Description
VAI WFI-quality sterile pharmaceutical grade water is an innovative solution for GMP facilities that demand the use of a sterile water and WFI quality water in their daily operations. 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’s WFI Quality Water 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 is not for human or animal injection, diagnostic, or therapeutic use.
Before filling, all bottles are blown and cleaned with 0.2 microns filtered air, all quality water is filtered at 0.2 microns in an ISO 5 Class 100 environment, and the finished product is subsequently gamma irradiated at 10-6 SAL. Available container sizes include 16 oz trigger spray, 1 gallon, 2 gallons, 200 liter drums, and an 11 oz aerosol spray can. Each lot of VAI’s WFI Quality Water is assayed and sterility tested according to the current USP Compendium and tested for endotoxin levels, those of which consistently fall below 0.03 EU/mL. VAI WFI quality water has been thoroughly validated for sterility and shelf life and is completely traceable from start to finish. The aerosol spray can precipitate in a broad yet fine droplet spray that does not aspirate the room’s air. Non-aspiration ensures that the master reservoir of WFI-quality water remains sterile from the first to the last. Aerosol spray cans are delivered with a nozzle extension that is ideal for use in harder-to-reach locations or when lubricating intricate machinery parts.
- Gamma irradiated at a 10-6 SAL
- Each container is double bagged, packaged sterile and available in our ABCD Cleanroom Introduction SystemTM
- Completely lot traceable and has been validated for sterility and shelf life
- Assayed according to the current USP Compendium
- Filtered at 0.2 microns
- Delivered each time with lot-specific Certificate of Analysis, Certificate of Sterility, Certificate of Irradiation and safety material
- Sterility tested according to the current USP Compendium
