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    Using Bis in Triplicate For VHP Processes: Mesa Laboratories, Inc. 625 Zoot Way Bozeman, MT 59718 Tel: 877.746.8883

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    farihaulfah
    Using triplicate biological indicators (BIs) at challenge locations allows for more accurate monitoring of vapor phase hydrogen peroxide (VHP) sterilization processes. VHP has limited penetration, so triplicate BIs identify if any growth is from isolated surviving spores or large numbers. Triplicate BIs that show growth in one indicator but not the others still demonstrate a 6 log reduction was achieved. The article provides details on how triplicate BIs are used to test VHP sterilization efficacy.

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    Using Bis in Triplicate For VHP Processes: Mesa Laboratories, Inc. 625 Zoot Way Bozeman, MT 59718 Tel: 877.746.8883

    Uploaded by

    farihaulfah
    140 views2 pages
    Using triplicate biological indicators (BIs) at challenge locations allows for more accurate monitoring of vapor phase hydrogen peroxide (VHP) sterilization processes. VHP has limited penetration, so triplicate BIs identify if any growth is from isolated surviving spores or large numbers. Triplicate BIs that show growth in one indicator but not the others still demonstrate a 6 log reduction was achieved. The article provides details on how triplicate BIs are used to test VHP sterilization efficacy.

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    bi H1O2

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    BI H2O2

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    Using triplicate biological indicators (BIs) at challenge locations allows for more accurate monitoring of vapor phase hydrogen peroxide (VHP) sterilization processes. VHP has limited penetration, so triplicate BIs identify if any growth is from isolated surviving spores or large numbers. Triplicate BIs that show growth in one indicator but not the others still demonstrate a 6 log reduction was achieved. The article provides details on how triplicate BIs are used to test VHP sterilization efficacy.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    140 views2 pages

    Using Bis in Triplicate For VHP Processes: Mesa Laboratories, Inc. 625 Zoot Way Bozeman, MT 59718 Tel: 877.746.8883

    Uploaded by

    farihaulfah
    Using triplicate biological indicators (BIs) at challenge locations allows for more accurate monitoring of vapor phase hydrogen peroxide (VHP) sterilization processes. VHP has limited penetration, so triplicate BIs identify if any growth is from isolated surviving spores or large numbers. Triplicate BIs that show growth in one indicator but not the others still demonstrate a 6 log reduction was achieved. The article provides details on how triplicate BIs are used to test VHP sterilization efficacy.

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    Apex Discs - Triplicates Using BIs in Triplicate for VHP Processes

    Some sterilization processes, such as saturated steam under pressure with a pre-vacuum air
    removal, have great penetrative capabilities. The same is not true for ambient pressure gas-
    sing processes such as vapor phase hydrogen peroxide (VHP) at ambient pressures. Due to the
    limited penetrating capability of VHP, any presence of debris amongst the spores can also lead
    to spores surviving VHP exposures where kill was otherwise expected; a concept referred to as
    ‘‘rogue BIs’’ in various publications. Section 8.1 of PDA Technical Report No. 51 suggests that re-
    running the cycle with a different lot of BIs or re-running the cycle with duplicate or triplicate BIs
    in the same location may be necessary.

    The reason to use multiple BIs at each test location is because we need each BI to be a statisti-
    cal replicate of its neighbor. Instead of monitoring 100 discrete locations throughout the isola-
    tor, the validation technician can identify the 30 or 40 most difficult to sterilize locations and use
    triplicate BIs at each of these challenge locations, thus consuming 90 or 120 BIs per cycle. When
    only one BI is used at each test location, and that one BI yields a growth-positive result, there
    is no way to calculate if that result was due to one surviving spore, or hundreds-of-thousands of
    surviving spores.

    Despite one growth-positive BI at a location of triplicate BIs, one can still document that a 6+
    spore log reduction was achieved at that particular test location. Do be advised that this calcula-
    tion is ONLY possible when replicate BIs are used. To find out more about how triplicate BIs are
    being used in VHP, click the link below to read the Spore News article on the subject.

    http://www.mesalabs.com/wp-content/uploads/2012/09/Spore-News-Vol-9-No4.pdf

    • Packaged in Tyvek/Tyvek

    • Discs measure 0.35” diameter x 0.008” thick

    • Tyvek packaged indicators have perforations for hanging and a thumb notch for peeling

    • Available with reference #12980 or #7953

    • Catalog #HMV-091T

    Mesa Laboratories, Inc. Tel: 877.746.8883


    625 Zoot Way www.MesaLabs.com
    Bozeman, MT 59718 bicustomerservice@mesalabs.com
    Apex Biological Indicators General Method:
    • Place Tri-Scale Bis in selected sites throughout test enclosure
    • Conduct an exposure time estimated to be near the 6 log reduction point
    • Retrieve Tri-Scale Bis, culture, and observe for outgrowth
    • Based on outgrowth patterns, identify worst-case location(s) in enclosure
    • Use fractional outgrowth results to estimate a probable 6 log reduction cycle

    For example, a location where the 1x105 and 1x105 carriers grew had adequate sterilant to kill
    1x104 spores, but not 1x105 spores, and will require a longer cycle to ensure steriliza­tion of this
    location.

    Microbial Suspensions
    • G. stearothermophilus for gaseous hydrogen peroxide
    • Custom applications and custom preparations

    Testing
    • Complete System Validations
    • Propagation and Resistance Testing of Environmental Isolates

    Mesa Laboratories, Inc. Tel: 877.746.8883


    625 Zoot Way www.MesaLabs.com
    Bozeman, MT 59718 bicustomerservice@mesalabs.com

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