallon (200L) is available in two versions. Version One is filled into a virgin, precleaned PVC drum. Version Two is filled into a sterile bag located inside a PVC drum. Each container has specific applications. Contact VAI for uses.
  • Quadruple bagged in the ABCD Cleanroom Introduction System®. Each sterile container is double bagged in easy tear packaging and the contents of the case double bagged.One Layer is removed in Grade (A-D) classification resulting in no spray down.
  • Gamma Irradiated by a validated dose at a 10-6 SAL
  • Delivered with lot specific analytical, irradiation, LAL and sterility (USP <71> data tested to current USP compendium
  • Completely lot traceable from start to finish
  • Completely validated for sterility and 2 year shelf life
  • Fabricado de acuerdo con las cGMP.
  • Endotoxing levels, per USP, <0.25 EU/mL. Manufactured within a closed system where endotoxin levels are controlled
  • VAI-WFI® 55 gallon (200L) container is packaged and delived with all required dispnsing hoses atop the container and inside the first sterile bag for easy dispensing.
  • Los componentes se lavan con aire filtrado de 0.2 micrones antes del ensamblaje
  • Filled in an ISO 5 cleanroom (Grade A)
  • Filled into 16 ounce (473 mL), one gallon (3.78L) and 2 gallon (7.56 L) containers and 55 gallon (200L) drums.
  • 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 ready-to-use and can be used throughout any facility for chemical formulation, disinfectant dilution, cleaning, rinsing, and lubrication. Lubrication of moving parts, process lines, and conveyors is essential for continuous and effortless manufacturing.
  • VAI-WFI® Quality Water can bridge the gap during shutdown period where maintenance on in-house WFI systems may be required.
  • Quadruple bagging (ABCD Cleanroom Introduction System®) assure elimination of outer bag spray down as one layer is removed in each classification.
  • Delivered with lot specific analytical, irradiation, and sterility (USP <71> data tested to current USP compendium

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