ASTM WK43975

    New Practice for Determining and Characterizing BioProcess Extractables from Components, Subassemblies, and Assemblies Used in Single-Use Applications: Part 1-Preparation of Extractables Test Solutions

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    Developed by Subcommittee: E55.04 | Committee E55 | Contact Staff Manager



    WK43975

    1. Scope

    1.1 This practice defines the standard method to create extraction samples from single-use bioprocess systems using model bioprocess extraction solutions. Specifically, these extraction tests are done to identify the spectrum of typical chemical substances that could solubilize and migrate into the process fluid upon contact with process fluids and potentially could affect the process or alter the final drug substance (or API) or drug product. Data generated from these studies may be used to make risk-based decisions as to the potential impact on the final drug substance (or API) or drug product and aid in the selection of equipment/components. 1.2 This practice covers only the preparation of extractables test solutions. Analysis of these extractables test solution is covered in a separate practice (WK43975 Part 2: Analysis of Extractables Test Solutions, in development). 1.3 This practice covers the following classification of single-use components: 1.3.1 Bags and films used for storage, mixing, or as bioreactors; 1.3.2 Tubing; 1.3.3 Tubing connectors and disconnectors; 1.3.4 Aseptic connectors and disconnectors; 1.3.5 Sterilizing-grade and process filters; 1.3.6 Tangential flow filtration cassettes; 1.3.7 Sensors; 1.3.8 Valves; 1.3.9 Elastomeric parts (gaskets, O-rings, diaphragms, and septum); 1.3.10 Wetted polymer surfaces of positive displacement pumps; 1.3.11 Chromatography columns; 1.3.12 Molded parts of mixers (for example, impellers); and 1.3.13 Filling needles.


    Keywords

    extractables; leachables; single-use applications; SUT; biopharmaceuticals; pharmaceuticals; risk assesssment; toxicological

    The title and scope are in draft form and are under development within this ASTM Committee.

    Citing ASTM Standards
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    Work Item Status

    Date Initiated:
    11-07-2013

    Technical Contact:
    James Bray

    Item:
    001

    Ballot:
    E55.04 (15-02)

    Status:
    Negative Votes Need Resolution