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    Sop 3

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    Dolly Bijani
    This standard operating procedure outlines the steps for performing a bacterial endotoxin test (BET) to detect endotoxins in pharmaceuticals and medical devices. Key responsibilities include microbiologists conducting the tests following the procedure, and quality assurance overseeing compliance. The procedure involves preparing reagents and controls, diluting samples, incubating mixtures of samples and lysate reagent, quantifying endotoxin levels, recording results, and disposing of biohazards properly. All personnel must receive training and demonstrate competency before testing independently.

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    Sop 3

    Uploaded by

    Dolly Bijani
    15 views2 pages
    This standard operating procedure outlines the steps for performing a bacterial endotoxin test (BET) to detect endotoxins in pharmaceuticals and medical devices. Key responsibilities include microbiologists conducting the tests following the procedure, and quality assurance overseeing compliance. The procedure involves preparing reagents and controls, diluting samples, incubating mixtures of samples and lysate reagent, quantifying endotoxin levels, recording results, and disposing of biohazards properly. All personnel must receive training and demonstrate competency before testing independently.

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    SOP 3

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    This standard operating procedure outlines the steps for performing a bacterial endotoxin test (BET) to detect endotoxins in pharmaceuticals and medical devices. Key responsibilities include microbiologists conducting the tests following the procedure, and quality assurance overseeing compliance. The procedure involves preparing reagents and controls, diluting samples, incubating mixtures of samples and lysate reagent, quantifying endotoxin levels, recording results, and disposing of biohazards properly. All personnel must receive training and demonstrate competency before testing independently.

    Copyright:

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

    Sop 3

    Uploaded by

    Dolly Bijani
    This standard operating procedure outlines the steps for performing a bacterial endotoxin test (BET) to detect endotoxins in pharmaceuticals and medical devices. Key responsibilities include microbiologists conducting the tests following the procedure, and quality assurance overseeing compliance. The procedure involves preparing reagents and controls, diluting samples, incubating mixtures of samples and lysate reagent, quantifying endotoxin levels, recording results, and disposing of biohazards properly. All personnel must receive training and demonstrate competency before testing independently.

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    Standard Operating Procedure (SOP) for BET Test (Bacterial Endotoxin Test)

    Objective:

    The objective of this SOP is to define the procedure for performing the Bacterial Endotoxin Test (BET) to
    assess the presence of endotoxins in pharmaceutical products, medical devices, or raw materials.

    Scope:

    This SOP applies to laboratory personnel responsible for performing BET tests within the microbiology
    department.

    Responsibilities:

    Microbiologist: Responsible for conducting BET tests following this SOP.

    Quality Assurance: Responsible for overseeing compliance with this SOP and approving test results.

    Procedure:

    Prepare the necessary reagents and equipment required for the BET test, ensuring they are within their
    expiration date and properly calibrated.

    Prepare standard endotoxin solutions as per the manufacturer's instructions.

    Dilute the sample to be tested as necessary using pyrogen-free water or appropriate diluents.

    Prepare the positive product control and negative product control samples.

    Dispense the sample, standard endotoxin solutions, and controls into appropriate test tubes or wells.

    Add the LAL (Limulus Amebocyte Lysate) reagent to each tube or well according to the manufacturer's
    instructions.

    Incubate the samples and controls at the specified temperature for the recommended duration.

    After incubation, visually inspect each tube or well for gel formation or other indications of endotoxin
    presence.
    Perform the kinetic chromogenic or turbidimetric method to quantify endotoxin levels in the samples.

    Calculate the endotoxin concentration in each sample using standard curves or software provided by the
    manufacturer.

    Record all observations, calculations, and results accurately in the designated logbook or electronic
    system.

    Notify Quality Assurance of any deviations from expected results or procedural errors.

    Dispose of all biohazardous materials according to established protocols.

    Documentation:

    BET test record

    Deviation report (if applicable)

    Training:

    All personnel involved in performing BET tests must receive training on this SOP and demonstrate
    competency before conducting tests independently.

    References:

    United States Pharmacopeia (USP) Chapter <85>

    European Pharmacopoeia (Ph. Eur.) Chapter 2.6.14

    Manufacturer's instructions for reagents and equipment

    Revision History:

    Any revisions to this SOP must be documented, and all affected personnel must be notified of the
    changes.

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