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  • Millipore Equinox Steritest System

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    zizou123
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    The document discusses sterility testing using the Millipore Equinox Steritest System. It notes that sterility is defined as a complete absence of viable microorganisms, but sterility tests have statistical limitations in detecting contamination. The Millipore system allows for testing of injectables and sterile preparations by flowing prepared solutions through a microporous membrane filter to determine the presence of microorganisms. Common sterilization methods mentioned include steam, dry heat, gas, and radiation sterilization as well as filtration.

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    Sterilization

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    The document discusses sterility testing using the Millipore Equinox Steritest System. It notes that sterility is defined as a complete absence of viable microorganisms, but sterility tests have statistical limitations in detecting contamination. The Millipore system allows for testing of injectables and sterile preparations by flowing prepared solutions through a microporous membrane filter to determine the presence of microorganisms. Common sterilization methods mentioned include steam, dry heat, gas, and radiation sterilization as well as filtration.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PPTX, PDF, TXT or read online from Scribd
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    9 views5 pages

    Millipore Equinox Steritest System

    Uploaded by

    zizou123
    The document discusses sterility testing using the Millipore Equinox Steritest System. It notes that sterility is defined as a complete absence of viable microorganisms, but sterility tests have statistical limitations in detecting contamination. The Millipore system allows for testing of injectables and sterile preparations by flowing prepared solutions through a microporous membrane filter to determine the presence of microorganisms. Common sterilization methods mentioned include steam, dry heat, gas, and radiation sterilization as well as filtration.

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    Attribution Non-Commercial (BY-NC)
    Download as PPTX, PDF, TXT or read online from Scribd
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    Millipore Equinox Steritest System

    Sterility:
    A specimen said to be sterile only when there is complete absence of viable microorganisms from it.
    However, this absolute definition cannot currently be applied to an entire lot of finished compendial articles because of limitations in testing. sterility test suffers from significant statistical limitations and this contributes to the low probability of detecting anything less than gross contamination. However, these limitations can be reduced considerably by performance of the test under conditions that optimize the recovery of micro-organisms.

    A method and apparatus for testing of injectables / any sterile preparations, to determine the presence of microorganisms, in which the prepared solution is flowed through a microporous membrane filter.

    Steam sterilization (121C, 15 lbs Pressure for 15 min) Dry Heat sterilization (170C/1 Hr or 140C /3 hrs or Suitable temp. & times) Gas sterilization (Ethylene Oxide, Chlorine Dioxide) Sterilization by Radiation (Gamma sterilization, UV sterilization) By filtration (Membrane filtration & Cartridge filtration)

    THANK YOU

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