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    Sterikon

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    László Sági
    The document describes a bioindicator called Sterikon plus that changes color to indicate if a steam sterilization process was effective. It contains bacterial spores that will change the liquid in the bioindicator from red-violet to yellow-orange if sterilization was inadequate. The bioindicator allows easy monitoring of autoclave sterilization processes to ensure effectiveness and detect any issues.

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    © All Rights Reserved
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    Sterikon

    Uploaded by

    László Sági
    26 views4 pages
    The document describes a bioindicator called Sterikon plus that changes color to indicate if a steam sterilization process was effective. It contains bacterial spores that will change the liquid in the bioindicator from red-violet to yellow-orange if sterilization was inadequate. The bioindicator allows easy monitoring of autoclave sterilization processes to ensure effectiveness and detect any issues.

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    The document describes a bioindicator called Sterikon plus that changes color to indicate if a steam sterilization process was effective. It contains bacterial spores that will change the liquid in the bioindicator from red-violet to yellow-orange if sterilization was inadequate. The bioindicator allows easy monitoring of autoclave sterilization processes to ensure effectiveness and detect any issues.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    26 views4 pages

    Sterikon

    Uploaded by

    László Sági
    The document describes a bioindicator called Sterikon plus that changes color to indicate if a steam sterilization process was effective. It contains bacterial spores that will change the liquid in the bioindicator from red-violet to yellow-orange if sterilization was inadequate. The bioindicator allows easy monitoring of autoclave sterilization processes to ensure effectiveness and detect any issues.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 4

    Data Sheet

    How effectively does your


    autoclave sterilize?
    Testing Assurance with the Sterikon® plus
    color coded Bioindicator
    Steam sterilization prevents contamination and is
    essential for cGMP & cGLP operations. But results Benefits
    aren’t visible, so how can you confirm the effective- • Easy to use: Simply autoclave, incubate and
    ness? Was the procedure adequate? Is the autoclave read results
    functioning optimally? Merck Millipore offers a simple • Vibrant colors: Red-violet indicates adequate
    and yet secure solution: the Sterikon® plus Bioindicator. sterilization; yellow-orange indicates inadequate
    sterilization
    Fully compliant with USP standards, the Sterikon®
    • Complete solution: The ampoules contain everything
    plus Bioindicator consists of ampoules that contain
    you need for the test
    everything required: nutrient broth, sugar, pH indicator
    • Reliable results: Fully compliant with USP guidelines
    and nonpathogenic bacterial spores. The ampoules
    • Safe handling: Secure, high-quality ampoules with
    display vibrant, color-coded results after autoclaving nonpathogenic bacterial spores
    and incubation: red-violet indicates correct steriliza-
    tion, whereas yellow-orange warns of inadequate
    procedures. Clear, reliable answers allow you to
    easily monitor your autoclaving process and, if
    necessary, quickly introduce corrective measures to
    avoid health risks.
    Principle
    The Sterikon® plus Bioindicator consists of an ampule
    that contains nutrient broth, sugar, a pH indicator
    and spores of an apathogenic organism, Geobacillus
    stearothermophilus ATCC 79531 (sporulation optimized).
    The thermal resistance is such that the spores are totally
    killed after 15 minutes when heated in compressed
    steam at a temperature of 121°C ± 0.5°C (1 bar). At
    lower temperatures or lower exposure times, the spores
    can survive, at least partly. The ampules are placed into
    the autoclave along with the batch to be sterilized.
    After autoclaving, the success of the sterilization
    process is checked by incubation of the ampules. No
    growth of Geobacillus stearothermophilus indicates
    adequate sterilization, whereas growth shows
    inadequate sterilization.

    Application
    The Merck Millipore Sterikon® plus Bioindicator
    System is used to monitor the effectiveness of
    steam sterilization at 121°C for 15 minutes.
    Procedure Specifications
    The ampules are placed in the autoclave at sites The specifications of Sterikon® plus Bioindicator
    where the most unfavorable conditions for are as follows:
    sterilization are thought to exist, i.e. at the n = 5 x 105 – 1 x 107 spores per unit
    bottom and in the middle of the autoclave. D121* = 1.5 – 2.0 minutes
    F121 = 15 minutes
    After sterilization, the ampules are removed
    and incubated up to 48 hours at 60 ± 2°C. A In accordance with the USP, the heat resistance and
    non-sterilized ampule should also be incubated the number of spores are optimized so that after
    to serve as a control. a sterilization time of 5 minutes (121°C ± 0.5°C)
    all ampules contain living spores, whereas after
    Do not use the ampules at temperatures exceeding
    15 minutes of sterilization (121°C ± 0.5°C) all spores
    125°C since overheating may result in color changes
    are dead. For the period in between, ampules can
    without spore growth. Complete instructions for
    be found with either living or dead spores.
    proper use are included with each order. Consult the
    instructions before using the product. * D-value is determined at the time of manufacture
    using fraction negative analysis. The D-value is
    reproducible at the stated temperature and only
    Evaluation under the exact conditions at which it was determined;
    the user may not necessarily obtain the same results.
    If sterilization is adequate, the Geobacillus
    stearothermophilus spores are killed off. The
    contents of the ampules remain transparent to
    Stability
    slightly opalescent and red-violet in color. When stored at the prescribed temperature (+ 2°C
    If sterilization is inadequate, the Geobacillus to + 8°C ) in a refrigerator, the bioindicator is stable
    stearothermophilus spores survive. The contents up to the expiration date printed on the pack.
    of the ampules then usually turn yellow-orange Sterikon® plus Bioindicator has a shelf life of
    within 24 hours due to the formation of 18 months from the date of manufacture.
    acid as a result of sugar fermentation and may
    become turbid due to microbial growth. In cases Ordering Information
    in which the spores are partially damaged, the
    Catalog No. Quantity
    reaction may be delayed to 48 hours.
    1.10274.0001 15 ampules
    The contents of the control ampule also turn
    1.10274.0002 100 ampules
    yellow-orange and may become turbid. If this does
    Each with 2 ml of spore suspension
    not occur, consider the test invalid.

    red-violet color indicates correct sterilization,


    yellow-orange warns of inadequate procedures
    We provide information and advice to our customers on application technologies and regulatory matters to the best of our knowledge and ability,
    but without obligation or liability. Existing laws and regulations are to be observed in all cases by our customers. This also applies in respect to any
    rights of third parties. Our information and advice do not relieve our customers of their own responsibility for checking the suitability of our
    products for the envisaged purpose.

    For more information on our products:


    www.merckmillipore.com/biomonitoring
    Find contact information for your country at:
    www.merckmillipore.com/offices
    For Technical Service, please visit:
    www.merckmillipore.com/techservice

    Merck KGaA
    Frankfurter Straße 250
    64293 Darmstadt, Germany
    e-mail: mibio@merckgroup.com

    Merck Millipore and the M logo are trademarks of Merck KGaA, Darmstadt, Germany.
    Sterikon is a registered trademark of Merck KGaA, Darmstadt, Germany.
    All other trademarks are the property of their respective owners. Caution: For use as a manufacturing component. Industrial use only.
    Lit No. DS3300EN00 01/2014 Printed in Germany. Not for use in a healthcare facility or to release clinical healthcare products.
    © 2014 Merck KGaA, Darmstadt, Germany. All rights reserved.

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