ASTM WK30195

    New Guide for Subvisible Particle Measurement in Biopharmaceutical Manufacturing Using Dynamic (Flow) Imaging Microscopy

    (What is a Work Item?)

    Developed by Subcommittee: E55.03 | Committee E55 | Contact Staff Manager


    1. Scope

    This is a starting document that will be a base working group to bring together manufactures and users to outline particle analysis systems . It will cover PAT and lab systems . A key starting point was the discussion today between Chris Watts(FDA),Paul Gil(Bayer) and Tod Canty (J M Canty Inc).The end users in the Pharma and BioPharma industrys are being asked to deal with Sub-visible particles down through 1 micron. .In discussions with Paul Gil he mentioned there is a tremendous industry wide effort to get numbers ,understand the meaning and solve issues of sub-visible particles. Our scope will be to put a guide together of various particle sizing systems ,there strengths and weaknesses in Pharma . We will also have a few side goals. 1)target sub-visible particles analysis issue 2)particle characterization methods and their use 3)decide what data is needed and how to use the data 4)particle analysis in relation to water (WFI and CIP) 5)API ,crystallization and filtration I would expect that when our work is accomplished we would become a standing group and have several other work item spin off

    The industry is being asked to do non-visible ppm level analysis with no guidance or approved methods. There is also a need for a guide to see all the options a user may have in the particle analysis area so they can do a good comparative study based on their product and needs.


    laser:microscopy:fluid imaging:digit imaging:ultrasonic

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

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    Work Item Status

    Date Initiated:

    Technical Contact:
    Paul Gil


    E55 (16-01)

    Ballot Item Approved as E3060-2016 and Pending Publication