STERI-BUFFER Details

STERI-BUFFER Details

Description

VAI® manufactures two sterile, disposable, sodium phosphate buffer solutions, STERI-BUFFER® 90 & 99, that are assayed to current USP Standards (Bufferfield’s Buffer) and buffered to a pH of 7.2 ± 0.2. STERI-BUFFER Products are available in either a 90 mL or 99 mL fill level.

STERI-BUFFER Products are processed to comply with the standards required by pharmaceutical, biotechnology, and medical device industries. STERI-BUFFER Products have been developed for use as a buffer solution and diluent in lab testing such a bioburden testing, pharmaceutical microbial limits testing, and AET testing and as a rinsing agent.

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
    • Formulated with USP Water for Injection (0.25 EU/mL)
    • 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
    • Completely traceable from start to finish
    • Completely validated for sterility and shelf life
  • Features and Benefits
    • • Each sterile container is bagged two per bag in easy tear bags and packaged in two case liners for easy transport to the core
    • Individually labeled with lot number and expiration
    • Delivered with lot specific Certificate of Analysis, Certificate of Sterility, and Certificate of Irradiation tested to current USP compendium
    • Available in two fill levels, 90 mL or 99 mL to fit your operation’s needs
    • Assayed to current USP Standards (Butterfield’s Buffer)
    • Buffered to a pH of 7.2 ± 0.2
    • Each bottle has a “no tamper strip” that breaks once the bottle has been opened
    • Disposable
    • Odorless
  • Product Uses
    • Rinsing agent
    • Buffer solution in laboratory testing including bioburden testing, pharmaceutical microbial limits testing, and AET testing
  • Technical Documents

    SDS/SB258

    STERI-BUFFER-SB258.pdf

    STERI-BUFFER-90-99_SDS-2002-SB9099-01-North-American-English-NAE_v3.0-1.pdf
    Translations available in the following languages:

    Technical Reports

    STERI-BUFFER_9099_TDF_28Sep2017.pdf