STERI-BUFFER Details

STERI-BUFFER Details

Description

VAI manufactures a phosphate buffer solution that is processed to comply with the standards required by pharmaceutical, biotechnology, and medical device industries.  STERI-BUFFER® is a sterile phosphate buffered to a pH of 7.2 + 0.2 made with USP Water for Injection.  STERI-BUFFER is used as a rinse agent for lab testing such as bioburden testing and AET Testing.

STERI-BUFFER is filled in an easy open and close, wide mouth bottle and assured sterile every single time.  Each bottle contains a “no-tamper strip” that is broken once the bottle has been opened.

STERI-BUFFER is completely lot traceable and delivered with lot specific documentation.

Patents: www.sterile.com/patents

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Additional Information

  • Quality and Manufacturing
    • Filled in ISO 5 (Grade A/B, Former Class 100)
    • Filtered at 0.2 microns
    • Gamma irradiated to a sterility assurance level of 10-6
    • Sterility tested 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, and Certificate of Sterility
  • Product Uses
    • Pharmaceutical microbial limits testing
    • Rinse solution
    • Bioburden testing
    • AET testing

     

  • Technical Documents

    MSDS/SDS

    STERI-BUFFER-90-99_2002-SB9099-01-SDS-North-American-English-NAE-1.pdf
    Translations available in the following languages:

    Technical Reports

    STERI-BUFFER_sb9099_12-Jun-2009.pdf