STER-AHOL Details

STER-AHOL Details

Description

VAI manufactures an EPA registered denatured ethanol formulated to 70% with a small percentage of methyl alcohol and water for injection for use as a sanitizer and disinfectant in classified manufacturing and testing environments.  The STER-AHOL® WFI Formula product line offers a variety of sterile, ready to use, products that are available in multiple containers, and sizes.

Disinfectants and sanitizes cleanrooms and controlled areas such as those used in healthcare institutions, biopharmaceutical, pharmaceutical, medical device, and diagnostic manufacturing facilities.  STER-AHOL WFI Formula can be used for the decontamination of items such as gloves, surfaces, carts, counter tops, process lines, aseptic connections, and many other applications that require the use of a sterile alcohol solution.

Products are completely tested according to USP specifications and are delivered with lot specific documentation. STER-AHOL WFI Formula is available in multiple container sizes including gallons, 16 oz triggers, and aerosol.

Patents: www.sterile.com/patents

Additional Information

  • Quality and Manufacturing
    • Filled in ISO 5 (Grade A/B, Former Class 100)
    • Manufactured with USP Water For Injection
    • Filtered at 0.2 microns
    • Gamma irradiated to a sterility assurance level of 10-6
    • Sterility tested according to current USP compendium
    • Assayed according to current USP compendium
    • Completely traceable from start to finish
    • Completely validated for sterility and shelf life
  • Features and Benefits
    • Packaged quadruple bagged in the ABCD Clean Room Introduction System™
    • Delivered with a lot specific Certificate of Analysis, Certificate of Irradiation, LAL and Certificate of Sterility
    • Ready to use
    • STER-AHOL® WFI Formula is an EPA registered sanitizer and disinfectant
  • Product Uses
    • Applications that require a sterile ethanol solution made with USP Water for Injection
    • Non-food contact, hard non-porous and inanimate surfaces
    • Aseptic filling and gowning rooms
    • General manufacturing areas and laboratories
    • Machinery, tools, tables, counters, laminar flow benches, floors, walls and carts
    • Shelves made of hard non-porous materials, such as: glass, plastic, vinyl, chrome, and stainless steel
    • Compatible with most hard surface materials
    • Gloves
  • Technical Documents

    Technical Reports

    STER-AHOL-WFI_VL-109-1_10-Nov-2010.pdf

    MSDS/SDS

    STER-AHOL-WFI-Formula-Aerosol-VEL-109A-SDS-North-American-English-NAE-1.pdf
    Translations available in the following languages:

    STER-AHOL_WFI_FORMULA_Non-Aerosol-VEL-109NA-SDS-North-American-English-NAE-1.pdf
    Translations available in the following languages:

    Leaflets

    Ster-Ahol-Leaflet.pdf